StomaNCT04824287
Pelvic Floor Muscle Exercises Effect After Stoma Closure
A study testing pelvic floor muscle exercise in people with Stoma, run by Dilek Aktaş at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effect of pelvic floor muscle exercises on bowel evacuation problems and quality of life in individuals after stoma closure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stoma
- What is being tested?
- pelvic floor muscle exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2018to 5 May 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18 and 75,
- Being literate,
- Having a stoma due to colorectal cancer,
- Having no previous anal trauma,
- Having no anal surgery other than colorectal cancer surgery,
- Having no congenital anorectal anomaly,
Show all 10Show fewer
- Having no neurological problem,
- Having no physical disability,
- Having no previous experience of PFMEs before the surgery,
- Being cognitively able to answer questions
Who cannot join
- Wanting to leave the study,
- Having had previous biofeedback and electrical stimulation therapy applications,
- Having another stoma,
- Not being reachable by phone.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing
Ankara, 06010
About this study
Official title: The Effect of Pelvic Floor Muscle Exercises on Bowel Evacuation Problems and Quality of Life in Individuals With Closed Stoma
This study was conducted to evaluate the effect of pelvic floor muscle exercises on bowel evacuation problems and quality of life in individuals after stoma closure.
Read the detailed description
Sample of study was calculated as 32 using G*Power Software (ver. 3.1.9.2) for 80% power and medium effect size (f=0.25) at 95% confidence level in line with the data of Lin et al. Participants were assigned to the experimental and control groups by the stratified block randomization method. The locks were assigned to layers using Microsoft Excel.
The individuals in the experimental group received pelvic floor muscle exercises training from the researcher using the Roy Adaptation Model in addition to routine discharge training. The patients received a PFME training booklet prepared by the researcher. Face-to-face training was given to the individuals in the experimental group on the day before the operation, on the second and third postoperative days, and on the day of discharge. The training continued with phone calls at the first, second and third weeks and the first, second, third, and sixth months after the surgery. Data was collected a day before discharge, first, second, third, and sixth months after the surgery.
- Conditions
- Stoma
- Being tested
- pelvic floor muscle exercise
- Keywords
- stoma, stoma and wound care nurse, pelvic floor exercises, bowel evacuation problems, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor muscle exerciseOther
pelvic floor muscle exercises training from the researcher using the Roy Adaptation Model in addition to routine discharge training Face-to-face training was given to the individuals in the experimental group on the day before the operation, on the second and third postoperative days, and on the day of discharge. The training continued with phone calls at the first, second and third weeks and the first, second, third, and sixth months after the surgery Patients practiced exercises 6 month after surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | pelvic floor exercise Receives: Other: pelvic floor muscle exercise |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Evacuation Habits
evaluated with "Assessment Form for Bowel Evacuation Habits and Psychosocial Problems". This form was developed by the researcher. Patients answer the question yes or no
Measured: 6 month
Wexner Scale Score
Wexner Scale used to evaluate fecal incontinence. Minimum point is "0" an maximum point is "20". A score of 1 or above indicates a fecal incontinence problem
Measured: 6 month
Psychosocial Problems
evaluated with "Assessment Form for Bowel Evacuation Habits and Psychosocial Problems". This form was developed by the researcher. The form include questions about psychosocial problems related bowel evacuation problems Patient answer the questions yes or no
Measured: 6 month
Health-related Quality of Life
evaluated with Short Form 36 (SF-36) Health-related Quality of Life Scale. This scale include 8 subdimensions. scale does not have a single total score: the score for each dimension is calculated separately. For each subdimension minimum point is 0 and maximum point is 100. Higher score indicate best quality of life
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start10 Dec 2018
- Primary completion5 May 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilek Aktaş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilek Aktaş, Ankara Yildirim Beyazıt University
- Investigators
- Dilek Aktaş, Principal investigator, Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824287
- Sponsor's protocol ID
- 2018/61
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Muscle Exercises on Bowel Evacuation Problems and Quality of Life in Individuals With Closed Stoma
- ClinicalTrials.gov ID
- NCT04824287
- Acronym / sponsor ID
- 2018/61
- Conditions
- Stoma
- Keywords
- stoma, stoma and wound care nurse, pelvic floor exercises, bowel evacuation problems, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dilek AktaşUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 1 Apr 2021 (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.
This study was conducted to evaluate the effect of pelvic floor muscle exercises on bowel evacuation problems and quality of life in individuals after stoma closure.
Detailed description
Sample of study was calculated as 32 using G*Power Software (ver. 3.1.9.2) for 80% power and medium effect size (f=0.25) at 95% confidence level in line with the data of Lin et al. Participants were assigned to the experimental and control groups by the stratified block randomization method. The locks were assigned to layers using Microsoft Excel.
The individuals in the experimental group received pelvic floor muscle exercises training from the researcher using the Roy Adaptation Model in addition to routine discharge training. The patients received a PFME training booklet prepared by the researcher. Face-to-face training was given to the individuals in the experimental group on the day before the operation, on the second and third postoperative days, and on the day of discharge. The training continued with phone calls at the first, second and third weeks and the first, second, third, and sixth months after the surgery. Data was collected a day before discharge, first, second, third, and sixth months after the surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: pelvic floor muscle exercisepelvic floor exercise |
| control group | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Being between the ages of 18 and 75,
- Being literate,
- Having a stoma due to colorectal cancer,
- Having no previous anal trauma,
- Having no anal surgery other than colorectal cancer surgery,
Key exclusion criteria (4 listed)
- Wanting to leave the study,
- Having had previous biofeedback and electrical stimulation therapy applications,
- Having another stoma,
- Not being reachable by phone.
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 |
|---|---|---|
| pelvic floor muscle exercisepelvic floor muscle exercises training from the researcher using the Roy Adaptation Model in addition to routine discharge training Face-to-face training was given to the individuals in the experimental group on the day before the operation, on the second and third postoperative days, and on the day of discharge. The training continued with phone calls at the first, second and third weeks and the first, second, third, and sixth months after the surgery Patients practiced exercises 6 month after surgery | Other | Experimental |
Primary outcome
Bowel Evacuation Habits
Time frame: 6 month
evaluated with "Assessment Form for Bowel Evacuation Habits and Psychosocial Problems". This form was developed by the researcher. Patients answer the question yes or no
Wexner Scale Score
Time frame: 6 month
Wexner Scale used to evaluate fecal incontinence. Minimum point is "0" an maximum point is "20". A score of 1 or above indicates a fecal incontinence problem
Psychosocial Problems
Time frame: 6 month
evaluated with "Assessment Form for Bowel Evacuation Habits and Psychosocial Problems". This form was developed by the researcher. The form include questions about psychosocial problems related bowel evacuation problems Patient answer the questions yes or no
Health-related Quality of Life
Time frame: 6 month
evaluated with Short Form 36 (SF-36) Health-related Quality of Life Scale. This scale include 8 subdimensions. scale does not have a single total score: the score for each dimension is calculated separately. For each subdimension minimum point is 0 and maximum point is 100. Higher score indicate best quality of life
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 1 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Dilek Aktaş principal investigator
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic floor muscle exercise in people with Stoma, run by Dilek Aktaş 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 4 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 1 Apr 2021. 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?
Bowel Evacuation Habits (time frame: 6 month). The study lists 4 primary outcomes in all. 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 1 Apr 2021.