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

NCT05366673 | Completed

• 1 other identifier: TYVH109
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Massage; Heart Failure

Keywords

heart failure; massage; fatigue; sleep quality

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Changes in Hospital Anxiety and depression scale score

  baseline, 4 day, 7 day

Study Arms (2)

Massage therapy

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients will maintain usual care.

Interventions

massage OTHER

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

Massage therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

Taipei Veterans General Hospital Taoyuan Branch

Taoyuan District, 330, Taiwan

Location

Related Publications (18)

• Polikandrioti M, Kalafatakis F, Koutelekos I, Kokoularis D. Fatigue in heart failure outpatients: levels, associated factors, and the impact on quality of life. Arch Med Sci Atheroscler Dis. 2019 May 28;4:e103-e112. doi: 10.5114/amsad.2019.85406. eCollection 2019.

  PMID: 31211277 BACKGROUND

• Akerstedt T, Hume K, Minors D, Waterhouse J. The subjective meaning of good sleep, an intraindividual approach using the Karolinska Sleep Diary. Percept Mot Skills. 1994 Aug;79(1 Pt 1):287-96. doi: 10.2466/pms.1994.79.1.287.

  PMID: 7991323 BACKGROUND

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  PMID: 2241964 BACKGROUND

• Backus D, Manella C, Bender A, Sweatman M. Impact of Massage Therapy on Fatigue, Pain, and Spasticity in People with Multiple Sclerosis: a Pilot Study. Int J Ther Massage Bodywork. 2016 Dec 9;9(4):4-13. doi: 10.3822/ijtmb.v9i4.327. eCollection 2016 Dec.

  PMID: 27974947 BACKGROUND

• 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.

  PMID: 23186129 BACKGROUND

• Chen LX, Ji DH, Zhang F, Li JH, Cui L, Bai CJ, Liu H, Liang Y. Richards-Campbell sleep questionnaire: psychometric properties of Chinese critically ill patients. Nurs Crit Care. 2019 Nov;24(6):362-368. doi: 10.1111/nicc.12357. Epub 2018 Jul 30.

  PMID: 30062842 BACKGROUND

• Chen LH, Li CY, Shieh SM, Yin WH, Chiou AF. Predictors of fatigue in patients with heart failure. J Clin Nurs. 2010 Jun;19(11-12):1588-96. doi: 10.1111/j.1365-2702.2010.03218.x.

  PMID: 20579199 BACKGROUND

• Conley S, Feder S, Redeker NS. The relationship between pain, fatigue, depression and functional performance in stable heart failure. Heart Lung. 2015 Mar-Apr;44(2):107-12. doi: 10.1016/j.hrtlng.2014.07.008. Epub 2015 Jan 6.

  PMID: 25576085 BACKGROUND

• Drouot X, Quentin S. Sleep Neurobiology and Critical Care Illness. Sleep Med Clin. 2016 Mar;11(1):105-13. doi: 10.1016/j.jsmc.2015.10.001.

  PMID: 26972037 BACKGROUND

• Evangelista LS, Moser DK, Westlake C, Pike N, Ter-Galstanyan A, Dracup K. Correlates of fatigue in patients with heart failure. Prog Cardiovasc Nurs. 2008 Winter;23(1):12-7. doi: 10.1111/j.1751-7117.2008.07275.x.

  PMID: 18326992 BACKGROUND

• Hayhoe B, Kim D, Aylin PP, Majeed FA, Cowie MR, Bottle A. Adherence to guidelines in management of symptoms suggestive of heart failure in primary care. Heart. 2019 May;105(9):678-685. doi: 10.1136/heartjnl-2018-313971. Epub 2018 Dec 4.

  PMID: 30514731 BACKGROUND

• Heo S, McSweeney J, Tsai PF, Ounpraseuth S. Differing Effects of Fatigue and Depression on Hospitalizations in Men and Women With Heart Failure. Am J Crit Care. 2016 Nov;25(6):526-534. doi: 10.4037/ajcc2016909.

  PMID: 27802954 BACKGROUND

• Huang HW, Zheng BL, Jiang L, Lin ZT, Zhang GB, Shen L, Xi XM. Effect of oral melatonin and wearing earplugs and eye masks on nocturnal sleep in healthy subjects in a simulated intensive care unit environment: which might be a more promising strategy for ICU sleep deprivation? Crit Care. 2015 Mar 19;19(1):124. doi: 10.1186/s13054-015-0842-8.

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• Fredriksson-Larsson U, Alsen P, Karlson BW, Brink E. Fatigue two months after myocardial infarction and its relationships with other concurrent symptoms, sleep quality and coping strategies. J Clin Nurs. 2015 Aug;24(15-16):2192-200. doi: 10.1111/jocn.12876. Epub 2015 May 19.

  PMID: 25988847 BACKGROUND

• 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.

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  PMID: 4352387 BACKGROUND

• 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.

  PMID: 27362512 BACKGROUND

• Sable A, Sivabalan T, Shetti AN. Effectiveness of Back Massage on Sleep Pattern among Patients with Congestive Cardiac Failure. Iran J Nurs Midwifery Res. 2017 Sep-Oct;22(5):359-362. doi: 10.4103/ijnmr.IJNMR_142_16.

  PMID: 29033989 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Fatigue; Sleep Initiation and Maintenance Disorders

Interventions

Massage

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ai-Fu Chiou, PhD

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Massage

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: October 31, 2021
• Primary Completion: December 17, 2022
• Study Completion: December 17, 2022
• Last Updated: February 21, 2024

Record last verified: 2022-08

Locations

TW (1)