Gastrointestinal SymptomsNCT07244302
The Effect of Abdominal Massage Applied to Patients by Caregivers in Palliative Care Clinics on Gastrointestinal Symptoms
A study testing Abdominal Massage in people with Gastrointestinal Symptoms, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of abdominal massage applied by caregivers to patients in palliative care clinics on gastrointestinal symptoms. Hypotheses H0a: Abdominal massage applied by caregivers to patients in palliative care clinics has no effect on gastrointestinal symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Symptoms
- What is being tested?
- Abdominal Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2025to 9 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients identified as constipated according to the Rome IV diagnostic criteria, as assessed by a clinical specialist.
- Patients whose hospitalization in the palliative care unit was planned for at least 7 days.
- Patients who were able to receive oral nutrition during the study period.
- Individuals aged 18 years or older.
- Patients who provided written informed consent, or whose first-degree relatives provided consent on their behalf.
- Caregivers responsible for administering the abdominal massage who provided written informed consent to participate in the study.
Who cannot join
- Patients with known gastrointestinal diseases such as ulcerative colitis, Crohn's disease, or irritable bowel syndrome.
- Patients who had received abdominal radiotherapy within the last six weeks or who had undergone abdominal surgery within the past year.
- Patients with acute abdomen, colostomy or ileostomy, significant abdominal distension, abdominal hernia, abdominal tumors, diarrhea, or fecal impaction.
- Patients who were pregnant or suspected of being pregnant.
- Patients receiving enteral nutrition via percutaneous endoscopic gastrostomy (PEG), nasogastric tubes, or similar feeding methods.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik Şehir Hastanesi, Tıbbi Gözlem Kulesi Palyatif Bakım Kliniği
Ankara, 06010
About this study
The aim of this study is to examine the effect of abdominal massage applied by caregivers to patients in palliative care clinics on gastrointestinal symptoms.
Hypotheses H0a: Abdominal massage applied by caregivers to patients in palliative care clinics has no effect on gastrointestinal symptoms.
Read more
H1a: Abdominal massage applied by caregivers to patients in palliative care clinics has an effect on gastrointestinal symptoms.
In this study, the effect of abdominal massage applied to patients following abdominal massage training provided to caregivers in the intervention group will be evaluated by comparing the intervention group, which receives abdominal massage, with the control group, which receives routine care.
Read the detailed description
On the first day of the study, the aim, scope, and procedural steps were thoroughly explained to the patients and their caregivers in both groups, written informed consent was obtained, and baseline assessments were conducted. These assessments included the Individual Descriptive Characteristics Form, Barthel Index of Activities of Daily Living, Defecation Diary, Bristol Stool Form Scale, and the Gastrointestinal Symptom Rating Scale. Subsequently, caregivers in the intervention group received abdominal massage training, and the Abdominal Massage Training Manual prepared by the researchers was provided to support the correct application of the massage techniques.
In the intervention group, patients received abdominal massage administered by their caregivers twice daily for 15 minutes between Days 2 and 7, and each application was recorded on the Abdominal Massage Application Follow-up Form. Patients in the control group continued to receive routine care during the same period. In both groups, Defecation Diary parameters and the Bristol Stool Form Scale were evaluated daily by the researcher between Days 2 and 7.
At the end of Day 7, the Gastrointestinal Symptom Rating Scale was administered again, final assessments were completed, and the study was concluded.
- Conditions
- Gastrointestinal Symptoms
- Being tested
- Abdominal Massage
- Keywords
- Abdominal Massage, Gastrointestinal Symptoms, Palliative Care, Constipation, Caregivers
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal MassageBehavioural
In the intervention group, caregivers received training on abdominal massage, and an Abdominal Massage Training Manual prepared by the researchers was provided to reinforce the education. Following the training, caregivers administered abdominal massage to the patients twice daily for 15 minutes between Days 2 and 7. The massage procedures were performed in accordance with the defined abdominal massage steps, using clockwise movements over the abdominal region, with the aim of reducing gastrointestinal symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Caregivers received training on abdominal massage and applied the massage to patients twice daily for 15 minutes between Days 2 and 7. Each session was recorded on the Abdominal Massage Application Follow-up Form. Receives: Behavioral: Abdominal Massage |
| Control Group | No intervention | Patients in the control group received no additional intervention and continued to receive routine palliative care throughout the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastrointestinal Symptom Severity Assessed by the Gastrointestinal Symptom Rating Scale (GSRS)
The primary outcome of this study is the change in gastrointestinal symptom severity assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a validated and widely used instrument consisting of 15 items organized into five subscales: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item is scored on a 7-point Likert scale (1 = no discomfort, 7 = very severe discomfort), with higher scores indicating more severe symptoms.
The GSRS will be administered at baseline (Day 1) and again at the end of the study period (Day 7). The primary analysis will evaluate the change in the total GSRS score between Day 1 and Day 7 to determine the overall effect of the intervention.
In addition to the total score, all five GSRS subscale scores will be analyzed separately to assess symptom-specific effects of abdominal massage. Between-group comparisons (intervention vs. control) will be conducted to evaluate whether caregiver-administered abdominal massage lead
Measured: Baseline (Day 1) to Day 7
Secondary outcomes (2)
Change in Stool Consistency Assessed by the Bristol Stool Form Scale
Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS) on Day 1 (baseline) and daily from Days 2 to 7. The BSFS classifies stool into seven types ranging from hard and lumpy (Type 1) to completely liquid (Type 7), providing an objective evaluation of stool form.
Daily stool form will be recorded by the researcher, and changes from the baseline (Day 1) measurement across the 7-day follow-up period will be analyzed. Comparisons between the intervention and control groups will be performed to determine whether abdominal massage administered by caregivers influences stool consistency over time.
Measured: Daily assessments from Day 1 (baseline) through Day 7
Change in Bowel Movement Characteristics Assessed by the Defecation Diary
Bowel movement characteristics will be assessed daily using a structured Defecation Diary. The diary includes five parameters:
number of bowel movements, stool amount (1-3 points), stool consistency (1-5 points), straining during defecation (1-4 points), sensation of incomplete evacuation (0-1 points).
Two additional parameters are also recorded daily: laxative/enema use (yes/no), presence of gas/bloating (yes/no). Daily scores from Day 1 to Day 7 will be analyzed to determine changes in bowel function, and comparisons will be made between the intervention and control groups.
Measured: Daily assessments from Day 1 through Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start14 Jul 2025
- Primary completion9 Nov 2025
- Study completion9 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SymptomsStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatma İ Çınar, Prof. Dr., Study director, Gülhane Hemşirelik Fakültesi, Sağlık Bilimleri Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244302
- Sponsor's protocol ID
- AEŞH-EK-2025-153
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study is a single-center academic thesis project and the collected data contain sensitive clinical information that cannot be made publicly available. Data will be used only for the purposes of this research and will not be shared with external investigators.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Massage Applied to Patients by Caregivers in Palliative Care Clinics on Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT07244302
- Acronym / sponsor ID
- AEŞH-EK-2025-153
- Conditions
- Gastrointestinal Symptoms
- Keywords
- Abdominal Massage, Gastrointestinal Symptoms, Palliative Care, Constipation, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 9 Nov 2025 (actual)
- Study completion
- 9 Nov 2025 (actual)
- First posted
- 24 Nov 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 aim of this study is to examine the effect of abdominal massage applied by caregivers to patients in palliative care clinics on gastrointestinal symptoms.
Hypotheses H0a: Abdominal massage applied by caregivers to patients in palliative care clinics has no effect on gastrointestinal symptoms.
H1a: Abdominal massage applied by caregivers to patients in palliative care clinics has an effect on gastrointestinal symptoms.
In this study, the effect of abdominal massage applied to patients following abdominal massage training provided to caregivers in the intervention group will be evaluated by comparing the intervention group, which receives abdominal massage, with the control group, which receives routine care.
Detailed description
On the first day of the study, the aim, scope, and procedural steps were thoroughly explained to the patients and their caregivers in both groups, written informed consent was obtained, and baseline assessments were conducted. These assessments included the Individual Descriptive Characteristics Form, Barthel Index of Activities of Daily Living, Defecation Diary, Bristol Stool Form Scale, and the Gastrointestinal Symptom Rating Scale. Subsequently, caregivers in the intervention group received abdominal massage training, and the Abdominal Massage Training Manual prepared by the researchers was provided to support the correct application of the massage techniques.
In the intervention group, patients received abdominal massage administered by their caregivers twice daily for 15 minutes between Days 2 and 7, and each application was recorded on the Abdominal Massage Application Follow-up Form. Patients in the control group continued to receive routine care during the same period. In both groups, Defecation Diary parameters and the Bristol Stool Form Scale were evaluated daily by the researcher between Days 2 and 7.
At the end of Day 7, the Gastrointestinal Symptom Rating Scale was administered again, final assessments were completed, and the study was concluded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Abdominal MassageCaregivers received training on abdominal massage and applied the massage to patients twice daily for 15 minutes between Days 2 and 7. Each session was recorded on the Abdominal Massage Application Follow-up Form. |
| Control Group | No intervention | –Patients in the control group received no additional intervention and continued to receive routine palliative care throughout the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients identified as constipated according to the Rome IV diagnostic criteria, as assessed by a clinical specialist.
- Patients whose hospitalization in the palliative care unit was planned for at least 7 days.
- Patients who were able to receive oral nutrition during the study period.
- Individuals aged 18 years or older.
- Patients who provided written informed consent, or whose first-degree relatives provided consent on their behalf.
Key exclusion criteria (5 listed)
- Patients with known gastrointestinal diseases such as ulcerative colitis, Crohn's disease, or irritable bowel syndrome.
- Patients who had received abdominal radiotherapy within the last six weeks or who had undergone abdominal surgery within the past year.
- Patients with acute abdomen, colostomy or ileostomy, significant abdominal distension, abdominal hernia, abdominal tumors, diarrhea, or fecal impaction.
- Patients who were pregnant or suspected of being pregnant.
- Patients receiving enteral nutrition via percutaneous endoscopic gastrostomy (PEG), nasogastric tubes, or similar feeding methods.
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 MassageIn the intervention group, caregivers received training on abdominal massage, and an Abdominal Massage Training Manual prepared by the researchers was provided to reinforce the education. Following the training, caregivers administered abdominal massage to the patients twice daily for 15 minutes between Days 2 and 7. The massage procedures were performed in accordance with the defined abdominal massage steps, using clockwise movements over the abdominal region, with the aim of reducing gastrointestinal symptoms. | Behavioural | Intervention Group |
Primary outcome
Change in Gastrointestinal Symptom Severity Assessed by the Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Baseline (Day 1) to Day 7
The primary outcome of this study is the change in gastrointestinal symptom severity assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a validated and widely used instrument consisting of 15 items organized into five subscales: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item is scored on a 7-point Likert scale (1 = no discomfort, 7 = very severe discomfort), with higher scores indicating more severe symptoms. The GSRS will be administered at baseline (Day 1) and again at the end of the study period (Day 7). The primary analysis will evaluate the change in the total GSRS score between Day 1 and Day 7 to determine the overall effect of the intervention. In addition to the total score, all five GSRS subscale scores will be analyzed separately to assess symptom-specific effects of abdominal massage. Between-group comparisons (intervention vs. control) will be conducted to evaluate whether caregiver-administered abdominal massage lead
2 secondary outcomes
Change in Stool Consistency Assessed by the Bristol Stool Form Scale
Time frame: Daily assessments from Day 1 (baseline) through Day 7
Change in Bowel Movement Characteristics Assessed by the Defecation Diary
Time frame: Daily assessments from Day 1 through Day 7
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 24 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study is a single-center academic thesis project and the collected data contain sensitive clinical information that cannot be made publicly available. Data will be used only for the purposes of this research and will not be shared with external investigators.
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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.
Fatma İ Çınar, Prof. Dr. study director
Gülhane Hemşirelik Fakültesi, Sağlık Bilimleri Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Massage in people with Gastrointestinal Symptoms, run by Saglik Bilimleri Universitesi 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 6 inclusion and 5 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 24 Nov 2025. 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 in Gastrointestinal Symptom Severity Assessed by the Gastrointestinal Symptom Rating Scale (GSRS) (time frame: Baseline (Day 1) to Day 7). 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 24 Nov 2025.