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

Primary Purpose

Heart Failure, Symptoms and Signs, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Classical Massage
Benson Relaxation Exercise
Control
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Classical massage,heart failure,nursing,relaxation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ankara University Medical Faculty Ibni Sina Hospital Cardiology Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Classical Massage

Relaxation

Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2020
Last Updated
September 20, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04292665
Brief Title
Effects of Classical Massage and Benson Relaxation Exercise on Heart Failure Patients
Official Title
Randomized Controlled Trial of Classical Massage and Benson Relaxation Exercise for Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Symptoms and Signs, Quality of Life
Keywords
Classical massage,heart failure,nursing,relaxation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Classical Massage
Arm Type
Experimental
Arm Description
Patients will receive a total of fourteen individual applied classical massage sessions, twice daily for seven days, each session lasting 30 minutes.
Arm Title
Relaxation
Arm Type
Experimental
Arm Description
Patients will receive a total of fourteen individual counseling sessions, in a quiet room, twice daily for seven days, each session lasting 20 minutes.
Arm Title
Control
Arm Type
Other
Arm Description
Patients will continue to receive standard nursing care and no further intervention will be made during the research.
Intervention Type
Behavioral
Intervention Name(s)
Classical Massage
Intervention Description
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
Intervention Name(s)
Benson Relaxation Exercise
Intervention Description
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
Other
Intervention Name(s)
Control
Intervention Description
Patients will continue to receive standard nursing care and no further intervention will be made during the research.
Primary Outcome Measure Information:
Title
Change in symptom status
Description
Symptom status will be measured based on patient report by the Symptom Status Questionnaire-Heart Failure . Higher score means increase in symptom burden.
Time Frame
Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions
Title
Change in quality of life
Description
Quality of live will be measured by the Minnesota Living with Heart Failure Questionnaire. Higher scores on the scale mean worse quality of life.
Time Frame
Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra Gok Metın, Assos.Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Ankara University Medical Faculty Ibni Sina Hospital Cardiology Clinic
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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