Back to resultsEffectiveness of Squatting Position on Constipation Severity and Defecation Problems
Primary Purpose
Constipation, Postoperative Care, Nursing Care
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Squatting position by footstool
Sponsored by
About this trial
This is an interventional supportive care trial for Constipation focused on measuring Squatting Position, Constipation, Defecation problems, Clinical Nursing Research
Eligibility Criteria
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
Sites / Locations
- Karabuk University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Squatting position by footstool
Control Group
Arm Description
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.
The control group received the routine care provided to all the patients in the clinic with no additional interventions.
Outcomes
Primary Outcome Measures
Change from before surgery in The Constipation Severity Scale (CSS) average score
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.
Secondary Outcome Measures
Difficulty pushing in defecation average score
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.
Duration of defecation, average minutes
The time (minutes) the patient spent defecation.
Defecation pain average score
The Visual Analog Scale (VAS) consists of a 10 cm line used to evaluate defecation pain by scoring it between 1 and 10.
Stool consistency
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
Fear of pushing in defecation average score
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05287789
Brief Title
Effectiveness of Squatting Position on Constipation Severity and Defecation Problems
Official Title
Effectiveness of Squatting Position on Constipation Severity and Defecation Problems in the Postoperative Period of Hernia Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Meltem Kaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
One of the most common nursing care problems after surgery is defecation problems and the risk of constipation. The aim of the study was to determine the effectiveness of the squatting position with footstool on the constipation severity and defecation problems in the postoperative period in patients with hernia surgery.
Detailed Description
In this study, after the surgical procedure, the patients were placed in a squatting position by placing a stool under their feet in the toilet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Postoperative Care, Nursing Care
Keywords
Squatting Position, Constipation, Defecation problems, Clinical Nursing Research
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pretest-posttest time series model with the different control group
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Squatting position by footstool
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group received the routine care provided to all the patients in the clinic with no additional interventions.
Intervention Type
Other
Intervention Name(s)
Squatting position by footstool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from before surgery in The Constipation Severity Scale (CSS) average score
Description
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.
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.
Secondary Outcome Measure Information:
Title
Difficulty pushing in defecation average score
Description
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.
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.
Title
Duration of defecation, average minutes
Description
The time (minutes) the patient spent defecation.
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.
Title
Defecation pain average score
Description
The Visual Analog Scale (VAS) consists of a 10 cm line used to evaluate defecation pain by scoring it between 1 and 10.
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.
Title
Stool consistency
Description
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
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.
Title
Fear of pushing in defecation average score
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meltem Kaya
Organizational Affiliation
Karabuk University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aysegul Oksay Sahin
Organizational Affiliation
Karabuk University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Isıl Isık Andsoy
Organizational Affiliation
Karabuk University
Official's Role
Study Chair
Facility Information:
Facility Name
Karabuk University
City
Karabük
Country
Turkey
12. IPD Sharing Statement
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Effectiveness of Squatting Position on Constipation Severity and Defecation Problems
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