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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04292665
Other study ID #
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2019
Est. completion date June 15, 2020

Study information

Verified date September 2021
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date June 15, 2020
Est. primary completion date May 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Ankara University Medical Faculty Ibni Sina Hospital Cardiology Clinic Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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