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CompletedNCT04837378Updated Nov 14, 2023

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

An interventional study of Abdominal Massage and In-bed Exercise in Patient Engagement, sponsored by Inonu University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-11-14.

Sponsored by Inonu University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Patient Engagement

Keywords

  • Abdominal Massage
  • Enteral Nutrition
  • Comfort
  • In-Bed Exercise
  • Intensive Care
03

In context

Lead sponsor

Inonu University is the lead sponsor of 375 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    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.

    Other: Abdominal Massage

  • Experimental
    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.

    Other: In-bed Exercise

  • No intervention
    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.

Interventions

  • OtherAbdominal 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.

  • OtherIn-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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: About 6 months

  2. 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.

    Time frame: About 6 months

  3. 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.

    Time frame: About 6 months

  4. 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.

    Time frame: About 6 months

07

Study locations

1 site
  • SBÜ Gazi Yaşargil Training and Research Hospital
    Diyarbakır, 21070, Turkey
08

References and documents

Individual participant data

Plan to share: No — This research is a doctoral thesis study. The research is expected to be completed.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04837378
Lead sponsor
Inonu University
Responsible party
Zeliha CENGİZ (Principal Investigator, Inonu University) — Principal investigator
First posted
Apr 8, 2021
Start date
Apr 15, 2021
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Nov 14, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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