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

NCT ID: NCT04292665

Last Updated: 2021-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2020-06-15

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.

Conditions

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Heart Failure Symptoms and Signs Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Classical Massage

Patients will receive a total of fourteen individual applied classical massage sessions, twice daily for seven days, each session lasting 30 minutes.

Group Type EXPERIMENTAL

Classical Massage

Intervention Type BEHAVIORAL

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.

Relaxation

Patients will receive a total of fourteen individual counseling sessions, in a quiet room, twice daily for seven days, each session lasting 20 minutes.

Group Type EXPERIMENTAL

Benson Relaxation Exercise

Intervention Type BEHAVIORAL

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.

Control

Patients will continue to receive standard nursing care and no further intervention will be made during the research.

Group Type OTHER

Control

Intervention Type OTHER

Patients will continue to receive standard nursing care and no further intervention will be made during the research.

Interventions

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Classical Massage

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.

Intervention Type BEHAVIORAL

Benson Relaxation Exercise

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.

Intervention Type BEHAVIORAL

Control

Patients will continue to receive standard nursing care and no further intervention will be made during the research.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Merve Gulbahar

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zehra Gok Metın, Assos.Prof.

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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Ankara University Medical Faculty Ibni Sina Hospital Cardiology Clinic

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

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