NCT06379503

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

April 3, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

YogaHeart SurgeryNursing

Outcome Measures

Primary Outcomes (3)

  • sleep quality

    Pittsburgh Sleep Quality Index (PSQI)

    12 week

  • depression

    Beck Depression Inventory (BDI)

    12 week

  • life quality

    World Health Organization Quality of Life Scale (WHOQOL - BREF)

    12 week

Study Arms (2)

intervention

EXPERIMENTAL

Heart yoga practice for 12 weeks on 30 patients who underwent heart surgery

Other: HEART YOGA

control

ACTIVE COMPARATOR

routine nursing care

Other: routine nursing care

Interventions

Heart yoga; It includes regular, balanced, safe light physical exercises, breathing exercises that provide breathing control, and meditation practices that include relaxation techniques.

intervention

Basic nursing care after heart surgery

control

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül Üniversitesi Hastanesi

Izmir, Balçova, 35330, Turkey (Türkiye)

Location

Related Publications (28)

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    BACKGROUND
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    BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Sonay Göktaş, Prof. dr.

    Sağlık Bilimleri Universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist nurse

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 23, 2024

Study Start

December 15, 2021

Primary Completion

January 18, 2023

Study Completion

June 18, 2023

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations