EFFECT OF ABDOMINAL MASSAGE TRAINING PROVIDED TO CAREGIVERS ON CONSTIPATION MANAGEMENT

NCT07886125 | Recruiting

• 1 other identifier: 2026-2/9
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Constipation is a common and uncomfortable problem among patients receiving palliative care. Alongside usual treatment and nursing care, abdominal massage may help manage constipation. Teaching caregivers how to perform this massage may also help them feel more confident in supporting the patient. This study aims to evaluate the effects of abdominal massage training for caregivers on patients' constipation, caregiver burden, and caregivers' confidence in contributing to patient self-care. Patients and their primary caregivers will participate together. Both patients and caregivers must be aged 18 years or older. Patients must have constipation, have been hospitalized in a palliative care unit for at least two weeks, and have no clinical condition that prevents abdominal massage. Participants will be randomly assigned to one of two groups. Caregivers in the intervention group will receive a single 45-minute training session that includes an explanation and a practical demonstration of abdominal massage. They will also receive a training booklet. After training, caregivers will perform abdominal massage for 15 minutes in the morning and 15 minutes in the evening, three days per week, for two weeks. Patients will continue receiving their usual treatment and care. Patients and caregivers in the control group will continue with usual treatment and care during the study. Control-group caregivers will be offered abdominal massage training after their study participation is completed. Patients' constipation severity and stool form, as well as caregivers' burden and confidence in contributing to patient self-care, will be assessed at the start of the study and on Days 7 and 14. Ethical approval has been obtained from the University of Health Sciences Hamidiye Ethics Committee for Interventional Research Not Involving Drugs or Medical Devices. Institutional permission has been obtained from the study hospital before data collection. Written informed consent has been obtained from patients and caregivers. Participation is voluntary, and personal information will be kept confidential.

Conditions

Constipation

Keywords

constipation; caregiver; palliative care; symptom management

Outcome Measures

Primary Outcomes (3)

• Change in constipation severity measured by the Constipation Assessment Scale

  Constipation severity will be assessed using the Constipation Assessment Scale (CAS). Changes from baseline will be compared between the intervention and control groups.

  Baseline (Day 0), Day 7, and Day 14

• Change in caregiver burden measured by the Zarit Burden Interview

  Caregiver burden will be assessed using the Zarit Burden Interview. Changes in total scores from baseline to follow-up will be compared between caregivers in the intervention and control groups. Lower scores indicate lower caregiver burden.

  Baseline (Day 0), Day 7, and Day 14

• Change in caregiver self-efficacy measured by the Caregiver Self-Efficacy in Contributing to Patient Self-Care Scale (CSE-CSC)

  Caregiver self-efficacy in contributing to patient self-care will be assessed using the CSE-CSC. Changes in total scores from baseline to follow-up will be compared between caregivers in the intervention and control groups. Higher scores indicate greater self-efficacy.

  Baseline (Day 0), Day 7, and Day 14

Secondary Outcomes (1)

• Change in stool form assessed using the Bristol Stool Form Scale (BSFS)

  Baseline (Day 0), Day 7, and Day 14

Study Arms (2)

Caregiver-Delivered Abdominal Massage Group

EXPERIMENTAL

Caregivers receive abdominal massage training and perform abdominal massage on palliative care patients with constipation in addition to routine care.

Behavioral: Caregiver Training in Abdominal Massage

Routine Care Group

NO INTERVENTION

Patients who had routine care without the study-caregiver abdominal massage training or intervention

Interventions

Caregiver Training in Abdominal Massage BEHAVIORAL

Caregivers of palliative care patients with constipation receive training from the researcher on abdominal massage. Following training, caregivers perform abdominal massage on the patients according to the study protocol over a two-week period, in addition to routine care.

Caregiver-Delivered Abdominal Massage Group

Eligibility Criteria

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

You may qualify if:

• Patients:
• Aged 18 years or older.
• Hospitalized in a palliative care unit for at least two weeks.
• Experiencing constipation.
• No clinical contraindication to abdominal massage.
• No open surgical wound, percutaneous endoscopic gastrostomy (PEG), stoma, or active surgical sutures in the abdominal region.
• Caregivers:
• Aged 18 years or older.
• Serving as the patient's primary caregiver.
• No physical or cognitive condition that prevents learning and performing abdominal massage.
• Willing to participate voluntarily in the study.

You may not qualify if:

• Patients:
• Constipation caused by an acute surgical or pathophysiological condition, such as ileus.
• Any clinical condition that makes abdominal massage unsafe.
• Active surgical complications in the abdominal region.
• A clinical condition that prevents completion of the study procedures.
• Caregivers:
• Insufficient cognitive or physical capacity to perform the techniques taught during training.
• A health or social condition that prevents completion of the study procedures.
• Criteria for Discontinuation:
• Participant requests withdrawal from the study.
• Patient is discharged from the hospital.
• Patient dies.
• The data collection process cannot be completed.

Sponsors & Collaborators

• HAMİYET KIZIL: lead

Study Sites (1)

Sultanbeyli State Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hamiyet Kızıl, PhD

CONTACT

+90 (536) 037 07 57; hamiyet.kizil@sbu.edu.tr

Halime Tamince

CONTACT

+90 (506) 124 50 21; halimetmnc99@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A randomized controlled periodic research design will be used in the study. Caregivers meeting the sampling criteria will be divided into groups. Subsequently, experimental and control groups will be randomly assigned using a table of random numbers.

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start: September 9, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)