Subarachnoid Haemorrhage (SAH)MassageNCT06824857
Effect of Abdominal Massage on Bowel Movements in Patients With Subarachnoid Hemorrhage
A study testing Abdominal Massage Application in people with Subarachnoid Haemorrhage (SAH), run by Gazi University at 2 sites in Turkey (Türkiye).
Trial summary
The study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Subarachnoid Haemorrhage (SAH)
- What is being tested?
- Abdominal Massage Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 16 Sep 2024to 20 Mar 2025
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 18 years of age or older
- Underwent neurovascular surgery
- Received general anesthesia
- Have no wounds, surgical intervention, or radiotherapy in the abdominal region
- Have no bowel obstruction, irritable bowel syndrome, inflammatory bowel disease, abdominal herniation, or bowel cancer
- Began oral feeding at the 6th hour post-surgery
Show all 15Show fewer
- Stayed in the intensive care unit for 3 or more days
- Have a Glasgow Coma Scale (GCS) score of 9 or above
- Have no signs of acute abdomen
- Have no intra-abdominal infection
- No mechanical ventilation
- Mobilezed in the preoperative period
- Unable to mobilize after surgery
- Evaluated by the intensive care physician with no contraindications for abdominal massage
- Have a first-degree relative who has given consent
Who cannot join
- Patients with the following conditions will be excluded from the sample:
- Those with chronic constipation, fecal incontinence, or diarrhea
- Those fed with a fiber-enriched nutritional solution (e.g., Nutrison Protein Plus Multifibre®, Fresubin Original Fibre®, Isosource Fiber®, Jevity Plus®)
- Those fed via nasogastric enteral tube
- Those receiving parenteral nutrition
- Patients with a BMI > 40 (morbid obesity)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Faculty of Nursing, Gazi University
Ankara, 06490
Gazi University
Ankara
About this study
Official title: Effect of Postoperative Abdominal Massage on Bowel Movements in Patients With Subarachnoid Hemorrhage
The study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit.
Read the detailed description
The study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit. The sample of the study will consist of a total of 64 patients, 32 in the experimental group and 32 in the control group, hospitalized in the tertiary neurosurgery intensive care unit. Data collection tools are the "Descriptive Characteristics Form" and the "Patient Follow-up Form".The statistician will determine whether the patients who meet the sampling criteria will be assigned to the experimental or control group through randomization. The stratified randomization method will be used in the study. In this context, patients who meet the inclusion criteria from the start date of the study in the Neurosurgery Intensive Care Unit will be randomized by assigning them to the control group and abdominal massage groups, respectively. Patients will be assigned to the control and abdominal massage groups in this order until the sample size is reached. The CONSORT diagram will be used in the randomization of patients.
- Conditions
- Subarachnoid Haemorrhage (SAH)
- Being tested
- Abdominal Massage Application
- Keywords
- subarachnoid hemorrhage, Abdominal massage, bowel movements, nursing
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Massage ApplicationOther
As part of the abdominal massage application, patient follow-up forms and checklists were prepared. Before starting the study, the abdominal massage practitioner participated in a certification program on this topic and received a competency certificate. Patients will be followed up for the first 3 days postoperatively using the prepared patient follow-up forms. Abdominal massage will be applied to each patient for 15 minutes according to a certain standard as stated in the literature
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Massage Application Group | Experimental | After explaining the purpose of the study to the relatives of patients in the abdominal massage group, the "Introductory Characteristics Form" will be filled out. Abdominal massage will be performed according to the Checklist at the 6th hour after surgery and at the same times in the morning and evening for the first 3 days post-surgery. Before and 15 minutes after the abdominal massage application, bowel sounds will be auscultated, abdominal circumference will be measured with a measuring tape, and abdominal tension will be observed and recorded in the patient follow-up form. Receives: Other: Abdominal Massage Application |
| Control Group | No intervention | After explaining the purpose of the study to the relatives of patients in the control group, the "Introductory Characteristics Form" will be filled out. At the same times as the experimental group, bowel sounds will be auscultated in the control group without any intervention, abdominal circumference will be measured with a measuring tape, and abdominal tension will be observed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Defecate
Time of first defecation
Measured: From the 6th hour after surgery until the end of the 3rd day after surgery
Bowel Sounds
Frequency of bowel sounds heard per minute
Measured: From the 6th hour after surgery until the end of the 3rd day after surgery
Abdominal Distension
To be assessed by measuring the abdominal circumference with a tape measure
Measured: From the 6th hour after surgery until the end of the 3rd day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start16 Sep 2024
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Haemorrhage (SAH)Studies of the same condition, open and under way.
- More trials run by Gazi 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
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zühal Erdoğan, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824857
- Sponsor's protocol ID
- 2024 - 306
- Acronym
- Massage
- Status last verified
- Aug 2025
- First submitted
- 11 Oct 2024
- Last updated
- 21 Aug 2025
- 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 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postoperative Abdominal Massage on Bowel Movements in Patients With Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT06824857
- Acronym / sponsor ID
- Massage / 2024 - 306
- Conditions
- Subarachnoid Haemorrhage (SAH)
- Keywords
- subarachnoid hemorrhage, Abdominal massage, bowel movements, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 13 Feb 2025 (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.
The study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit.
Detailed description
The study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit. The sample of the study will consist of a total of 64 patients, 32 in the experimental group and 32 in the control group, hospitalized in the tertiary neurosurgery intensive care unit. Data collection tools are the "Descriptive Characteristics Form" and the "Patient Follow-up Form".The statistician will determine whether the patients who meet the sampling criteria will be assigned to the experimental or control group through randomization. The stratified randomization method will be used in the study. In this context, patients who meet the inclusion criteria from the start date of the study in the Neurosurgery Intensive Care Unit will be randomized by assigning them to the control group and abdominal massage groups, respectively. Patients will be assigned to the control and abdominal massage groups in this order until the sample size is reached. The CONSORT diagram will be used in the randomization of patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal Massage Application Group | Experimental | Other: Abdominal Massage ApplicationAfter explaining the purpose of the study to the relatives of patients in the abdominal massage group, the "Introductory Characteristics Form" will be filled out. Abdominal massage will be performed according to the Checklist at the 6th hour after surgery and at the same times in the morning and evening for the first 3 days post-surgery. Before and 15 minutes after the abdominal massage application, bowel sounds will be auscultated, abdominal circumference will be measured with a measuring tape, and abdominal tension will be observed and recorded in the patient follow-up form. |
| Control Group | No intervention | –After explaining the purpose of the study to the relatives of patients in the control group, the "Introductory Characteristics Form" will be filled out. At the same times as the experimental group, bowel sounds will be auscultated in the control group without any intervention, abdominal circumference will be measured with a measuring tape, and abdominal tension will be observed |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- • 18 years of age or older
Key exclusion criteria (6 listed)
- Patients with the following conditions will be excluded from the sample:
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 Massage ApplicationAs part of the abdominal massage application, patient follow-up forms and checklists were prepared. Before starting the study, the abdominal massage practitioner participated in a certification program on this topic and received a competency certificate. Patients will be followed up for the first 3 days postoperatively using the prepared patient follow-up forms. Abdominal massage will be applied to each patient for 15 minutes according to a certain standard as stated in the literature | Other | Abdominal Massage Application Group |
Primary outcome
Time To Defecate
Time frame: From the 6th hour after surgery until the end of the 3rd day after surgery
Time of first defecation
Bowel Sounds
Time frame: From the 6th hour after surgery until the end of the 3rd day after surgery
Frequency of bowel sounds heard per minute
Abdominal Distension
Time frame: From the 6th hour after surgery until the end of the 3rd day after surgery
To be assessed by measuring the abdominal circumference with a tape measure
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 21 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Massage Application in people with Subarachnoid Haemorrhage (SAH), run by Gazi University at 2 sites 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 15 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 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Time To Defecate (time frame: From the 6th hour after surgery until the end of the 3rd day after surgery). The study lists 3 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 21 Aug 2025.