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Cardiac DiseaseNCT06379503

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

A study testing HEART YOGA and routine nursing care in people with Cardiac Disease and Yoga, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 70 years
Conditions the study is for
Cardiac Disease, Yoga, Nursing Caries
What is being tested?
HEART YOGA and routine nursing care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2021to 18 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Dokuz Eylül Üniversitesi Hastanesi

    Izmir, Balçova, 35330

Other trials in Turkey (Türkiye)

About this study

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:

Read more
  • 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.

Read the 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.

Being tested
HEART YOGA, routine nursing care
Keywords
Yoga, Heart Surgery, Nursing
Medical subject headings
Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HEART YOGAOther

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

  • routine nursing careOther

    Basic nursing care after heart surgery

Study groups in NCT06379503
Study groupRoleWhat they receive
interventionExperimentalHeart yoga practice for 12 weeks on 30 patients who underwent heart surgery
Receives: Other: HEART YOGA
controlActive comparatorroutine nursing care
Receives: Other: routine nursing care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sleep quality

    Pittsburgh Sleep Quality Index (PSQI)

    Measured: 12 week

  2. depression

    Beck Depression Inventory (BDI)

    Measured: 12 week

  3. life quality

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

    Measured: 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2024
  2. Study start15 Dec 2021
  3. Primary completion18 Jan 2023
  4. Study completion18 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
Model description
randomized controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06379503
Sponsor's protocol ID
2021/37-04
Status last verified
Apr 2024
First submitted
3 Apr 2024
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Emoto T, Yamashita T, Sasaki N, Hirota Y, Hayashi T, So A, Kasahara K, Yodoi K, Matsumoto T, Mizoguchi T, Ogawa W, Hirata K. Analysis of Gut Microbiota in Coronary Artery Disease Patients: a Possible Link between Gut Microbiota and Coronary Artery Disease. J Atheroscler Thromb. 2016 Aug 1;23(8):908-21. doi: 10.5551/jat.32672. Epub 2016 Mar 5.

    PubMed 26947598

  • Ball L, Costantino F, Pelosi P. Postoperative complications of patients undergoing cardiac surgery. Curr Opin Crit Care. 2016 Aug;22(4):386-92. doi: 10.1097/MCC.0000000000000319.

    PubMed 27309972

  • Chrastina J, Novak Z, Brichta J, Pavlik P, Riha I, Nemec P. Neurosurgical treatment of cerebrovascular complications of heart surgeries and interventions. Turk Neurosurg. 2014;24(6):897-905. doi: 10.5137/1019-5149.JTN.10240-13.0.

    PubMed 25448207

  • Smeltzer, S. C., Bare, B.G., Hinkle, J. L., Cheever, K. H. (2010). Postoperative Nursing Management. In: Brunner & Suddarth's Textbook of Medical-Surgical Nursing, 12th.ed. China: Wolters Kluwers Health/Lippincott Williams&Wilkins; 461-478.

  • Shafiq A, Jayaram N, Gosch KL, Spertus JA, Buchanan DM, Decker C, Kosiborod M, Arnold SV. The Association Between Complementary and Alternative Medicine and Health Status Following Acute Myocardial Infarction. Clin Cardiol. 2016 Aug;39(8):440-5. doi: 10.1002/clc.22559. Epub 2016 May 31.

    PubMed 27244586

  • Erdoğan Z, Oğuz S, Erol E. (2012). Use of complementary therapies in the patients with heart disease. Spatula DD; 2(3):135-9.

  • Haefner J. Complementary and Integrative Health Practices for Depression. J Psychosoc Nurs Ment Health Serv. 2017 Dec 1;55(12):22-33. doi: 10.3928/02793695-20170905-02. Epub 2017 Sep 12.

    PubMed 28892554

  • Şahin N, Aydın D, Akay B. (2019). The attitudes of nursing students towards holistic complementary and alternative medicine. Balıkesir Health Sciences Journal;8(1):21-6.

  • Cramer H, Lauche R, Haller H, Steckhan N, Michalsen A, Dobos G. Effects of yoga on cardiovascular disease risk factors: a systematic review and meta-analysis. Int J Cardiol. 2014 May 1;173(2):170-83. doi: 10.1016/j.ijcard.2014.02.017. Epub 2014 Feb 25.

    PubMed 24636547

  • Birdee GS, Ayala SG, Wallston KA. Cross-sectional analysis of health-related quality of life and elements of yoga practice. BMC Complement Altern Med. 2017 Jan 31;17(1):83. doi: 10.1186/s12906-017-1599-1.

    PubMed 28143469

  • Gordon L, McGrowder DA, Pena YT, Cabrera E, Lawrence-Wright M. Effect of exercise therapy on lipid parameters in patients with end-stage renal disease on hemodialysis. J Lab Physicians. 2012 Jan;4(1):17-23. doi: 10.4103/0974-2727.98665.

    PubMed 22923917

  • KauricKlein Z. Effect of yoga on physical and psychological outcomes in patients on chronic hemodialysis. Complement Ther Clin Pract. 2019 Feb;34:41-45. doi: 10.1016/j.ctcp.2018.11.004. Epub 2018 Nov 7.

    PubMed 30712744

  • Manaf, A. (2012). Yoga Asana The Art of Body Exercise (3. Baskı). İstanbul: Şan Ofset Baskı.

  • Ünlü, B. (2007). Yoga For Everyone (B. Özükan, Ed.). İstanbul: Boyut Publishing.

  • Krishna BH, Pal P, G K P, J B, E J, Y S, M G S, G S G. Effect of yoga therapy on heart rate, blood pressure and cardiac autonomic function in heart failure. J Clin Diagn Res. 2014 Jan;8(1):14-6. doi: 10.7860/JCDR/2014/7844.3983. Epub 2014 Jan 12.

    PubMed 24596712

Questions about this trial

What is this clinical trial studying?

A study testing HEART YOGA and routine nursing care in people with Cardiac Disease and Yoga, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sleep quality (time frame: 12 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06379503, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.

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