Clinical trial NCT05366673: Effect of Massage Therapy on Fatigue and Sleep Quality in Patients With Heart Failure in Intensive Care Unit
Official title: Effect of Massage Therapy on Fatigue and Sleep Quality in Patients With Heart Failure in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Massage
Heart Failure
Keywords: heart failure
massage
fatigue
sleep quality
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Massage
Primary purpose: OTHER

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)。

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Piper Fatigue Scale score
timeFrame: baseline, 4 day, 7 day
measure: Changes in Verran and Snyder-Halpern sleep quality scale
timeFrame: baseline, 4 day, 7 day
Secondary outcomes:
measure: Changes in Hospital Anxiety and depression scale score
timeFrame: baseline, 4 day, 7 day
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Taipei Veterans General Hospital Taoyuan Branch
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Ai-Fu Chiou, PhD
role: PRINCIPAL_INVESTIGATOR
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