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Completed

NCT Number: NCT05366673

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

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.

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Key information

Conditions

Massage Cardiovascular Diseases Dyssomnias Fatigue Heart Diseases Heart Failure Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Veterans General Hospital Taoyuan Branch

Taoyuan, 330, Taiwan

About this study

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)。

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Massage

Other

Perform a 10-minute back massage every day for a week

Primary outcomes

  1. Changes in Piper Fatigue Scale score

    Time frame: 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.

  2. Changes in Verran and Snyder-Halpern sleep quality scale

    Time frame: 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 outcomes

  1. Changes in Hospital Anxiety and depression scale score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 9, 2022
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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