NCT07402785

Brief Summary

This study aimed to determine the effect of abdominal massage on constipation in patients undergoing hemodialysis. The main questions he intends to answer are: H0: Abdominal massage applied to patients undergoing hemodialysis treatment has no effect on constipation. H1: Abdominal massage applied to patients receiving hemodialysis treatment has an effect on constipation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

18 days

First QC Date

January 28, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

abdominal massage

Outcome Measures

Primary Outcomes (1)

  • Constipation Severity

    change in constipation severity measured using the Constipation Severity Scale

    baseline and end of week 6

Secondary Outcomes (2)

  • Constipation-related Quality of Life

    Baseline and end of week 6

  • Stool Consistency

    Baseline and end of week 6

Study Arms (2)

control group (n = 25)

NO INTERVENTION

The control group did not receive abdominal massage and continued their routine treatment. In groups, outcome measures were assessed at baseline (first week) and at the end of the study period (sixth week). For evaluation Bristol Stool Form Scale, Constipation Severity Scale, and Constipation Quality of Life Questionnaire, administered face-to-face by the researcher.

intervention group (n = 24)

EXPERIMENTAL

One patient in the intervention group died one month after the initiation of the study, and the intervention was discontinued for this patient.Abdominal massage was administered to the intervention group during hemodialysis sessions in the dialysis units of the respective hospitals, without interrupting the treatment process. Patient privacy was ensured using a curtain before each session. Massage was applied at least 30 minutes after meals. Before each session, patients' general physical and mental condition, vital signs, abdominal tension/sensitivity, and skin integrity were assessed. Abdominal massage was performed by the researcher twice weekly for six weeks, with each session lasting 15 minutes, for a total of 12 sessions. At the end of the sixth week, the effectiveness of the intervention was evaluated using the Bristol Stool Form Scale, Constipation Severity Scale, and Constipation Quality of Life Questionnaire, administered face-to-face by the researcher.

Other: abdominal massage

Interventions

Abdominal massage is considered a promising complementary approach for alleviating the symptoms of chronic constipation due to its noninvasive nature and relatively low cost. This intervention is thought to stimulate somato-autonomic reflexes and intestinal motility, thereby enhancing peristalsis and promoting contractions of the rectal muscles. Through massage application, bowel movements become more active. In addition, abdominal massage exerts effects on the abdominal muscles and the large intestine, and by stimulating the abdominal nerve plexus (splanchnic plexus), it alters intestinal tone. As a result of these mechanisms, constipation-related symptoms such as pain and discomfort are reduced.

intervention group (n = 24)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Voluntarily agreed to participate in the study
  • Receiving hemodialysis treatment for at least one month
  • Diagnosed with constipation by a clinician or meeting Rome IV criteria
  • Able to communicate effectively and respond to all study-related questions, either personally or through a caregiver

You may not qualify if:

  • History of ileus or intestinal perforation
  • Presence of abdominal distension
  • Presence of a colostomy or ileostomy
  • Presence of extensive abdominal skin disease or infection
  • Diagnosis of inflammatory bowel disease
  • Presence of signs or symptoms of an acute abdomen
  • Presence of diarrhea
  • Known allergy to baby oil
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Trabzon, Trabzon, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study was designed as a randomized controlled clinical trial with an experimental, pretest-posttest design.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
NURSE

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 11, 2026

Study Start

June 2, 2025

Primary Completion

June 20, 2025

Study Completion

August 9, 2025

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Confidentiality of the study Participant confidentiality was strictly maintained throughout the study. All personal and clinical data were anonymized by assigning unique identification codes to each participant, and no identifying information was included in the data collection forms or analysis. Study data were accessible only to the research team and were stored securely in accordance with institutional and ethical guidelines. The results were reported in aggregate form to ensure that individual participants could not be identified.

Locations