The Effect of Abdominal Massage and In-bed Exercise on Enteral Nutrition

NCT ID: NCT04837378

Last Updated: 2023-11-14

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

2021-04-15

Study Completion Date

2022-08-31

Brief Summary

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

Enteral nutrition is often preferred in intensive care units, but it brings some potential complications in addition to its benefits. It is stated that abdominal massage and in-bed exercise in intensive care patients can reduce complications related to the gastrointestinal system when performed under appropriate conditions. Considering the ease of application, low cost and non-invasive nature of abdominal massage and in-bed exercises, it is predicted that patients will benefit in case of gastrointestinal complications and positive effects on comfort. It is also thought that these interventions that support independent nursing roles will contribute to the establishment of standards of care and the professionalization process by using evidence-based practices.

This study is conducted to evaluate the effects of abdominal massage and in-bed exercise on gastrointestinal complications and patient comfort in intensive care patients who are fed enterally.

Detailed Description

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

Enteral nutrition is often preferred in intensive care units, but it brings some potential complications in addition to its benefits. It is stated that abdominal massage and in-bed exercise in intensive care patients can reduce complications related to the gastrointestinal system when performed under appropriate conditions. Considering the ease of application, low cost and non-invasive nature of abdominal massage and in-bed exercises, it is predicted that patients will benefit in case of gastrointestinal complications and positive effects on comfort. It is also thought that these interventions that support independent nursing roles will contribute to the establishment of standards of care and the professionalization process by using evidence-based practices.

This study is conducted to evaluate the effects of abdominal massage and in-bed exercise on gastrointestinal complications and patient comfort in intensive care patients who are fed enterally.

The research is planned to be completed between April 15, 2021 and July 15, 2022. The universe of the study, which was conducted as a randomized controlled study model, consisted of patients with intubated enteral nutrition in the internal intensive care units of Diyarbakır Gazi Yaşargil Training and Research Hospital and Dicle University Medical Faculty. Participants were planned to be assigned to the experimental and control groups by stratification and block randomization (Abdominal massage group = 46 participant, in-bed exercise group = 46 participant and control group = 46 participant). Demographic Characteristics Form, Enteral Nutrition Follow-up Form, Richmond Agitation-Sedation Scale, Intensive Care Pain Observation Scale and Comfort Behavior Checklist were used to collect data. According to the characteristics of the data, t test, ANOVA test, Mann Whitney U test and correlation were measured in independent groups.

Conditions

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

Patient Engagement

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

In the study, patients will be stratified according to their gender (male and female) status and the blocking process will be performed. 46 patients will be included in each group by repeating the layers formed according to the specified variables 3 times. The stratified patients will be assigned to the experimental and control groups, and the research groups will be written on papers for the determined sets and a lot will be drawn.

Group 1: Abdominal Massage 2. Group: In-bed Exercise 3. Group: Control
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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

Abdominal Massage Group

Abdominal massage process stage; After the preliminary test data were obtained, the hands were warmed and creamed with vaseline, abdominal massage was applied to the patient in the supine position for 15 minutes. After 24 hours, gastrointestinal complications and comfort parameters were recorded.

Group Type EXPERIMENTAL

Abdominal Massage

Intervention Type OTHER

The massage starts from the left lower quadrant of the sigmoid colon. After the initial tension is removed, deep effloration, petrization and vibration maneuvers are started. Finally, the process is completed in about 15 minutes to cover the entire column.

In-bed Exercise Group

In-bed exercise process phase; After the pre-test data were obtained, the patient was applied passive in-bed exercises for approximately 15 minutes in all extremities in the supine position. After 24 hours, gastrointestinal complications and comfort parameters were recorded.

Group Type EXPERIMENTAL

In-bed Exercise

Intervention Type OTHER

In-bed exercises are passive exercises performed by caregivers when the patient is dependent on the bed, that is, when he cannot actively move on his own. These are movements applied to all joints of the upper and lower extremities and in all directions. Exercises are done in all directions on finger joints of both hands, wrists, elbow and shoulder joints, finger joints of both feet, ankles, knee and hip joints.

Control Group

Control group stage; Gastrointestinal complications and comfort parameters were recorded in this group at the same time as the experimental groups without any 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

The massage starts from the left lower quadrant of the sigmoid colon. After the initial tension is removed, deep effloration, petrization and vibration maneuvers are started. Finally, the process is completed in about 15 minutes to cover the entire column.

Intervention Type OTHER

In-bed Exercise

In-bed exercises are passive exercises performed by caregivers when the patient is dependent on the bed, that is, when he cannot actively move on his own. These are movements applied to all joints of the upper and lower extremities and in all directions. Exercises are done in all directions on finger joints of both hands, wrists, elbow and shoulder joints, finger joints of both feet, ankles, knee and hip joints.

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 connected to a mechanical ventilator

* Patients who started enteral feeding with a nasogastric tube at least 24 hours ago
* Patients with no injuries to the extremity and abdominal area
* Patients without intestinal obstruction
* Patients who have not received abdominal radiotherapy and have not undergone abdominal surgery during the last six weeks
* Patients with Glasgow Coma Score (GCS) \> 3
* Patients with Acute Physiology and Chronic Health Evaluation (APACHE II)\> 16
* Patients given consent by their first-degree relative

Exclusion Criteria

* • Patients whose enteral feeding was discontinued during the study

* Patients who show signs of infection due to VAP or other infections during or before the study
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.

Inonu University

OTHER

Sponsor Role lead

Responsible Party

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

Zeliha CENGİZ

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

SBÜ Gazi Yaşargil Training and Research Hospital

Diyarbakır, , 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.

2021/1839

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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