Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360159
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-02-15
Brief Title:
Massage for Newborns Receiving Nasal CPAP
Sponsor:
Sultan Besiktas
Organization:
TC Erciyes University
Study Overview
Official Title:
Effect of Massage on Stress Comfort and Health Parameters of Newborns Receiving Nasal CPAP
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
One of the most frequently required treatments for respiratory distress in neonatal intensive care is continuous positive airway pressure NCPAP support through the nose NCPAP application has many advantages but also disadvantages and complications
Gastric-abdominal distension which is a complication of NCPAP application is caused by gas entering the stomach and gastrointestinal tract Feeding intolerance may develop in the newborn due to abdominal distension In recent studies it has been determined that non-pharmacological methods and supportive developmental care practices used to increase the comfort and reduce pain and stress of babies who experience painful procedures such as NCPAP application and who are exposed to the stressful neonatal intensive care unit environment are effective in increasing comfort and reducing pain and stress These practices include therapeutic touch mothers voice fetal position white noise lullaby wrapping and massage In the literature a quasi-experimental study examining the effect of massage Field massage technique on the respiration heart rate and oxygen saturation of 28-34 week old newborns with respiratory distress syndrome who received nasal CPAP showed that massage had no significant effect on oxygen saturation but respiration and heart rate decreased after the massage has been determined There are studies in the literature examining the effects of therapeutic touch mothers voice fetal position white noise lullaby and wrapping in order to increase the comfort of newborns receiving nasal CPAP reduce stress and pain and prolong sleep time However no research has been found in the literature examining the effects of massage on the stress comfort and health parameters of newborns receiving nasal CPAP
Gastric-abdominal distension which is a complication of NCPAP application is caused by gas entering the stomach and gastrointestinal tract Feeding intolerance may develop in the newborn due to abdominal distension In recent studies it has been determined that non-pharmacological methods and supportive developmental care practices used to increase the comfort and reduce pain and stress of babies who experience painful procedures such as NCPAP application and who are exposed to the stressful neonatal intensive care unit environment are effective in increasing comfort and reducing pain and stress These practices include therapeutic touch mothers voice fetal position white noise lullaby wrapping and massage In the literature a quasi-experimental study examining the effect of massage Field massage technique on the respiration heart rate and oxygen saturation of 28-34 week old newborns with respiratory distress syndrome who received nasal CPAP showed that massage had no significant effect on oxygen saturation but respiration and heart rate decreased after the massage has been determined There are studies in the literature examining the effects of therapeutic touch mothers voice fetal position white noise lullaby and wrapping in order to increase the comfort of newborns receiving nasal CPAP reduce stress and pain and prolong sleep time However no research has been found in the literature examining the effects of massage on the stress comfort and health parameters of newborns receiving nasal CPAP
Detailed Description:
Purpose of the research
This research was planned to determine the effect of massage on stress behavioral-newborn stress scale and biological-salivary cortisol level comfort Newborn Comfort Behavior Scale and health parameters bilirubin level amount of food intake abdominal distension and defecation frequency of newborns receiving nasal CPAP
Research Type This research is a randomized controlled experimental study
Population and sampleStudy group
The population of the research will consist of newborn babies admitted to the Neonatal Intensive Care Unit of Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital The research sample will consist of newborns who meet the research inclusion criteria In the literature review no study was found that evaluated the effect of massage on babies stress behavioral-newborn stress scale biological-salivary cortisol level comfort and health parameters bilirubin level food intake amount abdominal distension and defecation frequency Asmarani et al 2020 in their study examining the effect of massage on salivary cortisol levels in premature newborns it was determined that they reached 39 19 intervention group 20 control group newborns Asmarani et al 2020 In this study it was decided that the number of newborns in the groups would be 18 based on α 95 confidence level and 80 power The research sample will consist of 36 newborns 18 intervention group 18 control group who meet the research inclusion criteria
Data collection tools
Newborn Information Form Diagnosis of the newborn baby gender type of birth height birth weight gestational and postnatal age Apgar score day of admission and discharge time to start nasal CPAP application total time of receiving nasal CPAP application the status of receiving phototherapy treatment and the total number of hours of phototherapy treatment during the study will be recorded on this form
Follow-up Form The newborn babys 3-day bilirubin level defecation frequency food intake amount salivary cortisol level abdominal circumference stress and comfort scores will be recorded in this form during the study period
Phototherapy Device Okuman Bilicare-BC 050 000 brand phototherapy device with blue LED technology will be used for phototherapy
Digital Electronic Scale NECK brand EBSH model baby scale 20 kg capacity - 5 g precision will be used to measure the body weight of newborn babies
Camera A camera that can record has high resolution and has high optical focus will be used to evaluate the stress and comfort levels of babies in the intervention and control groups The flash feature of the camera will not be used so that the baby is not disturbed by the camera light
This research was planned to determine the effect of massage on stress behavioral-newborn stress scale and biological-salivary cortisol level comfort Newborn Comfort Behavior Scale and health parameters bilirubin level amount of food intake abdominal distension and defecation frequency of newborns receiving nasal CPAP
Research Type This research is a randomized controlled experimental study
Population and sampleStudy group
The population of the research will consist of newborn babies admitted to the Neonatal Intensive Care Unit of Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital The research sample will consist of newborns who meet the research inclusion criteria In the literature review no study was found that evaluated the effect of massage on babies stress behavioral-newborn stress scale biological-salivary cortisol level comfort and health parameters bilirubin level food intake amount abdominal distension and defecation frequency Asmarani et al 2020 in their study examining the effect of massage on salivary cortisol levels in premature newborns it was determined that they reached 39 19 intervention group 20 control group newborns Asmarani et al 2020 In this study it was decided that the number of newborns in the groups would be 18 based on α 95 confidence level and 80 power The research sample will consist of 36 newborns 18 intervention group 18 control group who meet the research inclusion criteria
Data collection tools
Newborn Information Form Diagnosis of the newborn baby gender type of birth height birth weight gestational and postnatal age Apgar score day of admission and discharge time to start nasal CPAP application total time of receiving nasal CPAP application the status of receiving phototherapy treatment and the total number of hours of phototherapy treatment during the study will be recorded on this form
Follow-up Form The newborn babys 3-day bilirubin level defecation frequency food intake amount salivary cortisol level abdominal circumference stress and comfort scores will be recorded in this form during the study period
Phototherapy Device Okuman Bilicare-BC 050 000 brand phototherapy device with blue LED technology will be used for phototherapy
Digital Electronic Scale NECK brand EBSH model baby scale 20 kg capacity - 5 g precision will be used to measure the body weight of newborn babies
Camera A camera that can record has high resolution and has high optical focus will be used to evaluate the stress and comfort levels of babies in the intervention and control groups The flash feature of the camera will not be used so that the baby is not disturbed by the camera light
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None