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NCT Number: NCT04292665

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Symptoms and Signs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Medical Faculty Ibni Sina Hospital Cardiology Clinic

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Classical massage

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.

benson relaxation exercise

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

Other

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2020
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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