NCT07208955

Brief Summary

This randomised controlled trial was designed to determine the effect of early-stage heat application and abdominal massage on patients' gastrointestinal function and mental well-being following hip fracture surgery. The study's hypotheses are as follows: H0: Heat application and abdominal massage administered in the early postoperative period have no effect on gastrointestinal function or mental well-being. H1: Heat application in the early postoperative period affects gastrointestinal function and mental well-being. H2: Abdominal massage administered in the early postoperative period has an effect on gastrointestinal function and mental well-being. The Patient Information Form, Gastrointestinal Symptom Rating Scale (GSRS) and Warwick-Edinburgh Mental Well-being Scale will be administered. Starting from the morning of the first day after surgery, patients will receive abdominal massage and heat application twice daily, in the morning and evening, for three days. The warm compress and abdominal massage will be performed consecutively. The total application time will be 30 minutes, consisting of 15 minutes of warm compress and 15 minutes of abdominal massage. Abdominal massage will be performed on patients in the experimental group using the 'abdominal massage application guidelines'. Abdominal massage involves techniques such as effleurage (stroking and spreading), petrissage (kneading) and vibration. After each application of massage, the patient's bowel sounds and movements will be listened to using a stethoscope. Before applying heat and performing the abdominal massage, care will be taken to ensure that the patient does not need to urinate, and that the room is quiet and at a suitable temperature. Patients in the experimental group will not be given laxatives, suppositories or enemas for three days; only heat application and massage will be performed during this period. During this period, researchers will assess the defecation of patients using the Bristol Stool Scale. At the end of the three-day follow-up period, patients will be asked to complete the Bristol Stool Scale, the Gastrointestinal Symptom Rating Scale and the Warwick-Edinburgh Mental Well-being Scale.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

February 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

September 9, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

abdominal massagegastrointestinal functionmental well-being

Outcome Measures

Primary Outcomes (2)

  • abdominal massage

    Assessment of bowel sounds, first flatus and time of defecation.

    30 minutes

  • heat application

    Assessment of bowel sounds using a stethoscope

    30 minutes

Study Arms (3)

Heat application group

EXPERIMENTAL

The experimental group will receive heat application

Procedure: heat application

Massage group

EXPERIMENTAL

The massage group will receive abdominal massage.

Procedure: abdominal massage

placebo group

PLACEBO COMPARATOR

No intervention will be performed on the placebo group.

Other: control group

Interventions

Heat application in the early postoperative period affects gastrointestinal function and mental well-being

Heat application group

Abdominal massage administered in the early postoperative period has an effect on gastrointestinal function and mental well-being.

Massage group

control group

placebo group

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years and older,
  • conscious and cooperative, with vital signs within normal limits after surgery,
  • who have not defecated after surgery,
  • who are able to eat orally, and
  • who have a hip fracture will be included in the study.

You may not qualify if:

  • Patients with a history of cancer, abdominal injury, delirium, or requiring intensive care will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 9, 2025

First Posted

October 6, 2025

Study Start

February 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations