The Effect of Heat Application and Abdominal Massage on the Gastrointestinal System and Mental Well-being of Patients With Hip Fractures

NCT ID: NCT07208955

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Function Mental Well-being

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Heat application group

The experimental group will receive heat application

Group Type EXPERIMENTAL

heat application

Intervention Type PROCEDURE

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

Massage group

The massage group will receive abdominal massage.

Group Type EXPERIMENTAL

abdominal massage

Intervention Type PROCEDURE

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

placebo group

No intervention will be performed on the placebo group.

Group Type PLACEBO_COMPARATOR

control group

Intervention Type OTHER

control group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

heat application

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

Intervention Type PROCEDURE

abdominal massage

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

Intervention Type PROCEDURE

control group

control group

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

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

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cukurova University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Acelya Turkmen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cukurova University

Adana, Adana, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

151

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.