- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05287789
Effectiveness of Squatting Position on Constipation Severity and Defecation Problems
Effectiveness of Squatting Position on Constipation Severity and Defecation Problems in the Postoperative Period of Hernia Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Karabük, Turkey
- Karabuk University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hernia surgery in the general surgery clinic
- Between 18 and 65 years of age
- BMI between normal and overweight (18.50-24,99 kg/m2: Normal,25-29,99 kg/m2: Overweight)
- Being able to establish verbal communication
- Volunteering to participate in the study
- Absence of mental confusion
- Having full consciousness and orientation
- Having no communication difficulties
- Having a constipation risk between moderate to high
- Using a water closet type toilet at home
Exclusion Criteria:
- Having a low risk of constipation
- Patient who declined to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Squatting position by footstool
After the first postoperative ambulation, stable patients whose bowel movements resumed met their initial defecation needs with the squatting position created using a footstool at the appropriate height on the water closet type toilet. The patients used footstools in the hospital and throughout a week after discharge at home for defecation. |
Before the study, the height of the toilet bowls in the patient rooms was measured as 42 cm. The stools to be used for the study are manufactured by ordering laminated with white medium density fiberboard and synthetic resin resistant to harsh chemicals. Stools are made of high quality non-slip materials for patient safety. After the first postoperative ambulation, stable patients whose bowel movements resumed met their initial defecation needs with the squatting position created using a stool at the appropriate height on the water closet type toilet. The patients used footstools throughout a week after discharge at home and in the hospital for defecation. |
No Intervention: Control Group
The control group received the routine care provided to all the patients in the clinic with no additional interventions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from before surgery in The Constipation Severity Scale (CSS) average score
Time Frame: Data were collected before surgery, post-op 1st day, post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.
|
Constipation Severity Scale (CSS) aims to determine individuals' defecation frequency, intensity, and difficulty.
The CSS consists of 16 items and three sub dimensions, namely Excrement Congestion, Large Bowel Laziness, and Pain.
The lowest score that can be attained from the CSS is 0 while the highest score that can be attained is 73.
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Data were collected before surgery, post-op 1st day, post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difficulty pushing in defecation average score
Time Frame: Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.
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Average score on a scale from 0 to 4. 0 I did not experience any difficulties, 1 I had mild difficulties, 2 I had some difficulties, 3 I had a lot of difficulties, 4 I experienced extreme difficulties.
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Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.
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Duration of defecation, average minutes
Time Frame: Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.
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The time (minutes) the patient spent defecation.
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Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.
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Defecation pain average score
Time Frame: Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.
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The Visual Analog Scale (VAS) consists of a 10 cm line used to evaluate defecation pain by scoring it between 1 and 10.
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Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.
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Stool consistency
Time Frame: Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.
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Bristol Stool Scale (BSS) is designed to classify the form of human faeces into seven categories.
Types 1-2, hard; types 3-5, normal; types 6-7, loose/liquid
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Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.
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Fear of pushing in defecation average score
Time Frame: Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.
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Average score on a scale from 0 to 4. 0 No Fear, 1 Slightly Scared, 2 Slightly Scared, 3 Very Afraid, 4 Extremely Too Afraid.
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Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Meltem Kaya, Karabuk University
- Study Chair: Aysegul Oksay Sahin, Karabuk University
- Study Chair: Isıl Isık Andsoy, Karabuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SQUATTING
- KBYBAB-17/YL-454 (Other Grant/Funding Number: Karabuk University Scientific Research Projects Office)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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