ConstipationNCT04373772
Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery
A study testing abdominal massage in people with Constipation and Abdominal Massage, run by Mersin University.
Trial summary
Many factors in patients undergoing cranial surgery (CS) may affect the bowel evacuation of patients, resulting in constipation, which could lead to the use of the valsalva maneuver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Abdominal Massage
- What is being tested?
- abdominal massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 28 Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- volunteered to participate in the study,
- were 18 years old or older and underwent CS,
- stayed in the ICU for ≥ 3 days,
Who cannot join
- have percutaneous endoscopic gastrostomy,
- abdominal hernia,
- irritable bowel syndrome
- bowel cancer,
- history of abdominal surgery,
- pregnancy,
About this study
Official title: The Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery: A Randomized Controlled Trial
Many factors in patients undergoing cranial surgery (CS) may affect the bowel evacuation of patients, resulting in constipation, which could lead to the use of the valsalva maneuver. The aim of this study was to determine the effect of abdominal massage (AM) on bowel evacuation of patients treated in intensive care units (ICU) after CS.
Read the detailed description
The sample of this prospective parallel two-arm randomized controlled trial included 80 patients who underwent CS. The patients were randomly assigned (1:1) to the AM and control groups. The constipation risk of all the patients following CS was assessed with Constipation Risk Assessment Scale (CRAS). Those patients in the AM group received a total of 30 minutes of massage, 15 minutes every morning and evening, until the first defecation. The bowel sounds of all the patients in the AM and control groups were assessed on a daily basis. The days when bowel sounds were heard and the first defecation took place were recorded in a Bowel Evacuation Form.
- Conditions
- Constipation, Abdominal Massage
- Being tested
- abdominal massage
- Keywords
- Cranial surgery, bowel evacuation, constipation, abdominal massage, nursing
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal massageOther
the patients in the AM group were given a total of 30 minutes of AM by the nurses (HD, OM) everyday for 15 minutes in the morning and evening.In this study AM, which included effleurage, strokes, petrissage and vibration techniques, was applied to the patients for 15 minutes in each session at 9:00 am and 9:00 pm.
| Study group | Role | What they receive |
|---|---|---|
| abdominal massage group | Experimental | the abdominal massage group received a total of 30 minutes of massage, 15 minutes every morning and evening, until the first defecation. Receives: Other: abdominal massage |
| control group | No intervention | Routine care for the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primery outcome: bowel sounds
time return of bowel sounds
Measured: up to 10 days
Primery outcome: first defecation
time of the first defecation
Measured: up to 10 days
Secondary outcomes (1)
constipation risk
constipation risk in intensive care unit
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start1 Jul 2015
- Primary completion28 Feb 2016
- Study completion28 Feb 2016
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.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, parallel, two arm (1:1), randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay ALTUN UGRAS, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373772
- Sponsor's protocol ID
- Mersin U
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04373772
- Acronym / sponsor ID
- Mersin U
- Conditions
- Constipation, Abdominal Massage
- Keywords
- Cranial surgery, bowel evacuation, constipation, abdominal massage, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- 28 Feb 2016 (actual)
- First posted
- 4 May 2020 (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.
Many factors in patients undergoing cranial surgery (CS) may affect the bowel evacuation of patients, resulting in constipation, which could lead to the use of the valsalva maneuver. The aim of this study was to determine the effect of abdominal massage (AM) on bowel evacuation of patients treated in intensive care units (ICU) after CS.
Detailed description
The sample of this prospective parallel two-arm randomized controlled trial included 80 patients who underwent CS. The patients were randomly assigned (1:1) to the AM and control groups. The constipation risk of all the patients following CS was assessed with Constipation Risk Assessment Scale (CRAS). Those patients in the AM group received a total of 30 minutes of massage, 15 minutes every morning and evening, until the first defecation. The bowel sounds of all the patients in the AM and control groups were assessed on a daily basis. The days when bowel sounds were heard and the first defecation took place were recorded in a Bowel Evacuation Form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, parallel, two arm (1:1), randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| abdominal massage group | Experimental | Other: abdominal massagethe abdominal massage group received a total of 30 minutes of massage, 15 minutes every morning and evening, until the first defecation. |
| control group | No intervention | –Routine care for the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- volunteered to participate in the study,
- were 18 years old or older and underwent CS,
- stayed in the ICU for ≥ 3 days,
Key exclusion criteria (6 listed)
- have percutaneous endoscopic gastrostomy,
- abdominal hernia,
- irritable bowel syndrome
- bowel cancer,
- history of abdominal surgery,
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 |
|---|---|---|
| abdominal massagethe patients in the AM group were given a total of 30 minutes of AM by the nurses (HD, OM) everyday for 15 minutes in the morning and evening.In this study AM, which included effleurage, strokes, petrissage and vibration techniques, was applied to the patients for 15 minutes in each session at 9:00 am and 9:00 pm. | Other | abdominal massage group |
Primary outcome
Primery outcome: bowel sounds
Time frame: up to 10 days
time return of bowel sounds
Primery outcome: first defecation
Time frame: up to 10 days
time of the first defecation
1 secondary outcome
constipation risk
Time frame: up to 24 hours
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 4 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal massage in people with Constipation and Abdominal Massage, run by Mersin University.
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 3 inclusion and 6 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 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Primery outcome: bowel sounds (time frame: up to 10 days). The study lists 2 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 4 May 2020.