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

NCT ID: NCT07244302

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2025-11-09

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Abdominal Massage

Intervention Type: 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.

Control Group

Patients in the control group received no additional intervention and continued to receive routine palliative care throughout the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Abdominal Massage

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fatma İ Çınar, Prof. Dr.

Role: STUDY_DIRECTOR

Gülhane Hemşirelik Fakültesi, Sağlık Bilimleri Üniversitesi

Locations

Ankara Etlik Şehir Hastanesi, Tıbbi Gözlem Kulesi Palyatif Bakım Kliniği

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AEŞH-EK-2025-153

Identifier Type: -

Identifier Source: org_study_id