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

NCT04837378 | Completed DMC

• 1 other identifier: 2021/1839
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Engagement

Keywords

Abdominal Massage; Enteral Nutrition; Comfort; In-Bed Exercise; Intensive Care

Outcome Measures

Primary Outcomes (4)

• The effect of abdominal massage on gastrointestinal complications

  Abdominal massage was repeated for 3 days, and gastric residual volume, defecation frequency, vomiting number, abdominal distension, constipation and diarrhea status and blood glucose measurement were recorded before each abdominal massage.

  About 6 months

• The effect of abdominal massage on patient comfort

  Comfort behavior checklist (CBC) consists of 30 behavioral indicators, pain and comfort scores. Minimum score is 25, maximum score is 100. High scores indicate a high level of comfort. Scoring was done before and after abdominal massage.

  About 6 months

• Effects of in-bed exercise on gastrointestinal complications

  The in-bed exercise was repeated for 3 days and the gastric residual volume, defecation frequency, vomiting number, abdominal distension, constipation and diarrhea status, and blood glucose measurement were recorded in the enteral nutrition follow-up form before each exercise.

  About 6 months

• The effect of in-bed exercise on patient comfort

  The comfort behavior checklist (CBC) consists of 30 behavioral indicators, pain and comfort scores. Minimum score is 25, maximum score is 100. High scores indicate a high level of comfort. Scoring was done before and after the in-bed exercise.

  About 6 months

Study Arms (3)

Abdominal Massage Group

EXPERIMENTAL

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.

Other: Abdominal Massage

In-bed Exercise Group

EXPERIMENTAL

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.

Other: In-bed Exercise

Control Group

NO INTERVENTION

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

Interventions

Abdominal Massage 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.

Abdominal Massage Group

In-bed Exercise 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.

In-bed Exercise Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

SBÜ Gazi Yaşargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 8, 2021
• Study Start: April 15, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)