An interventional study of Caregiver Training in Abdominal Massage in Constipation, sponsored by HAMİYET KIZIL. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by HAMİYET KIZIL · Not applicable, Interventional, and Supportive care
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.
Constipation is an important symptom management concern in palliative care. Patients may experience constipation in association with their underlying illnesses, medication use, reduced mobility, and changes in food and fluid intake. Individualized nursing assessment and care are therefore important components of constipation management.
Abdominal massage is a nonpharmacological approach that may complement routine constipation management. Training primary caregivers to perform abdominal massage may support their active participation in care. This randomized controlled study aims to evaluate the effects of caregiver abdominal massage training and caregiver-delivered abdominal massage on constipation severity and stool form in palliative care patients, and on caregiver burden and self-efficacy in contributing to patient self-care.
The study will use a randomized controlled experimental design and will be conducted in the palliative care unit of Sultanbeyli State Hospital in Istanbul, Türkiye. Eligible patients and their primary caregivers will participate as patient-caregiver pairs. Pairs will be randomly assigned to the intervention or control group using a random number table.
Researcher Preparation and Baseline Assessment Before delivering the intervention, the researcher will complete certified abdominal massage training. The researcher will be present in the palliative care unit during study procedures to maintain communication with caregivers and support accurate completion of the data collection instruments.
After informed consent, caregivers in both groups will complete a structured information form. Baseline assessments will include the Constipation Assessment Scale (CAS) and Bristol Stool Form Scale (BSFS) for patients, and the Zarit Burden Interview and Caregiver Self-Efficacy in Contributing to Patient Self-Care Scale (CSE-CSC) for caregivers. Completion of the data collection instruments is expected to take approximately 20 minutes.
Intervention Group Caregivers will receive one 45-minute abdominal massage training session, consisting of theoretical instruction followed by practical demonstration. The training will cover four topics: the role and importance of abdominal massage in constipation management in palliative care; its relevance to caregivers; the potential effects of abdominal massage; and the steps of the massage procedure. A training booklet will be provided at the end of the session.
Following training, caregivers will perform abdominal massage on the patient over a two-week period. Massage will be performed three days per week, twice on each scheduled day, for 15 minutes in the morning and 15 minutes in the evening. Sessions will be scheduled to avoid interference with treatment times and routine clinical activities. Baby oil will be used as a lubricant during massage. Routine treatment and nursing care will continue throughout the study.
Control Group Patients in the control group will receive routine treatment and nursing care without the study-specific abdominal massage intervention during the two-week follow-up period. After completion of study procedures, control-group caregivers will be offered abdominal massage training.
Outcome Assessment Assessments will be repeated in both groups on Days 7 and 14. Patient outcomes will include constipation severity assessed using the CAS and stool form assessed using the BSFS. Caregiver outcomes will include caregiver burden assessed using the Zarit Burden Interview and self-efficacy in contributing to patient self-care assessed using the CSE-CSC. Changes from baseline will be compared between the intervention and control groups.
Discontinuation Criteria Study participation will be discontinued if a participant requests withdrawal, the patient is discharged from hospital, the patient dies, or the data collection process cannot be completed.
Ethical Considerations 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 begins.
Eligible patients and caregivers will be informed about the study purpose, procedures, voluntary participation, confidentiality, and protection of privacy. Written informed consent will be obtained from patients and caregivers before study procedures. Personal information will be kept confidential, and participants' privacy will be protected throughout the research.
1,040 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's planned enrollment of 62 is below the median of 78 across 867 interventional studies indexed under Constipation.
Browse Constipation studies →This is the only study on the registry with HAMİYET KIZIL as lead sponsor.
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Patients:
Caregivers:
Exclusion Criteria:
Patients:
Caregivers:
Criteria for Discontinuation:
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
Patients who had routine care without the study-caregiver abdominal massage training or intervention
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 0), Day 7, and Day 14
Change in stool form assessed using the Bristol Stool Form Scale (BSFS)
Stool form will be assessed using the Bristol Stool Form Scale (BSFS), which classifies stools into seven types, from hard lumps (Type 1) to entirely liquid stools (Type 7). Types 1 and 2 indicate constipation-associated stool forms, while Types 3 and 4 indicate generally normal stool forms. Changes in stool type over time will be compared between the intervention and control groups.
Time frame: Baseline (Day 0), Day 7, and Day 14
Plan to share: No — There is currently no plan to share individual participant data from this study. Study findings will be disseminated through the master's thesis and scientific publications using aggregate results.
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