Clinical trial NCT04837378: The Effect of Abdominal Massage and In-bed Exercise on Enteral Nutrition
Official title: Effects of Abdominal Massage and In-Bed Exercise on Gastrointestinal Complications and Patient Comfort in Intensive Care Patients Eating Enterally
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Engagement
Keywords: Abdominal Massage
Enteral Nutrition
Comfort
In-Bed Exercise
Intensive Care
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The effect of abdominal massage on gastrointestinal complications
timeFrame: About 6 months
measure: The effect of abdominal massage on patient comfort
timeFrame: About 6 months
measure: Effects of in-bed exercise on gastrointestinal complications
timeFrame: About 6 months
measure: The effect of in-bed exercise on patient comfort
timeFrame: About 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: SBÜ Gazi Yaşargil Training and Research Hospital
Study officials:
References: