Effect of Massage Therapy on Fatigue and Sleep Quality in Patients With Heart Failure in Intensive Care Unit

Not Applicable

Completed

• Conditions: Massage; Heart Failure
• Interventions: Other: massage

• Registration Number: NCT05366673
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief Summary

The purpose of this study was to explore the effect of massage therapy on fatigue and sleep quality in patients with heart failure in the intensive care unit. The study design was a randomized control trial and repeated measurements. A convenience sampling was used to recruit heart failure patients with New York Heart Association (NYHA) II-III from the intensive care unit of a regional teaching center. In addition to routine turning, patients in the experimental group received daily back massage intervention for 10 minute, once a day; the control group maintained usual care. The data collection included three time points: baseline, 4th and 7th day after the intervention. Research tools include basic personal data, Piper fatigue scale and Pittsburgh sleep quality scale.

Detailed Description

The purpose of this study was to explore the effect of massage therapy on fatigue and sleep quality in patients with heart failure in the intensive care unit. The study design was a randomized control trial and repeated measurements. A convenience sampling was used to recruit heart failure patients with New York Heart Association (NYHA) II-III from the intensive care unit of a regional teaching center. In addition to routine turning, patients in the experimental group received daily back massage intervention for 10 minute, once a day; the control group maintained usual care. The data collection included three time points: baseline, 4th and 7th day after the intervention. Research tools include basic personal data, Piper fatigue scale and Pittsburgh sleep quality scale. Data will be analyzed by descriptive statistics, chi-square test, Pearson product correlation, one-way ANOVA, independent sample t test, repeated measure ANOVA, and generalized estimating equation (GEE)。

Study Timeline

• Study Start: 2021-10-31
• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Status Verified: 2022-08
• Primary Completion: 2022-12-17
• Study Completion: 2022-12-17
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Patients with heart failure diagnosed by a physician and grade II to III according to NYHA classification, and those who can perform massage therapy after the physician's evaluation
• Over 20 years old
• A person who has a clear consciousness and can communicate
• Those who are willing to accept the implementation of this research plan

Exclusion Criteria

• People with sleep disorders
• People with mental or cognitive impairment
• Patients who use sedatives or neuroleptics
• Patients with unstable angina, myocardial infarction, and unstable vital signs
• Those who are unconscious and unable to communicate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Massage therapy	massage	Patients will receive massage therapy for 10 minutes, once per day from the first day to the seventh day of admission to the intensive care unit.

Primary Outcome Measures

Name	Time	Method
Changes in Piper Fatigue Scale score	baseline, 4 day, 7 day	Changes from baseline Piper Fatigue Scale score at 4 days, 7 days. Piper Fatigue Scale contains 15 items. Each item score ranges 0 to 3 with a total score ranged from 0 to 45, higher scores indicate higher fatigue levels.
Changes in Verran and Snyder-Halpern sleep quality scale	baseline, 4 day, 7 day	Changes from baseline Verran and Snyder-Halpern sleep quality Scale score at 4 days, 7 days. Verran and Snyder-Halpern sleep scale includes 15 items. Each item score ranges from 0-100. Higher score indicates poor sleep.

Secondary Outcome Measures

Name	Time	Method
Changes in Hospital Anxiety and depression scale score	baseline, 4 day, 7 day	Changes from baseline Hospital Anxiety and depression Scale score at 4 days, 7 days. Hospital Anxiety and Depression Scale includes 14 items, 2 subscales. Each item score ranges from 0 to 3 with a total score of 0-21 for anxiety and depression subscale. Higher score indicates high anxiety and depression.

Trial Locations

Locations (1)

Taipei Veterans General Hospital Taoyuan Branch; 🇨🇳 Taoyuan, Taiwan