The Effect of Abdominal Massage Applied to Patients by Caregivers in Palliative Care Clinics on Gastrointestinal Symptoms

NCT07244302 | Completed

• 1 other identifier: AEŞH-EK-2025-153
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gastrointestinal Symptoms

Keywords

Abdominal Massage; Gastrointestinal Symptoms; Palliative Care; Constipation; Caregivers

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline (Day 1) to Day 7

Secondary Outcomes (2)

• Change in Stool Consistency Assessed by the Bristol Stool Form Scale

  Daily assessments from Day 1 (baseline) through Day 7

• Change in Bowel Movement Characteristics Assessed by the Defecation Diary

  Daily assessments from Day 1 through Day 7

Other Outcomes (2)

• Baseline Functional Independence Assessed by the Barthel Index

  Day 1 (Baseline only)

• Baseline Descriptive and Demographic Characteristics

  Day 1 (Baseline only)

Study Arms (2)

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.

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.

Interventions

Abdominal Massage BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Ankara Etlik Şehir Hastanesi, Tıbbi Gözlem Kulesi Palyatif Bakım Kliniği

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatma İ Çınar, Prof. Dr.

  Gülhane Hemşirelik Fakültesi, Sağlık Bilimleri Üniversitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: July 14, 2025
• Primary Completion: November 9, 2025
• Study Completion: November 9, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)