Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631001
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
The Effect of Abdominal Massage on Gastrointestinal Functions in Mechanically Ventilated Patients Receiving Enteral Nutrition in Intensive Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Abdominal Massage on Gastrointestinal Functions in Mechanically Ventilated Patients Receiving Enteral Nutrition in Intensive Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMGF-ICU
Brief Summary:
This study aims to evaluate the effects of abdominal massage on gastrointestinal functions in mechanically ventilated patients receiving enteral nutrition in intensive care units
Detailed Description:
Intensive care units ICUs are areas where advanced technologies and multidisciplinary care are provided together to sustain and treat critically ill patients Patients treated in the ICU due to reasons such as inadequate gas exchange increased respiratory workload and inability to maintain airway patency are intubated and placed on mechanical ventilation support ICU patients dependent on mechanical ventilators become reliant on external nutrition during the treatment process as they cannot meet their nutritional needs In ICU patients damage to the digestive mucosa due to stress may occur leading to various gastrointestinal GI problems such as increased residual volume diarrhea constipation and malnutrition Therefore providing accurate and adequate nutritional support is critically important in the treatment processes of ICU patients In recent years nutritional support has been included among therapeutic methods in ICUs Studies have shown that appropriately timed nutritional support positively affects the clinical outcomes of patients in intensive care units Enteral or parenteral nutrition methods can be chosen based on the patients health status and guidelines
For ICU patients on mechanical ventilator support if the gastrointestinal tract is functional enteral nutrition is frequently preferred Enteral nutrition is the delivery of nutrients to the stomach or small intestine via a tube catheter or stoma Enteral nutrition is a commonly used method for patients who cannot eat orally It can reduce infection risk shorten catabolic responses the formation of gastric ulcers and the length of hospital stay In a study by Mamoru Hayashi et al 2024 it was reported that starting enteral nutrition within the first 48 hours for patients admitted to the ICU shortened hospital stay and reduced mortality rates
Although enteral nutrition has high physiological response rates there are also risks and potential side effects The most common GI complications encountered in patients receiving enteral nutrition are gastrointestinal complications GI complications in enteral nutrition are influenced by many factors including the patients general condition mechanical ventilation hemodynamic parameters and administered medications These complications include aspiration diarrhea constipation abdominal distension and nauseavomiting These side effects have been observed in 62 of patients receiving this type of nutrition Constipation is a digestive system complication that is often overlooked in ICU patients Immobility hypotension the use of vasopressors and narcotics and lack of access to appropriate conditions and facilities are among the reasons for constipation development Constipation prolongs the duration of mechanical ventilation and increases the length of stay in ICUs In a study evaluating enteral nutrition complications 485 of the patients experienced dislodgement of their nasogastric tube 455 had electrolyte imbalances 345 developed hyperglycemia 328 had diarrhea 297 experienced constipation 204 had vomiting and 31 developed pulmonary aspiration In another study Mentec et al 2001 found that 32 of ICU patients receiving enteral nutrition experienced increased gastric residual volume and 46 developed gastrointestinal intolerance
GI problems encountered in ICUs can be prevented reduced and patient comfort can be increased through pharmacological and non-pharmacological treatments abdominal massage aromatherapy acupuncture mobilization etc In a study by Röhm et al 2008 investigating nutrition and motility issues in ICUs it was found that non-pharmacological methods in addition to pharmacological methods were also highlighted and abdominal massage was applied in 39 of cases against motility problems Non-pharmacological methods have various advantages over pharmacological approaches The most important advantage of these methods is that they can be easily applied to individuals Additionally they offer a more cost-effective solution in terms of both patient and hospital costs
Abdominal massage which aims to stimulate and increase intestinal peristalsis is performed by applying effleurage petrissage and vibration techniques clockwise on the abdomen for 15-20 minutes Abdominal massage performed by nurses caregivers or family members is a safe non-invasive method with no known side effects This massage has been shown to be effective for those experiencing defecation issues abdominal pain caused by gas or cramps individuals with altered abdominal muscle tone and those suffering from fecal incontinence or chronic constipation Studies evaluating the effectiveness of abdominal massage in preventing GI complications in ICUs are relatively limited In a study by Okuyan et al 2019 it was found that abdominal massage was effective in reducing constipation and improving quality of life In a study by Uysal et al 2012 conducted on patients receiving enteral nutrition in neurology and neurosurgery clinics it was stated that abdominal massage could be used to prevent abdominal distension and increased gastric residual volume GRV According to a study conducted in Germany it was reported that abdominal massage began to be used to improve GI complications in 388 of ICU patients
There are studies in the literature examining the effects of abdominal massage on gastrointestinal system functions Existing studies generally focus on the effects of abdominal massage on geriatric patient populations or evaluate it in intensive care patients with limited parameters However this research will specifically investigate the effects of abdominal massage on gastrointestinal system functions in patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit The findings of this study will contribute to the adoption and standardization of abdominal massage practices by intensive care nurses in the care of this specific patient group supported by scientific evidence To contribute to this area in the literature the study aims to evaluate the effects of abdominal massage on gastric residual volume frequency of defecation and abdominal distension in mechanically ventilated patients receiving enteral nutrition in the intensive care unit
Three different sets of hypotheses have been established in the study These are
First Hypothesis Set H0 Abdominal massage applied to patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit has no effect on the frequency of defecation
H1 Abdominal massage applied to patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit has an effect on the frequency of defecation
Second Hypothesis Set H0 Abdominal massage applied to patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit has no effect on abdominal distension
H1 Abdominal massage applied to patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit has an effect on abdominal distension
Third Hypothesis Set H0 Abdominal massage applied to patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit has no effect on gastric residual volume
H1 Abdominal massage applied to patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit has an effect on gastric residual volume
Method Type of Research The study is designed as a prospective single-blind randomized controlled trial to determine the effects of abdominal massage on gastrointestinal system functions frequency of defecation abdominal distension gastric residual volume in mechanically ventilated patients receiving enteral nutrition in the intensive care unit The research is prepared based on the 25-item checklist and flowchart included in the Consolidated Standards of Reporting Trials CONSORT-2017 The studys Clinical Trials protocol registration will be done via ClinicalTrialsgov
Location and Characteristics of the Research The research will be conducted at Mersin Toros State Hospitals general and surgical intensive care units between December 2024 and May 2025 The internal intensive care unit at Mersin Toros State Hospital has 9 beds while the surgical intensive care unit has 10 beds The general intensive care unit consists of two separate rooms with the first room containing 2 isolation rooms and a 3-bed ward system and the second room having a 4-bed ward system separated by a wall There are 22 nurses working in the general intensive care unit The surgical intensive care unit is located in a single room with a 9-bed ward system separated by walls and includes 1 isolation room There are 24 nurses in the surgical intensive care unit and health personnel from both units provide shared services including a total of 8 clinical support staff 6 cleaning staff 1 attendant 1 security personnel and 1 medical secretary The same physicians are on duty in both intensive care units totaling 13 anesthesia specialists and 1 intensive care specialist Both intensive care units are at level 3 and since enteral nutrition is administered cyclically the patients are similar The enteral nutrition planning for patients in the intensive care units will be done in cooperation with nutrition nurses and dietitians The planned enteral nutrition will be administered and monitored by the nurses
Randomization The listing of individuals forming the study sample will be done by an independent researcher who is not participating in the study After obtaining consent from the relatives of patients who are willing to participate in the study and meet the criteria the allocation of patients to the intervention or control group will be determined randomly using the website randomizerorg Individuals included in the sampling will be listed from 1 to 70 The program will input the information that there will be two different groups of 35 individuals and that participants are numbered between 1 and 70 The program will randomly assign the two groups The individuals listed by an independent researcher will be randomly numbered by the system randomizerorg
Blinding Due to the nature of the study the researcher will not be blinded Thus the research will be conducted as a single-blind randomized controlled trial Upon completion of the study data will be entered into the computer by an independent researcher without specifying the intervention or control group coded as groups A and B Data analysis and the writing of the research report will be conducted by a statistician who does not know which group is which using the codes A and B
Data Collection Preparation of Data Collection Tools A Data Collection Form has been used in the data collection phase of the research The data will be collected using a data collection form consisting of three sections Patient Clinical Condition Information Form Enteral Nutrition Monitoring Form and Bristol Stool Consistency Scale
Patient Clinical Condition Information Form This form containing patient clinical condition information has been prepared by the researcher to determine the socio-demographic characteristics of the participants after a review of the relevant literature It includes an assessment of individual characteristics the APACHE II Acute Physiology and Chronic Health Evaluation scoring system and the Glasgow Coma Scale GCS Individual characteristics include age gender reason for admission to intensive care chronic disease status sedation status intubation and the start date of enteral nutrition
APACHE II Scale This scale is used for the evaluation of a patients acute physiological and chronic health condition it was developed to provide an objective assessment of the mortality risk severity and criticality of diseases in patients in the intensive care unit The scoring range is between 12-71 As the score increases the patients prognosis worsens
GCS This will be used to assess the patients level of consciousness The scale assesses a patient as being in a coma if the score is between 0-3 stupor if between 3-8 confused if between 8-13 and oriented if between 13-14
Enteral Nutrition Monitoring Form The enteral nutrition monitoring form was created by the researcher according to the literature This form will record the frequency of defecation abdominal distension GRV measurement and the rate of intake of the nutritional solution to evaluate the effectiveness of gastrointestinal functions
Frequency of Defecation This is the assessment of patients daily bowel movement status and is derived from routine patient monitoring forms in the intensive care unit
Abdominal Distension This is evaluated by applying pressure to the abdominal wall using the palpation method assessing the tension of the abdominal wall during the applied pressure
GRV Measurement This refers to the volume of stomach contents measured by aspiration via a nasogastric tube using a syringe
Bristol Stool Consistency Scale Developed by a team of gastroenterologists in 1997 at the University of Bristol in England the Bristol Stool Consistency Scale is used to assess stool form and provide information about changes in bowel habits and possible pathological conditions in the bowel This scale is designed to classify stool into seven separate categories reflecting an individuals bowel movements According to the Bristol Stool Consistency Scale Types 1 and 2 indicate constipation Types 3 and 4 indicate normal stool and Types 5 6 and 7 indicate diarrhea
Implementation of Data Collection Forms The study has two groups assigned through randomization intervention and control Relatives of patients meeting the research criteria will be informed about the study in the General Intensive Care and Surgical Intensive Care units at Mersin Toros State Hospital Informed consent forms will be signed by the relatives of patients who agree to participate in the study and the data collection forms will be implemented Relatives in the intervention group will be informed about the procedure and abdominal massage along with routine nursing care will be applied to the accepted patients
Implementation Environment The study will be conducted at the bedside in the General Intensive Care and Surgical Intensive Care Units of Mersin Toros State Hospital To ensure patient privacy the curtains at the bedside will be drawn The intervention will be carried out one-on-one at the patients bedside
Implementation Position In the intervention group in addition to routine nursing care abdominal massage will be applied while the patients head will be elevated at an angle of 30-45 in a semi-fowler position before enteral nutrition is started The patient should be stable during the abdominal massage and monitoring should be conducted carefully Routine nursing care will be applied to the control group During enteral feeding the head elevation will be maintained at an angle of 30-45
FrequencyDuration of Implementation Based on previous studies abdominal massage will be performed twice a day at 1500 and 2100 for each patient over a total of 3 days Each abdominal massage session will last for 15 minutes Massage measurements will be taken afterward
Stages of Abdominal Massage Application
Abdominal massage consists of four fundamental movements superficial effleurage stroking deep effleurage petrissage kneading and vibration Effleurage stroking is a technique applied with the palm or fingers over the abdominal area in both deep and superficial movements Abdominal massage begins and ends with effleurage During superficial effleurage a movement is made with the palm from over the iliac bones to both sides of the pelvis and down towards the groin Deep effleurage is applied along the ascending colon transverse colon and descending colon to support the movement of fecal contents through the intestines In the petrissage technique circular movements of the hands and fingers lift the muscle mass and compress the tissue It is applied upwards along the ascending colon and downwards along the descending colon It should not be repeated continuously in the same area The vibration technique consists of vibration movements performed with the hands and fingers over the same muscle in the abdominal area This method helps expel gas from the intestines
Flow of the Research Process
First Stage Preparation Stage A suitable environmental arrangement will be made in the General Intensive Care and Surgical Intensive Care Units of Mersin Toros State Hospital for the patients included in the intervention and control groups
Second Stage Application Stage This stage will consist of four steps
First Step In the first step of the application brief information about the research will be provided to the relatives of eligible patients at Mersin Toros State Hospital General Intensive Care and Surgical Intensive Care Units and written consents will be obtained from the relatives
Second Step Sampling will be completed according to the inclusion exclusion and withdrawal criteria of the study followed by randomization to form two randomized groups The purpose and process of the research will be explained to the patientrelative individuals who will then fill out the Informed Consent Form and the Patient Clinical Status Information Form Routine nursing care procedures will be applied to both groups
Third Step The abdominal massage procedure will be performed on the first day at 1500 After a 30-minute break from enteral feeding GRV measurements will be recorded using a syringe abdominal distension measurements will be taken by palpation and defecation counts will be recorded using the nurse observation form in the Enteral Feeding Monitoring Form The appearance of the stool will be evaluated by the researcher according to the Bristol Stool Form Scale The intervention group will receive a 15-minute abdominal massage No intervention will be made in the control group other than routine nursing care
Fourth Step The abdominal massage procedure will be performed on the first day at 2100 After a 30-minute break from enteral feeding at 2030 GRV measurements will be recorded using a syringe abdominal distension measurements will be taken by palpation and defecation counts will be recorded using the nurse observation form in the Enteral Feeding Monitoring Form The appearance of the stool will be evaluated by the researcher according to the Bristol Stool Form Scale The intervention group will receive a 15-minute abdominal massage No intervention will be made in the control group other than routine nursing care
In the intervention group abdominal massage will be performed for a total of 6 sessions over 3 days twice daily using the Enteral Feeding Monitoring Form and Bristol Stool Form Scale with measurements recorded
In the control group no interventions will be made other than routine nursing care throughout the 3-day process Measurements will also be recorded using the Enteral Feeding Monitoring Form and Bristol Stool Form Scale twice a day for a total of 6 sessions To eliminate ethical issues that may arise in the control group abdominal massage will be performed on these patients after the data collection process of the research is completed
Third Stage Reporting Stage In this stage the statistical analysis of the data obtained from the patients will be performed and the research report will be written
Ethical Aspect of the Research
The research will be conducted in accordance with the Helsinki Declaration Written ethical approval will be obtained from the Mersin University Clinical Research Ethics Committee and written permission from the Mersin Provincial Health Directorate before data collection begins Written permissions will also be obtained from the developers of the scales planned to be used in the research Patient selection in the research will be based on voluntary participation Principles of confidentiality and privacy will be observed and patientsrelatives will be informed that they can withdraw from the study at any time after which their written consents will be obtained Furthermore patients will be informed that all data collected will be kept confidential and stored securely by the researcher
Data Evaluation
The data obtained from the research will be evaluated using appropriate statistical methods Parametric or non-parametric tests will be used based on the normal distribution of comparative data analysis Descriptive statistics will include counts and percentages For normally distributed data mean and standard deviation values will be provided while for non-normally distributed data minimum and maximum values along with median and 25th-75th percentiles will be reported
For ICU patients on mechanical ventilator support if the gastrointestinal tract is functional enteral nutrition is frequently preferred Enteral nutrition is the delivery of nutrients to the stomach or small intestine via a tube catheter or stoma Enteral nutrition is a commonly used method for patients who cannot eat orally It can reduce infection risk shorten catabolic responses the formation of gastric ulcers and the length of hospital stay In a study by Mamoru Hayashi et al 2024 it was reported that starting enteral nutrition within the first 48 hours for patients admitted to the ICU shortened hospital stay and reduced mortality rates
Although enteral nutrition has high physiological response rates there are also risks and potential side effects The most common GI complications encountered in patients receiving enteral nutrition are gastrointestinal complications GI complications in enteral nutrition are influenced by many factors including the patients general condition mechanical ventilation hemodynamic parameters and administered medications These complications include aspiration diarrhea constipation abdominal distension and nauseavomiting These side effects have been observed in 62 of patients receiving this type of nutrition Constipation is a digestive system complication that is often overlooked in ICU patients Immobility hypotension the use of vasopressors and narcotics and lack of access to appropriate conditions and facilities are among the reasons for constipation development Constipation prolongs the duration of mechanical ventilation and increases the length of stay in ICUs In a study evaluating enteral nutrition complications 485 of the patients experienced dislodgement of their nasogastric tube 455 had electrolyte imbalances 345 developed hyperglycemia 328 had diarrhea 297 experienced constipation 204 had vomiting and 31 developed pulmonary aspiration In another study Mentec et al 2001 found that 32 of ICU patients receiving enteral nutrition experienced increased gastric residual volume and 46 developed gastrointestinal intolerance
GI problems encountered in ICUs can be prevented reduced and patient comfort can be increased through pharmacological and non-pharmacological treatments abdominal massage aromatherapy acupuncture mobilization etc In a study by Röhm et al 2008 investigating nutrition and motility issues in ICUs it was found that non-pharmacological methods in addition to pharmacological methods were also highlighted and abdominal massage was applied in 39 of cases against motility problems Non-pharmacological methods have various advantages over pharmacological approaches The most important advantage of these methods is that they can be easily applied to individuals Additionally they offer a more cost-effective solution in terms of both patient and hospital costs
Abdominal massage which aims to stimulate and increase intestinal peristalsis is performed by applying effleurage petrissage and vibration techniques clockwise on the abdomen for 15-20 minutes Abdominal massage performed by nurses caregivers or family members is a safe non-invasive method with no known side effects This massage has been shown to be effective for those experiencing defecation issues abdominal pain caused by gas or cramps individuals with altered abdominal muscle tone and those suffering from fecal incontinence or chronic constipation Studies evaluating the effectiveness of abdominal massage in preventing GI complications in ICUs are relatively limited In a study by Okuyan et al 2019 it was found that abdominal massage was effective in reducing constipation and improving quality of life In a study by Uysal et al 2012 conducted on patients receiving enteral nutrition in neurology and neurosurgery clinics it was stated that abdominal massage could be used to prevent abdominal distension and increased gastric residual volume GRV According to a study conducted in Germany it was reported that abdominal massage began to be used to improve GI complications in 388 of ICU patients
There are studies in the literature examining the effects of abdominal massage on gastrointestinal system functions Existing studies generally focus on the effects of abdominal massage on geriatric patient populations or evaluate it in intensive care patients with limited parameters However this research will specifically investigate the effects of abdominal massage on gastrointestinal system functions in patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit The findings of this study will contribute to the adoption and standardization of abdominal massage practices by intensive care nurses in the care of this specific patient group supported by scientific evidence To contribute to this area in the literature the study aims to evaluate the effects of abdominal massage on gastric residual volume frequency of defecation and abdominal distension in mechanically ventilated patients receiving enteral nutrition in the intensive care unit
Three different sets of hypotheses have been established in the study These are
First Hypothesis Set H0 Abdominal massage applied to patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit has no effect on the frequency of defecation
H1 Abdominal massage applied to patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit has an effect on the frequency of defecation
Second Hypothesis Set H0 Abdominal massage applied to patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit has no effect on abdominal distension
H1 Abdominal massage applied to patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit has an effect on abdominal distension
Third Hypothesis Set H0 Abdominal massage applied to patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit has no effect on gastric residual volume
H1 Abdominal massage applied to patients who are mechanically ventilated and receiving enteral nutrition in the intensive care unit has an effect on gastric residual volume
Method Type of Research The study is designed as a prospective single-blind randomized controlled trial to determine the effects of abdominal massage on gastrointestinal system functions frequency of defecation abdominal distension gastric residual volume in mechanically ventilated patients receiving enteral nutrition in the intensive care unit The research is prepared based on the 25-item checklist and flowchart included in the Consolidated Standards of Reporting Trials CONSORT-2017 The studys Clinical Trials protocol registration will be done via ClinicalTrialsgov
Location and Characteristics of the Research The research will be conducted at Mersin Toros State Hospitals general and surgical intensive care units between December 2024 and May 2025 The internal intensive care unit at Mersin Toros State Hospital has 9 beds while the surgical intensive care unit has 10 beds The general intensive care unit consists of two separate rooms with the first room containing 2 isolation rooms and a 3-bed ward system and the second room having a 4-bed ward system separated by a wall There are 22 nurses working in the general intensive care unit The surgical intensive care unit is located in a single room with a 9-bed ward system separated by walls and includes 1 isolation room There are 24 nurses in the surgical intensive care unit and health personnel from both units provide shared services including a total of 8 clinical support staff 6 cleaning staff 1 attendant 1 security personnel and 1 medical secretary The same physicians are on duty in both intensive care units totaling 13 anesthesia specialists and 1 intensive care specialist Both intensive care units are at level 3 and since enteral nutrition is administered cyclically the patients are similar The enteral nutrition planning for patients in the intensive care units will be done in cooperation with nutrition nurses and dietitians The planned enteral nutrition will be administered and monitored by the nurses
Randomization The listing of individuals forming the study sample will be done by an independent researcher who is not participating in the study After obtaining consent from the relatives of patients who are willing to participate in the study and meet the criteria the allocation of patients to the intervention or control group will be determined randomly using the website randomizerorg Individuals included in the sampling will be listed from 1 to 70 The program will input the information that there will be two different groups of 35 individuals and that participants are numbered between 1 and 70 The program will randomly assign the two groups The individuals listed by an independent researcher will be randomly numbered by the system randomizerorg
Blinding Due to the nature of the study the researcher will not be blinded Thus the research will be conducted as a single-blind randomized controlled trial Upon completion of the study data will be entered into the computer by an independent researcher without specifying the intervention or control group coded as groups A and B Data analysis and the writing of the research report will be conducted by a statistician who does not know which group is which using the codes A and B
Data Collection Preparation of Data Collection Tools A Data Collection Form has been used in the data collection phase of the research The data will be collected using a data collection form consisting of three sections Patient Clinical Condition Information Form Enteral Nutrition Monitoring Form and Bristol Stool Consistency Scale
Patient Clinical Condition Information Form This form containing patient clinical condition information has been prepared by the researcher to determine the socio-demographic characteristics of the participants after a review of the relevant literature It includes an assessment of individual characteristics the APACHE II Acute Physiology and Chronic Health Evaluation scoring system and the Glasgow Coma Scale GCS Individual characteristics include age gender reason for admission to intensive care chronic disease status sedation status intubation and the start date of enteral nutrition
APACHE II Scale This scale is used for the evaluation of a patients acute physiological and chronic health condition it was developed to provide an objective assessment of the mortality risk severity and criticality of diseases in patients in the intensive care unit The scoring range is between 12-71 As the score increases the patients prognosis worsens
GCS This will be used to assess the patients level of consciousness The scale assesses a patient as being in a coma if the score is between 0-3 stupor if between 3-8 confused if between 8-13 and oriented if between 13-14
Enteral Nutrition Monitoring Form The enteral nutrition monitoring form was created by the researcher according to the literature This form will record the frequency of defecation abdominal distension GRV measurement and the rate of intake of the nutritional solution to evaluate the effectiveness of gastrointestinal functions
Frequency of Defecation This is the assessment of patients daily bowel movement status and is derived from routine patient monitoring forms in the intensive care unit
Abdominal Distension This is evaluated by applying pressure to the abdominal wall using the palpation method assessing the tension of the abdominal wall during the applied pressure
GRV Measurement This refers to the volume of stomach contents measured by aspiration via a nasogastric tube using a syringe
Bristol Stool Consistency Scale Developed by a team of gastroenterologists in 1997 at the University of Bristol in England the Bristol Stool Consistency Scale is used to assess stool form and provide information about changes in bowel habits and possible pathological conditions in the bowel This scale is designed to classify stool into seven separate categories reflecting an individuals bowel movements According to the Bristol Stool Consistency Scale Types 1 and 2 indicate constipation Types 3 and 4 indicate normal stool and Types 5 6 and 7 indicate diarrhea
Implementation of Data Collection Forms The study has two groups assigned through randomization intervention and control Relatives of patients meeting the research criteria will be informed about the study in the General Intensive Care and Surgical Intensive Care units at Mersin Toros State Hospital Informed consent forms will be signed by the relatives of patients who agree to participate in the study and the data collection forms will be implemented Relatives in the intervention group will be informed about the procedure and abdominal massage along with routine nursing care will be applied to the accepted patients
Implementation Environment The study will be conducted at the bedside in the General Intensive Care and Surgical Intensive Care Units of Mersin Toros State Hospital To ensure patient privacy the curtains at the bedside will be drawn The intervention will be carried out one-on-one at the patients bedside
Implementation Position In the intervention group in addition to routine nursing care abdominal massage will be applied while the patients head will be elevated at an angle of 30-45 in a semi-fowler position before enteral nutrition is started The patient should be stable during the abdominal massage and monitoring should be conducted carefully Routine nursing care will be applied to the control group During enteral feeding the head elevation will be maintained at an angle of 30-45
FrequencyDuration of Implementation Based on previous studies abdominal massage will be performed twice a day at 1500 and 2100 for each patient over a total of 3 days Each abdominal massage session will last for 15 minutes Massage measurements will be taken afterward
Stages of Abdominal Massage Application
Abdominal massage consists of four fundamental movements superficial effleurage stroking deep effleurage petrissage kneading and vibration Effleurage stroking is a technique applied with the palm or fingers over the abdominal area in both deep and superficial movements Abdominal massage begins and ends with effleurage During superficial effleurage a movement is made with the palm from over the iliac bones to both sides of the pelvis and down towards the groin Deep effleurage is applied along the ascending colon transverse colon and descending colon to support the movement of fecal contents through the intestines In the petrissage technique circular movements of the hands and fingers lift the muscle mass and compress the tissue It is applied upwards along the ascending colon and downwards along the descending colon It should not be repeated continuously in the same area The vibration technique consists of vibration movements performed with the hands and fingers over the same muscle in the abdominal area This method helps expel gas from the intestines
Flow of the Research Process
First Stage Preparation Stage A suitable environmental arrangement will be made in the General Intensive Care and Surgical Intensive Care Units of Mersin Toros State Hospital for the patients included in the intervention and control groups
Second Stage Application Stage This stage will consist of four steps
First Step In the first step of the application brief information about the research will be provided to the relatives of eligible patients at Mersin Toros State Hospital General Intensive Care and Surgical Intensive Care Units and written consents will be obtained from the relatives
Second Step Sampling will be completed according to the inclusion exclusion and withdrawal criteria of the study followed by randomization to form two randomized groups The purpose and process of the research will be explained to the patientrelative individuals who will then fill out the Informed Consent Form and the Patient Clinical Status Information Form Routine nursing care procedures will be applied to both groups
Third Step The abdominal massage procedure will be performed on the first day at 1500 After a 30-minute break from enteral feeding GRV measurements will be recorded using a syringe abdominal distension measurements will be taken by palpation and defecation counts will be recorded using the nurse observation form in the Enteral Feeding Monitoring Form The appearance of the stool will be evaluated by the researcher according to the Bristol Stool Form Scale The intervention group will receive a 15-minute abdominal massage No intervention will be made in the control group other than routine nursing care
Fourth Step The abdominal massage procedure will be performed on the first day at 2100 After a 30-minute break from enteral feeding at 2030 GRV measurements will be recorded using a syringe abdominal distension measurements will be taken by palpation and defecation counts will be recorded using the nurse observation form in the Enteral Feeding Monitoring Form The appearance of the stool will be evaluated by the researcher according to the Bristol Stool Form Scale The intervention group will receive a 15-minute abdominal massage No intervention will be made in the control group other than routine nursing care
In the intervention group abdominal massage will be performed for a total of 6 sessions over 3 days twice daily using the Enteral Feeding Monitoring Form and Bristol Stool Form Scale with measurements recorded
In the control group no interventions will be made other than routine nursing care throughout the 3-day process Measurements will also be recorded using the Enteral Feeding Monitoring Form and Bristol Stool Form Scale twice a day for a total of 6 sessions To eliminate ethical issues that may arise in the control group abdominal massage will be performed on these patients after the data collection process of the research is completed
Third Stage Reporting Stage In this stage the statistical analysis of the data obtained from the patients will be performed and the research report will be written
Ethical Aspect of the Research
The research will be conducted in accordance with the Helsinki Declaration Written ethical approval will be obtained from the Mersin University Clinical Research Ethics Committee and written permission from the Mersin Provincial Health Directorate before data collection begins Written permissions will also be obtained from the developers of the scales planned to be used in the research Patient selection in the research will be based on voluntary participation Principles of confidentiality and privacy will be observed and patientsrelatives will be informed that they can withdraw from the study at any time after which their written consents will be obtained Furthermore patients will be informed that all data collected will be kept confidential and stored securely by the researcher
Data Evaluation
The data obtained from the research will be evaluated using appropriate statistical methods Parametric or non-parametric tests will be used based on the normal distribution of comparative data analysis Descriptive statistics will include counts and percentages For normally distributed data mean and standard deviation values will be provided while for non-normally distributed data minimum and maximum values along with median and 25th-75th percentiles will be reported
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None