Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290830
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-26
Brief Title:
Abdominal Massage and Kegel Exercises on Constipation and Quality of Life in Female Students
Sponsor:
Ondokuz Mayıs University
Organization:
Ondokuz Mayıs University
Study Overview
Official Title:
The Effect of Abdominal Massage and Kegel Exercises on Constipation and Quality of Life in Female Students With Functional Constipation A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
In this prospective randomized controlled study n140 female students with functional constipation studying at two universities Faculty of Health Sciences and meeting the Rome-IV Diagnostic Criteria for Constipation will be included in the study Between 15032024 and 31052024 n140 35control group 35kegel exercise group 35abdominal exercise group 35abdominal and kegel exercise group volunteered to participate in the study Female students with functional constipation will be randomly divided into four groups as intervention and control groups Personal Information Form Bristol Stool Scale Constipation Severity Scale and Patient Assessment of Constipation Quality of Life Questionnaire will be used in this study The scales will be used in the research two times pre and post-test scales were reassessed at the end of the study after the exercise intervention Descriptive statistics Pearson and Spearmans correlation analyses will be used in the analysis of research data
Detailed Description:
This study aimed to investigate the effect of abdominal massage and kegel exercises on constipation and quality of life in female students with functional constipation
Type of Research This study was conducted in a prospective four-arm and randomized controlled manner
Female students with functional constipation studying at two universities Faculty of Health Sciences and meeting the Rome-IV Diagnostic Criteria for Constipation will be included in the study
The power analysis of this study was performed with GPOWER 3197 Power analysis statistical software The sample size of the study was based on the average score of the Patient Assessment of Constipation Quality of Life Questionnaire Patient Assessment of Constipation Quality of Life Questionnaire It was determined that 31 individuals from each group would be sufficient to participate in the study with an effect size of 064 α 005 margin of error and minimum power 80 β 02 Considering the possible missing data it was calculated that each group should consist of 35 female students with functional constipation with a 10 increase
Data Collection Tools-Validity and Reliability Information In the study the Personal Information Form Bristol Stool Scale Constipation Severity Scale and Patient Assessment of Constipation Quality of Life Questionnaire will be used The scales will be used in the research two times pre and post-test scales were reassessed at the end of the study after the exercise intervention
Personal Information Form The information form developed by the researchers by analyzing the literature consisted of 10 questions about sociodemographic characteristics health status and variables affecting constipation
Bristol Stool Scale The type of stool is classified into 7 different groups In the Bristol Stool Scale the transit time of the stool through the intestine is evaluated over seven different stool types According to Bristol Stool Scale 1-2 points are shown as hard stool 3-4-5 points as normal stool and 6-7 points as soft-watery stool diarrhea
Constipation Severity Scale It is a scale for determining the frequency intensity and difficultydifficulty during defecation In addition it was aimed to measure the constipation symptoms of the participants through this scale There are 16 questions on the scale The scale has three sub-dimensions fecal obstruction large bowel laziness and pain The score that can be obtained from the Faecal Obstruction sub-dimension is 0-28 the score that can be obtained from the Large Bowel sub-dimension is 0-29 and the score that can be obtained from the Pain sub-dimension is 0-16 The lowest total score that can be obtained from this scale is 0 and the highest score is 73 A high score on the scale indicates that the symptoms are serious Internal consistency α 088-091 and test-retest reliability intraclass correlation coefficients 084-091 were reported to be high for all subscales
Patient Assessment of Constipation Quality of Life Questionnaire This scale measures the quality of life in constipation This is a 28-item self-assessment scale consisting of WorryAnxiety 11 items Physical Discomfort 4 items Psychosocial Discomfort 8 items and Satisfaction 5 items subscales The item scores of the five-point Likert-type scale vary between 1-5 The highest score obtained from the scale is 140 and the lowest score is 28 It is thought that quality of life is negatively affected as the scores obtained from the scale increase The Cronbach alpha reliability coefficient of the scale is 091 The Cronbach alpha reliability coefficient of the Physical Discomfort subscale is 088 the total item correlation coefficient is 091 the Cronbach alpha reliability coefficient of the Psychosocial Discomfort subscale is 087 the total item correlation coefficient is 0 82 Cronbach alpha reliability coefficient of Worry and Anxiety subscale was 085 the total item correlation coefficient was 084 and Cronbach alpha reliability coefficient of Satisfaction subscale was 076 total item correlation coefficient was 080
The female students included in the study will be taught abdominal massage and kegel exercises by the researcher in an appropriate environment according to the interventional group determined as a result of the randomization assignment The intervention and control groups will be initially trained on nutrition in constipation
Abdominal massage group 35 students Abdominal massage is demonstrated by the researchers to a female student with functional constipation The student will apply exfoliation superficial and deep petrissage and vibration massage movements for about 15 minutes twice a day in the morning and evening hours and at least 30 minutes after the nutritional meal 5 days a week for a total of 12 weeks
Kegel exercise group 35 students 2 times a day in the morning and evening hours 5 days a week for a total of 12 weeks
Abdominal massage and kegel exercise group 35 students students will do both abdominal and kegel exercises for 12 weeks
Control group 35 students No intervention will be made to the control group
Ethical Aspects of the Research For the ethical suitability of the research The University Rectorate Ethical approval was obtained at the meeting of the Social and Human Sciences Ethics Committee dated 30012024 and numbered 2023-0844 and written permission was obtained from two universities for data collection Written informed consent is also obtained from the participating students The research was conducted following the rules of the Declaration of Helsinki
Type of Research This study was conducted in a prospective four-arm and randomized controlled manner
Female students with functional constipation studying at two universities Faculty of Health Sciences and meeting the Rome-IV Diagnostic Criteria for Constipation will be included in the study
The power analysis of this study was performed with GPOWER 3197 Power analysis statistical software The sample size of the study was based on the average score of the Patient Assessment of Constipation Quality of Life Questionnaire Patient Assessment of Constipation Quality of Life Questionnaire It was determined that 31 individuals from each group would be sufficient to participate in the study with an effect size of 064 α 005 margin of error and minimum power 80 β 02 Considering the possible missing data it was calculated that each group should consist of 35 female students with functional constipation with a 10 increase
Data Collection Tools-Validity and Reliability Information In the study the Personal Information Form Bristol Stool Scale Constipation Severity Scale and Patient Assessment of Constipation Quality of Life Questionnaire will be used The scales will be used in the research two times pre and post-test scales were reassessed at the end of the study after the exercise intervention
Personal Information Form The information form developed by the researchers by analyzing the literature consisted of 10 questions about sociodemographic characteristics health status and variables affecting constipation
Bristol Stool Scale The type of stool is classified into 7 different groups In the Bristol Stool Scale the transit time of the stool through the intestine is evaluated over seven different stool types According to Bristol Stool Scale 1-2 points are shown as hard stool 3-4-5 points as normal stool and 6-7 points as soft-watery stool diarrhea
Constipation Severity Scale It is a scale for determining the frequency intensity and difficultydifficulty during defecation In addition it was aimed to measure the constipation symptoms of the participants through this scale There are 16 questions on the scale The scale has three sub-dimensions fecal obstruction large bowel laziness and pain The score that can be obtained from the Faecal Obstruction sub-dimension is 0-28 the score that can be obtained from the Large Bowel sub-dimension is 0-29 and the score that can be obtained from the Pain sub-dimension is 0-16 The lowest total score that can be obtained from this scale is 0 and the highest score is 73 A high score on the scale indicates that the symptoms are serious Internal consistency α 088-091 and test-retest reliability intraclass correlation coefficients 084-091 were reported to be high for all subscales
Patient Assessment of Constipation Quality of Life Questionnaire This scale measures the quality of life in constipation This is a 28-item self-assessment scale consisting of WorryAnxiety 11 items Physical Discomfort 4 items Psychosocial Discomfort 8 items and Satisfaction 5 items subscales The item scores of the five-point Likert-type scale vary between 1-5 The highest score obtained from the scale is 140 and the lowest score is 28 It is thought that quality of life is negatively affected as the scores obtained from the scale increase The Cronbach alpha reliability coefficient of the scale is 091 The Cronbach alpha reliability coefficient of the Physical Discomfort subscale is 088 the total item correlation coefficient is 091 the Cronbach alpha reliability coefficient of the Psychosocial Discomfort subscale is 087 the total item correlation coefficient is 0 82 Cronbach alpha reliability coefficient of Worry and Anxiety subscale was 085 the total item correlation coefficient was 084 and Cronbach alpha reliability coefficient of Satisfaction subscale was 076 total item correlation coefficient was 080
The female students included in the study will be taught abdominal massage and kegel exercises by the researcher in an appropriate environment according to the interventional group determined as a result of the randomization assignment The intervention and control groups will be initially trained on nutrition in constipation
Abdominal massage group 35 students Abdominal massage is demonstrated by the researchers to a female student with functional constipation The student will apply exfoliation superficial and deep petrissage and vibration massage movements for about 15 minutes twice a day in the morning and evening hours and at least 30 minutes after the nutritional meal 5 days a week for a total of 12 weeks
Kegel exercise group 35 students 2 times a day in the morning and evening hours 5 days a week for a total of 12 weeks
Abdominal massage and kegel exercise group 35 students students will do both abdominal and kegel exercises for 12 weeks
Control group 35 students No intervention will be made to the control group
Ethical Aspects of the Research For the ethical suitability of the research The University Rectorate Ethical approval was obtained at the meeting of the Social and Human Sciences Ethics Committee dated 30012024 and numbered 2023-0844 and written permission was obtained from two universities for data collection Written informed consent is also obtained from the participating students The research was conducted following the rules of the Declaration of Helsinki
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