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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05366673
• Other study ID #: TYVH109
• Status: Completed
• Phase: N/A
• Start date: October 31, 2021
• Est. completion date: December 17, 2022

Study information

• Verified date: August 2022
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)。

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Fatigue
• Heart Failure
• Massage

Intervention

Other:
• massage
Perform a 10-minute back massage every day for a week

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital Taoyuan Branch	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

References & Publications (18)

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Chen WL, Liu GJ, Yeh SH, Chiang MC, Fu MY, Hsieh YK. Effect of back massage intervention on anxiety, comfort, and physiologic responses in patients with congestive heart failure. J Altern Complement Med. 2013 May;19(5):464-70. doi: 10.1089/acm.2011.0873. Epub 2012 Nov 27. — View Citation

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Iyngkaran P, Liew D, Neil C, Driscoll A, Marwick TH, Hare DL. Moving From Heart Failure Guidelines to Clinical Practice: Gaps Contributing to Readmissions in Patients With Multiple Comorbidities and Older Age. Clin Med Insights Cardiol. 2018 Dec 4;12:1179546818809358. doi: 10.1177/1179546818809358. eCollection 2018. — View Citation

Jeon S, Redeker NS. Sleep Disturbance, Daytime Symptoms, and Functional Performance in Patients With Stable Heart Failure: A Mediation Analysis. Nurs Res. 2016 Jul-Aug;65(4):259-67. doi: 10.1097/NNR.0000000000000169. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

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