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,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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
Klip A, Ramlal T, Bilan PJ, Cartee GD, Gulve EA, Holloszy JO. Recruitment of GLUT-4 glucose transporters by insulin in diabetic rat skeletal muscle. Biochem Biophys Res Commun. 1990 Oct 30;172(2):728-36. doi: 10.1016/0006-291x(90)90735-6. — View Citation
Nahmias AJ, Naib ZM, Josey WE, Franklin E, Jenkins R. Prospective studies of the association of genital herpes simplex infection and cervical anaplasia. Cancer Res. 1973 Jun;33(6):1491-7. No abstract available. — View Citation
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. — View Citation
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. — View Citation
* 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|