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

Sponsor

National Yang Ming University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05366673

Collaborator

(none)

Enrollment

Location

Arms

12.5

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

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 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.

Condition or Disease	Intervention/Treatment	Phase
Massage Heart Failure	Other: massage	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

MassageMassage

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 15, 2021

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Massage therapy 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.	Other: massage Perform a 10-minute back massage every day for a week
No Intervention: Control group Patients will maintain usual care.

Arm

Intervention/Treatment

Experimental: Massage therapy

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.

Other: massage

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

No Intervention: Control group

Patients will maintain usual care.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.