Heart Failure Clinical Trial
Official title:
Effect of Massage Therapy on Fatigue and Sleep Quality in Patients With Heart Failure in Intensive Care Unit
Verified date | August 2022 |
Source | National Yang Ming University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 106 |
Est. completion date | December 17, 2022 |
Est. primary completion date | December 17, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Veterans General Hospital Taoyuan Branch | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
National Yang Ming University |
Taiwan,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Piper Fatigue Scale score | 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. | baseline, 4 day, 7 day | |
Primary | Changes in Verran and Snyder-Halpern sleep quality scale | 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. | baseline, 4 day, 7 day | |
Secondary | Changes in Hospital Anxiety and depression scale score | 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. | baseline, 4 day, 7 day |
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