Effect of Massage Therapy on Fatigue and Sleep Quality in Patients With Heart Failure in Intensive Care Unit
Primary Purpose
Massage, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
massage
Sponsored by
About this trial
This is an interventional other trial for Massage focused on measuring heart failure, massage, fatigue, sleep quality
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.
Sites / Locations
- Taipei Veterans General Hospital Taoyuan Branch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Massage therapy
Control group
Arm Description
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.
Patients will maintain usual care.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05366673
First Posted
May 4, 2022
Last Updated
March 1, 2023
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT05366673
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
December 17, 2022 (Actual)
Study Completion Date
December 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)。
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massage, Heart Failure
Keywords
heart failure, massage, fatigue, sleep quality
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Massage
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Massage therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will maintain usual care.
Intervention Type
Other
Intervention Name(s)
massage
Intervention Description
Perform a 10-minute back massage every day for a week
Primary Outcome Measure Information:
Title
Changes in Piper Fatigue Scale score
Description
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.
Time Frame
baseline, 4 day, 7 day
Title
Changes in Verran and Snyder-Halpern sleep quality scale
Description
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.
Time Frame
baseline, 4 day, 7 day
Secondary Outcome Measure Information:
Title
Changes in Hospital Anxiety and depression scale score
Description
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.
Time Frame
baseline, 4 day, 7 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ai-Fu Chiou, PhD
Organizational Affiliation
National Yang Ming University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital Taoyuan Branch
City
Taoyuan
ZIP/Postal Code
330
Country
Taiwan
12. IPD Sharing Statement
Citations:
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31211277
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Effect of Massage Therapy on Fatigue and Sleep Quality in Patients With Heart Failure in Intensive Care Unit
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