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

Patient Engagement Clinical Trial

Official title:

Effects of Abdominal Massage and In-Bed Exercise on Gastrointestinal Complications and Patient Comfort in Intensive Care Patients Eating Enterally

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04837378
• Other study ID #: 2021/1839
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2023
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Patient Engagement

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	SBÜ Gazi Yasargil Training and Research Hospital	Diyarbakir

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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