Effects of Classical Massage and Benson Relaxation Exercise on Heart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure; Symptoms and Signs; Quality of Life
• Interventions: Behavioral: Benson Relaxation Exercise; Other: Control; Behavioral: Classical Massage

• Registration Number: NCT04292665
• Lead Sponsor: Hacettepe University

Brief Summary

Patients with heart failure will be entered. Participants will be randomized to one of three study arms: Arm 1: Classical massage, Arm 2: Relaxation, Arm 3: Control Hypothesis: Classical Massage and Benson Muscle Relaxation will decrease frequency, severity, discomfort of symptoms and improve quality of life.

Detailed Description

Previous reports have revealed that classical massage and Benson relaxation exercise are promising for physiological parameters such as respiratory rate, pulse, blood pressure in heart failure patients. On the other hand, research examining effects of these approaches on physical symptom status that is including dyspnea, orthopnea, fatigue, chest pain, peripheral edema, sleep problems and dizziness and quality of life is limited. The present study investigates the effects of classical massage and Benson relaxation exercise in a single-site, 3-arm, randomized, controlled study of 96 patients with heart failure. Arm 1: Classical massage; Arm 2: Benson relaxation exercise; Arm 3: Control. The investigators hypothesize that Classical Massage and Benson relaxation exercise will decrease frequency, severity, discomfort of symptoms and improve quality of life.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-10-15
• Study First Submitted: 2020-03-01
• Study First Submitted QC: 2020-03-01
• Study First Posted: 2020-03-03
• Primary Completion: 2020-05-30
• Study Completion: 2020-06-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Being at least primary school graduates,
• Being over 18 years old
• Being diagnosed Stage III-IV with heart failure
• Not using any other complementary or integrative therapy during the study period

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Exclusion Criteria

• Having an additional disease such as advanced stage chronic obstructive pulmonary disease, asthma, cancer
• Stage I-II diagnosed with heart failure
• Having an active thrombosis
• Having a coagulation problem
• Not volunteering to participate in the research
• Patients who have been hospitalized for 5 days or less and discharged before five days after the start of the application.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxation	Benson Relaxation Exercise	Patients will receive a total of fourteen individual counseling sessions, in a quiet room, twice daily for seven days, each session lasting 20 minutes.
Control	Control	Patients will continue to receive standard nursing care and no further intervention will be made during the research.
Classical Massage	Classical Massage	Patients will receive a total of fourteen individual applied classical massage sessions, twice daily for seven days, each session lasting 30 minutes.

Primary Outcome Measures

Name	Time	Method
Change in symptom status	Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions	Symptom status will be measured based on patient report by the Symptom Status Questionnaire-Heart Failure . Higher score means increase in symptom burden.
Change in quality of life	Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions	Quality of live will be measured by the Minnesota Living with Heart Failure Questionnaire. Higher scores on the scale mean worse quality of life.

Trial Locations

Locations (1)

Ankara University Medical Faculty Ibni Sina Hospital Cardiology Clinic; 🇹🇷 Ankara, Turkey