Effect of Heart Yoga Applıed To Patıents Undergoıng Cardıovascular Surgery on Sleep, Depressıon And Qualıty of Lıfe

April 18, 2024 updated by: Kubra Oymaagaclio, Dokuz Eylul University

This type of study is a randomized controlled trial. The aim is to contribute to the literature by comparing the effects of heart yoga on the depression level, sleep and quality of life of patients who do and do not do heart yoga.

The main elements it aims to answer are:

  • Heart yoga applied to patients who have undergone heart surgery improves their sleep quality compared to those who have not.
  • Heart yoga applied to patients who have undergone heart surgery reduces the level of depression compared to those who have not.
  • Heart yoga applied to patients who have undergone heart surgery increases the quality of life compared to those who have not.

Patients who accept the study will practice heart yoga simultaneously with heart yoga videos via an online link every other day for 12 weeks after heart surgery.

Researchers will compare intervention and control groups to see if there are any effects on sleep quality, depression level, and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In order to collect the data of the study, Personal Information Form, Physiological Parameters, Pittsburgh Sleep Quality Index (PUKI), Beck Depression Inventory, World Health Organization Quality of Life Scale-Short Form were used to evaluate the individual characteristics of the patient and were collected from patients who underwent cardiovascular surgery. (Permission to use scale has been obtained.) The researcher received a certificate by participating in a national and international certified training program of 200 hours of basic yoga and 250 hours of yoga therapy training. The "Heart Yoga Guidance Booklet" was developed by the researcher in line with the guide prepared for the practice of heart yoga, the training received, literature reviews on the subject and clinical experiences. In line with this booklet, videos were created for patients to apply at home. It was easily accessible by providing an online link. In addition, a monitoring form was given every other day to ensure controlled follow-up of the patients.

The patients were randomized and the study started with patients who accepted the study. The suitability and clarity of the scales were checked with pre-application (n: 20).

In addition to routine nursing care, patients in the intervention group received heart yoga every other day for 70-80 minutes a day, starting from the 1st postoperative week until the end of the 12th week. The control group continued routine nursing care.

Evaluation scales were filled in by the patients before surgery, at the 1st week after surgery, at the 1st month after surgery, and finally at the 3rd month after surgery.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Balçova
      • İ̇zmi̇r, Balçova, Turkey, 35330
        • Dokuz Eylul Universitesi Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Research Inclusion Criteria

  • Those who have undergone cardiovascular surgery,
  • Those who are over 18 years old,
  • Oriented to person, place and time,
  • Extubated on the first day after surgery,
  • Pain control was achieved before the application,
  • Those who do not practice yoga or similar practices,
  • No verbal communication disability (hearing and speaking),
  • No physical mobility problems,
  • No obstacle to using technology,
  • Patients who volunteered to participate in the study were included in the study. Exclusion Criteria
  • Having low blood pressure,
  • The amount of drainage from the chest tube is excessive, which hinders cardiac yoga movements,
  • Those who have conditions such as asthma, chronic obstructive pulmonary disease (COPD),
  • Patients with diagnosed psychiatric and neurological disorders were excluded from the study.

Criteria for Exclusion from the Study

  • Unable to communicate during the research process,
  • Patients who wanted to leave the study during the research period were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
Heart yoga practice for 12 weeks on 30 patients who underwent heart surgery
Other: HEART YOGA
Heart yoga; It includes regular, balanced, safe light physical exercises, breathing exercises that provide breathing control, and meditation practices that include relaxation techniques.
Active Comparator: control
routine nursing care
Other: routine nursing care
Basic nursing care after heart surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep quality
Time Frame: 12 week
Pittsburgh Sleep Quality Index (PSQI)
12 week
depression
Time Frame: 12 week
Beck Depression Inventory (BDI)
12 week
life quality
Time Frame: 12 week
World Health Organization Quality of Life Scale (WHOQOL - BREF)
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Investigators

  • Principal Investigator: Sonay Göktaş, Prof. dr., Sağlık Bilimleri Universty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

January 18, 2023

Study Completion (Actual)

June 18, 2023

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/37-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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