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

NCT04292665 | Completed DMC

• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Symptoms and Signs; Quality of Life

Keywords

Classical massage,heart failure,nursing,relaxation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Classical Massage

EXPERIMENTAL

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

Relaxation

EXPERIMENTAL

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

Control

OTHER

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

Other: Control

Interventions

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.

Classical Massage

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.

Relaxation

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Ankara University Medical Faculty Ibni Sina Hospital Cardiology Clinic

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure; Signs and Symptoms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms

Study Officials

• Zehra Gok Metın, Assos.Prof.

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 3, 2020
• Study Start: October 15, 2019
• Primary Completion: May 30, 2020
• Study Completion: June 15, 2020
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)