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

September 20, 2021 updated by: Merve Gulbahar, Hacettepe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Ankara University Medical Faculty Ibni Sina Hospital Cardiology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Classical Massage
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
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.
EXPERIMENTAL: 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.
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.
OTHER: Control
Patients will continue to receive standard nursing care and no further intervention will be made during the research.
Other: Control
Patients will continue to receive standard nursing care and no further intervention will be made during the research.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in symptom status
Time Frame: 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.
Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions
Change in quality of life
Time Frame: 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.
Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Director: Zehra Gok Metın, Assos.Prof., Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2019

Primary Completion (ACTUAL)

May 30, 2020

Study Completion (ACTUAL)

June 15, 2020

Study Registration Dates

First Submitted

March 1, 2020

First Submitted That Met QC Criteria

March 1, 2020

First Posted (ACTUAL)

March 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Classical Massage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe