Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446999
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-11
Brief Title:
Yoga-Based Breathing Exercise Colorectal Cancer Surgery
Sponsor:
KTO Karatay University
Organization:
KTO Karatay University
Study Overview
Official Title:
The Effect of Yoga-Based Breathing Exercise on Pain Fatigue Insomnia and Self-Efficacy in Individuals Undergoing Colorectal Cancer Surgery-Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
This study was designed as a prospective parallel two groups and randomized controlled study with an experimental-control group to evaluate the effect of yoga-based breathing exercise on pain fatigue insomnia and self-efficacy in individuals undergoing colorectal cancer surgery The sample size of the study was conducted with 60 patients 30 in the control group and 30 in the experimental group according to the results of a similar study with the GPower 31 97 program with α 005 80 power and 0648 effect and taking into account possible losses was planned Research inclusion criteria Patients who underwent colorectal cancer surgery for the first time were those who were 18 years of age or older had a mobile phone suitable for downloading the yoga-based breathing exercise video used the same type and dose of painkillers and volunteered to participate in the study Personal Information Form VAS Pain Scale Brief Fatigue Inventory Richard Campbell Sleep Scale and Health Promotion Strategies Used by Patients Scale will be used to collect data Participants assigned to the experimental group will be provided with breathing exercises using a protocol containing Yoga-based breathing exercises In order to conduct the research approval will be obtained from KTO Karatay University Non-Drug and Medical Device Research Ethics Committee ethics committee approval and permission will be obtained from the institution where the research will be conducted Participation in the study is voluntary and written consent will be obtained from the participants The data will be evaluated in the IBM SPSS Statistics Standard Concurrent User V 26 IBM Corp Armonk New York USA statistical package program A level of p005 will be considered statistically significant
Detailed Description:
Colorectal cancers are the third most common type of cancer in terms of incidence worldwide and the second leading cause of death Surgical treatment chemotherapy and radiotherapy are generally used in the treatment of colorectal cancers Side effects such as pain nausea-vomiting intestinal problems and fatigue may occur after colorectal cancer surgery CRCS In addition in patients who subsequently receive chemotherapy or radiotherapy these patients may experience symptom distress and their quality of life may be negatively affected due to side effects such as nausea vomiting diarrhea malnutrition peripheral neuropathy and fear of cancer recurrence Pharmacological methods in the management of fatigue are quite limited and the effect of non-pharmacological approaches such as cognitive behavioral therapies relaxation exercise training of patients and their relatives for fatigue management exercise cognitive behavioral therapies and meditation is effective Studies evaluating it are increasing However it has been stated that very few 10 of cancer patients experiencing severe fatigue do yoga to manage fatigue This research was planned to evaluate the effect of yoga-based breathing exercise on pain fatigue insomnia and self-efficacy in individuals undergoing colorectal cancer surgery
Type of Research This study was designed as a prospective parallel 3-group and randomized controlled study with an experimental-control group to evaluate the effect of yoga-based breathing exercise on pain fatigue insomnia and self-efficacy in individuals undergoing colorectal cancer surgery
Place and Time of the Research The research will be conducted at Necmettin Erbakan University Meram Medical Faculty General Surgery Clinic between 01 September 2023 and 30 July 2024
Population and Sample of the Research The research population will consist of patients who come for colorectal cancer surgery between 01 September 2023 and 30 July 2024 at Necmettin Erbakan University Meram Faculty of Medicine General Surgery Clinic where the research will be conducted The sample number of the study was determined according to the results of a similar study with the GPower 31 97 program with α 005 and 80 power and 0648 effect The sample was determined as 50 patients 25 patients in the experimental group and 25 patients in the control group Considering possible losses during the study it was planned to include a total of 60 patients 30 patients in the experimental group and 30 patients in the control group
Data Collection Tools Personal Information Form VAS Pain Scale Brief Fatigue Inventory Richard Campbell Sleep Scale and Health Promotion Strategies Used by Patients Scale will be used to collect data
VAS Pain Scale It is a scale used to evaluate pain by giving a value between 0 and 10 A score of 0 means no pain and a score of 10 means unbearable pain As the score increases the severity of pain increases
Brief Fatigue Inventory The scale evaluates the level of fatigue in the last 24 hours and the reflection of this fatigue on activities in daily life general activity mood walking ability work life relationships with other people joy of life KYE It consists of a total of 9 items 3 items assessing fatigue general fatigue and 6 items assessing the impact of fatigue on daily life Individuals score all items between 0 no fatigue at all and 10 the most severe fatigue you can experience taking into account the last 24 hours
Richard Campbell Sleep Scale The scale developed to determine sleep quality consists of six items depth of night sleep time to fall asleep frequency of waking up time to fall asleep when woken up quality of sleep and noise level in the environment Visual analog scale technique was applied for all expressions RCUÖ average value Scale variables are calculated by adding the mean scores and dividing by five There is only a total score in the scale and the evaluation is made on the average of this score A total score of the scale between 0 and 25 indicates poor sleep and a score between 76 and 100 indicates good sleep An increase in the total score average defines a positive increase in sleep quality
Health Promotion Strategies Used by Patients Scale The health promotion strategies used by patients scale was developed This scale is a 29-item self-report scale The scale which initially consisted of 36 items and 4 subscales was rearranged in 2001 With the factor analysis study called Confirmatory Factor Analysis the number of scale items was reduced to 29 and 3 sub-dimensions were defined These sub-dimensions are coping with stress decision making and positive behavior 1st to 10th of the scale item coping with stress sub-dimension 11th-13th items decision-making sub-dimension 14th-29th The items are the positive behavior subdimension
Implementation of the Research Patients who will undergo CRC will be given verbal information about the research before surgery and those who agree to participate in the research will be evaluated for compliance with the inclusion criteria The purpose of the research and how it will be implemented will be explained to the patient who meets the criteria for inclusion in the research and their written consent will be obtained Initial assessments will be made regarding sociodemographic and health history VAS Pain score Fatigue Insomnia and Self-Efficacy level before surgerypre-intervention After the initial evaluation patients will be assigned according to randomization For the second evaluation the VAS Pain score Fatigue Insomnia and Self-Efficacy levels of the control and experimental groups will be evaluated on the 4th day after surgery
Experimental group A protocol containing yoga-based breathing exercises will be used The audio recording of this breathing exercise protocol will be uploaded to the video After verbal information is given about how to do the exercise the patient will be listened to the audio recording video and will be explained how to do it in practice Then the patient will be placed in a comfortable position by wearing headphones and will be allowed to exercise The patient will be asked to do yoga-based exercise twice a day the night before the surgery once in the morning and once in the evening before going to bed for 3 days after the surgery
Control group Continuity of routine treatment and care of the patients included in the control group will be ensured The control group will be recruited before preoperative assignment to patients After the final test of the patients information will be given about breathing exercises and patients who want to do breathing exercises will be provided with a video link uploaded to their mobile phones
Ethical Dimension of the Research In order to conduct the research ethics committee approval was obtained from KTO Karatay University Non-Pharmaceutical and Non-Medical Device Research Ethics Committee and permission was obtained from the institution where the research will be conducted Participation in the study is voluntary and written consent will be obtained from the participants To avoid bias Clinical Trials protocol registration will be made after obtaining permission from the ethics committee
Statistical Evaluation of Research Data The data will be evaluated in the IBM SPSS Statistics Standard Concurrent User V 26 IBM Corp Armonk New York USA statistical package program Descriptive statistics will be given as number of units n percentage mean standard deviation median M minimum min and maximum max values The normal distribution of the data of numerical variables will be evaluated with the Shapiro Wilk normality test Homogeneity of variances will be evaluated with the Levene test To evaluate the differences between two independent groups Students t Test is used when parametric test prerequisites are met When this could not be achieved the Mann Whitney-U test was used A level of p005 will be considered statistically significant
Type of Research This study was designed as a prospective parallel 3-group and randomized controlled study with an experimental-control group to evaluate the effect of yoga-based breathing exercise on pain fatigue insomnia and self-efficacy in individuals undergoing colorectal cancer surgery
Place and Time of the Research The research will be conducted at Necmettin Erbakan University Meram Medical Faculty General Surgery Clinic between 01 September 2023 and 30 July 2024
Population and Sample of the Research The research population will consist of patients who come for colorectal cancer surgery between 01 September 2023 and 30 July 2024 at Necmettin Erbakan University Meram Faculty of Medicine General Surgery Clinic where the research will be conducted The sample number of the study was determined according to the results of a similar study with the GPower 31 97 program with α 005 and 80 power and 0648 effect The sample was determined as 50 patients 25 patients in the experimental group and 25 patients in the control group Considering possible losses during the study it was planned to include a total of 60 patients 30 patients in the experimental group and 30 patients in the control group
Data Collection Tools Personal Information Form VAS Pain Scale Brief Fatigue Inventory Richard Campbell Sleep Scale and Health Promotion Strategies Used by Patients Scale will be used to collect data
VAS Pain Scale It is a scale used to evaluate pain by giving a value between 0 and 10 A score of 0 means no pain and a score of 10 means unbearable pain As the score increases the severity of pain increases
Brief Fatigue Inventory The scale evaluates the level of fatigue in the last 24 hours and the reflection of this fatigue on activities in daily life general activity mood walking ability work life relationships with other people joy of life KYE It consists of a total of 9 items 3 items assessing fatigue general fatigue and 6 items assessing the impact of fatigue on daily life Individuals score all items between 0 no fatigue at all and 10 the most severe fatigue you can experience taking into account the last 24 hours
Richard Campbell Sleep Scale The scale developed to determine sleep quality consists of six items depth of night sleep time to fall asleep frequency of waking up time to fall asleep when woken up quality of sleep and noise level in the environment Visual analog scale technique was applied for all expressions RCUÖ average value Scale variables are calculated by adding the mean scores and dividing by five There is only a total score in the scale and the evaluation is made on the average of this score A total score of the scale between 0 and 25 indicates poor sleep and a score between 76 and 100 indicates good sleep An increase in the total score average defines a positive increase in sleep quality
Health Promotion Strategies Used by Patients Scale The health promotion strategies used by patients scale was developed This scale is a 29-item self-report scale The scale which initially consisted of 36 items and 4 subscales was rearranged in 2001 With the factor analysis study called Confirmatory Factor Analysis the number of scale items was reduced to 29 and 3 sub-dimensions were defined These sub-dimensions are coping with stress decision making and positive behavior 1st to 10th of the scale item coping with stress sub-dimension 11th-13th items decision-making sub-dimension 14th-29th The items are the positive behavior subdimension
Implementation of the Research Patients who will undergo CRC will be given verbal information about the research before surgery and those who agree to participate in the research will be evaluated for compliance with the inclusion criteria The purpose of the research and how it will be implemented will be explained to the patient who meets the criteria for inclusion in the research and their written consent will be obtained Initial assessments will be made regarding sociodemographic and health history VAS Pain score Fatigue Insomnia and Self-Efficacy level before surgerypre-intervention After the initial evaluation patients will be assigned according to randomization For the second evaluation the VAS Pain score Fatigue Insomnia and Self-Efficacy levels of the control and experimental groups will be evaluated on the 4th day after surgery
Experimental group A protocol containing yoga-based breathing exercises will be used The audio recording of this breathing exercise protocol will be uploaded to the video After verbal information is given about how to do the exercise the patient will be listened to the audio recording video and will be explained how to do it in practice Then the patient will be placed in a comfortable position by wearing headphones and will be allowed to exercise The patient will be asked to do yoga-based exercise twice a day the night before the surgery once in the morning and once in the evening before going to bed for 3 days after the surgery
Control group Continuity of routine treatment and care of the patients included in the control group will be ensured The control group will be recruited before preoperative assignment to patients After the final test of the patients information will be given about breathing exercises and patients who want to do breathing exercises will be provided with a video link uploaded to their mobile phones
Ethical Dimension of the Research In order to conduct the research ethics committee approval was obtained from KTO Karatay University Non-Pharmaceutical and Non-Medical Device Research Ethics Committee and permission was obtained from the institution where the research will be conducted Participation in the study is voluntary and written consent will be obtained from the participants To avoid bias Clinical Trials protocol registration will be made after obtaining permission from the ethics committee
Statistical Evaluation of Research Data The data will be evaluated in the IBM SPSS Statistics Standard Concurrent User V 26 IBM Corp Armonk New York USA statistical package program Descriptive statistics will be given as number of units n percentage mean standard deviation median M minimum min and maximum max values The normal distribution of the data of numerical variables will be evaluated with the Shapiro Wilk normality test Homogeneity of variances will be evaluated with the Levene test To evaluate the differences between two independent groups Students t Test is used when parametric test prerequisites are met When this could not be achieved the Mann Whitney-U test was used A level of p005 will be considered statistically significant
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