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

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT04292665
Collaborator
(none)
72
1
3
8
9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Classical Massage
  • Behavioral: Benson Relaxation Exercise
  • Other: Control
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Randomized Controlled Trial of Classical Massage and Benson Relaxation Exercise for Patients With Heart Failure
Actual Study Start Date :
Oct 15, 2019
Actual Primary Completion Date :
May 30, 2020
Actual Study Completion Date :
Jun 15, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara University Medical Faculty Ibni Sina Hospital Cardiology Clinic Ankara Turkey 06100

Sponsors and Collaborators

  • Hacettepe University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merve Gulbahar, Research Assistant, Hacettepe University
ClinicalTrials.gov Identifier:
NCT04292665
Other Study ID Numbers:
    First Posted:
    Mar 3, 2020
    Last Update Posted:
    Sep 27, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Merve Gulbahar, Research Assistant, Hacettepe University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 27, 2021