Effect of Abdominal Massage on Constipation After Cardiac Surgery

NCT ID: NCT06596421

Last Updated: 2024-09-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-20

Study Completion Date

2024-05-06

Brief Summary

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

Background and Aim: Although the incidence of gastrointestinal complications after cardiovascular surgery is reported to be rare, it has been reported that patients experience problems with constipation within the week after discharge. The presence of abdominal distension due to constipation after cardiac surgery may lead to prolonged wound healing, paralytic ileus and gastric dilatation. This study aimed to evaluate the effect of abdominal massage on constipation after cardiac surgery.

Methods: A prospective, randomised controlled quasi-experimental study was conducted in the cardiovascular surgery clinic of a public hospital between September 2022 and July 2023. A power analysis was performed to determine the sample size. A total of 130 patients were randomly assigned to the experimental or control group using a simple randomisation method. Data were collected using a 21-item form from the first day after surgery. Burping and defecation times of the patients were evaluated and recorded.

Results: The mean age of the experimental group was 55.2±13.3 years, while the mean age of the control group was 60.4±10.6 years (p=0.015). There was no statistically significant difference between the groups in terms of sociodemographic characteristics, bowel preparation and preoperative fasting times. It was observed that bowel sounds started earlier in the experimental group (70.8% on the first postoperative day) compared to the control group (46.2% on the first postoperative day) (X2=16.629; p=0.005). The first burping time measurements in the control group (x̄=46.415 hours) were higher than those in the experimental group (x̄=31.262 hours). Postoperative defecation time was longer in the control group (x̄=99.51 hours) than in the experimental group (x̄=61.611 hours).

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.

Abdominal Massage

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

DOUBLE

Caregivers Investigators

Study Groups

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

experiment

abdominal massage

Group Type EXPERIMENTAL

abdominal massage

Intervention Type OTHER

abdominal massage

control

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

abdominal massage

abdominal massage

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* \- Being older than 18 years
* Agreeing to participate in the study
* Undergoing a cardiac surgery
* Not having a barrier for communication
* Not having a mental or cognitive disability
* Not using constipation treatment (like laxatives or enemas)
* Having no history of constipation disorders or gastrointestinal surgery.

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Bahçeşehir University

OTHER

Sponsor Role lead

Responsible Party

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

Gamze ataman YILDIZ

Chief Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Bahcesehir Universty

Istanbul, Istanbul, 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.

20220750

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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