ConstipationNCT05287789
Effectiveness of Squatting Position on Constipation Severity and Defecation Problems
A study testing Squatting position by footstool in people with Constipation and Postoperative Care, run by Meltem Kaya at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Constipation, Postoperative Care, Nursing Care
- What is being tested?
- Squatting position by footstool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Having a low risk of constipation
- Patient who declined to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Squatting Position on Constipation Severity and Defecation Problems in the Postoperative Period of Hernia Surgery
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.
Read the 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.
- Conditions
- Constipation, Postoperative Care, Nursing Care
- Being tested
- Squatting position by footstool
- Keywords
- Squatting Position, Constipation, Defecation problems, Clinical Nursing Research
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Squatting position by footstoolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Squatting position by footstool | Experimental | 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. Receives: Other: Squatting position by footstool |
| Control Group | No intervention | The control group received the routine care provided to all the patients in the clinic with no additional interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (5)
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.
Measured: 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.
Duration of defecation, average minutes
The time (minutes) the patient spent defecation.
Measured: 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.
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.
Measured: 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.
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
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Jan 2018
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- pretest-posttest time series model with the different control group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meltem Kaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meltem Kaya, Karabuk University
- Investigators
- Meltem Kaya, Principal investigator, Karabuk UniversityAysegul Oksay Sahin, Study chair, Karabuk UniversityIsıl Isık Andsoy, Study chair, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287789
- Sponsor's protocol ID
- SQUATTING
- Other IDs
- KBYBAB-17/YL-454
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Squatting Position on Constipation Severity and Defecation Problems in the Postoperative Period of Hernia Surgery
- ClinicalTrials.gov ID
- NCT05287789
- Acronym / sponsor ID
- SQUATTING
- Conditions
- Constipation, Postoperative Care, Nursing Care
- Keywords
- Squatting Position, Constipation, Defecation problems, Clinical Nursing Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Meltem KayaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- pretest-posttest time series model with the different control group
| Arm | Type | Receives |
|---|---|---|
| Squatting position by footstool | Experimental | Other: Squatting position by footstoolAfter 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. |
| Control Group | No intervention | –The control group received the routine care provided to all the patients in the clinic with no additional interventions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- Having a low risk of constipation
- Patient who declined to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Squatting position by footstoolBefore 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. | Other | Squatting position by footstool |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
Related trials for Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effect of a Constipation Prevention Checklist in Hip Surgery Patients
Constipation, Perioperative Nursing
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meltem Kaya principal investigator
Karabuk University
Aysegul Oksay Sahin study chair
Karabuk University
Isıl Isık Andsoy study chair
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Squatting position by footstool in people with Constipation and Postoperative Care, run by Meltem Kaya at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.