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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Classical Massage and Benson Relaxation Exercise for Patients With Heart Failure

Conditions
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Heart Failure, Symptoms and Signs, Quality of Life

Intervention / Treatment
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* Behavioral: Classical Massage
* Behavioral: Benson Relaxation Exercise
* Other: Control


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Classical Massage<br>Patients will receive a total of fourteen individual applied classical massage sessions, twice daily for seven days, each session lasting 30 minutes. | Behavioral: Classical Massage<br>* During the first interview, a booklet explaining the introduction, purpose, benefits and application steps of hand-foot massage will be given to the patients in the classical massage group. Hand and foot massage will be applied to the patients for 30 minutes in the form of right hand five minutes, left hand five minutes, right foot ten minutes, left foot ten minutes, using liquid vaseline in each session twice a day in the patient's own bed with individual applied sessions by the researcher. Patients will receive a total of 14 sessions of classical massage, twice a day, for seven days.<br>|
| Experimental: Relaxation<br>Patients will receive a total of fourteen individual counseling sessions, in a quiet room, twice daily for seven days, each session lasting 20 minutes. | Behavioral: Benson Relaxation Exercise<br>* During the first interview, patients will be given a booklet explaining the description, purpose, benefits and application steps of the Benson relaxation exercise. With individual counseling sessions, a total of 14 sessions of Benson relaxation exercises will be performed in a quiet room, twice a day for seven days, each session lasting 20 minutes. At the beginning of the application, patients will focus on their breaths by taking slow and natural breaths with the researchers' commands and will quietly say to yourself the words of the focus, sound, sentence or prayer they choose, which are meaningful to them.<br>|
| Other: Control<br>Patients will continue to receive standard nursing care and no further intervention will be made during the research. | Other: Control<br>* Patients will continue to receive standard nursing care and no further intervention will be made during the research.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Classical massage,heart failure,nursing,relaxation