Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-26 @ 5:01 AM
Study NCT ID:
NCT06379503
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2024-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Heart Yoga Applıed To Patıents Undergoıng Cardıovascular Surgery on Sleep, Depressıon And Qualıty of Lıfe
Sponsor:
Organization:
Raw JSON
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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.'}, {'pmid': '27309972', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25448207', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '27244586', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Erdoğan Z, Oğuz S, Erol E. (2012). Use of complementary therapies in the patients with heart disease. Spatula DD; 2(3):135-9.'}, {'pmid': '28892554', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24636547', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28143469', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22923917', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30712744', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Manaf, A. (2012). Yoga Asana The Art of Body Exercise (3. Baskı). İstanbul: Şan Ofset Baskı.'}, {'type': 'BACKGROUND', 'citation': 'Ünlü, B. (2007). Yoga For Everyone (B. Özükan, Ed.). İstanbul: Boyut Publishing.'}, {'pmid': '24596712', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24825181', 'type': 'BACKGROUND', 'citation': 'Hartley L, Dyakova M, Holmes J, Clarke A, Lee MS, Ernst E, Rees K. Yoga for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2014 May 13;2014(5):CD010072. doi: 10.1002/14651858.CD010072.pub2.'}, {'pmid': '25443600', 'type': 'BACKGROUND', 'citation': 'Manchanda SC. Yoga--a promising technique to control cardiovascular disease. Indian Heart J. 2014 Sep-Oct;66(5):487-9. doi: 10.1016/j.ihj.2014.08.013. Epub 2014 Oct 8. No abstract available.'}, {'pmid': '27261984', 'type': 'BACKGROUND', 'citation': 'Jones SM, Guthrie KA, Reed SD, Landis CA, Sternfeld B, LaCroix AZ, Dunn A, Burr RL, Newton KM. A yoga & exercise randomized controlled trial for vasomotor symptoms: Effects on heart rate variability. Complement Ther Med. 2016 Jun;26:66-71. doi: 10.1016/j.ctim.2016.03.001. Epub 2016 Mar 4.'}, {'pmid': '26976659', 'type': 'BACKGROUND', 'citation': 'Wahlstrom M, Rydell Karlsson M, Medin J, Frykman V. Effects of yoga in patients with paroxysmal atrial fibrillation - a randomized controlled study. Eur J Cardiovasc Nurs. 2017 Jan;16(1):57-63. doi: 10.1177/1474515116637734. Epub 2016 Jul 7.'}, {'pmid': '26689218', 'type': 'BACKGROUND', 'citation': 'Barrows JL, Fleury J. Systematic Review of Yoga Interventions to Promote Cardiovascular Health in Older Adults. West J Nurs Res. 2016 Jun;38(6):753-81. doi: 10.1177/0193945915618610. Epub 2015 Dec 21.'}, {'pmid': '20797598', 'type': 'BACKGROUND', 'citation': 'Howie-Esquivel J, Lee J, Collier G, Mehling W, Fleischmann K. Yoga in heart failure patients: a pilot study. J Card Fail. 2010 Sep;16(9):742-9. doi: 10.1016/j.cardfail.2010.04.011. Epub 2010 Jun 8.'}, {'pmid': '24771460', 'type': 'BACKGROUND', 'citation': 'Taylor RS, Sagar VA, Davies EJ, Briscoe S, Coats AJ, Dalal H, Lough F, Rees K, Singh S. Exercise-based rehabilitation for heart failure. Cochrane Database Syst Rev. 2014 Apr 27;2014(4):CD003331. doi: 10.1002/14651858.CD003331.pub4.'}, {'pmid': '28115415', 'type': 'BACKGROUND', 'citation': 'Kuehn BM. Emerging Data Support Benefits of Yoga for Patients With Heart Disease. Circulation. 2017 Jan 24;135(4):398-399. doi: 10.1161/CIRCULATIONAHA.116.026989. No abstract available.'}, {'pmid': '28128646', 'type': 'BACKGROUND', 'citation': 'Hagglund E, Hagerman I, Dencker K, Stromberg A. Effects of yoga versus hydrotherapy training on health-related quality of life and exercise capacity in patients with heart failure: A randomized controlled study. Eur J Cardiovasc Nurs. 2017 Jun;16(5):381-389. doi: 10.1177/1474515117690297. Epub 2017 Jan 27.'}, {'pmid': '26130018', 'type': 'BACKGROUND', 'citation': 'Kwong JS, Lau HL, Yeung F, Chau PH. Yoga for secondary prevention of coronary heart disease. Cochrane Database Syst Rev. 2015 Jul 1;2015(7):CD009506. doi: 10.1002/14651858.CD009506.pub4.'}, {'pmid': '19952833', 'type': 'BACKGROUND', 'citation': 'Pullen PR, Thompson WR, Benardot D, Brandon LJ, Mehta PK, Rifai L, Vadnais DS, Parrott JM, Khan BV. Benefits of yoga for African American heart failure patients. Med Sci Sports Exerc. 2010 Apr;42(4):651-7. doi: 10.1249/MSS.0b013e3181bf24c4.'}, {'pmid': '31021995', 'type': 'BACKGROUND', 'citation': 'Guddeti RR, Dang G, Williams MA, Alla VM. Role of Yoga in Cardiac Disease and Rehabilitation. J Cardiopulm Rehabil Prev. 2019 May;39(3):146-152. doi: 10.1097/HCR.0000000000000372.'}, {'type': 'BACKGROUND', 'citation': 'Akyol, A., Yesilbalkan, O. U., Kutlay, E., Kankaya, H., Menekli, T., & Fadiloglu, C. (2018). The Effects of Exercise on Quality of Life and Physiological Parameters in Obese Nursing Students/Obez Hemsirelik Ogrencilerinde Egzersizin Yasam Kalitesi ve Fizyolojik Parametrelere Olan Etkisi. Journal of Education and Research in Nursing, 15(3), 161-170.'}], 'seeAlsoLinks': [{'url': 'https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)?gad_source=1&gclid=EAIaIQobChMIo5Xp6t6lhQMVMZFoCR0iUg3rEAAYASAAEgKTp_D_BwE', 'label': 'World Health Organization (2021). Cardiovascular Diseases. Accessed on 26.07.2021 from https://www.who.int/health-topics/cardiovascular-diseases#tab=tab\\_1.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main elements it aims to answer are:\n\n* Heart yoga applied to patients who have undergone heart surgery improves their sleep quality compared to those who have not.\n* Heart yoga applied to patients who have undergone heart surgery reduces the level of depression compared to those who have not.\n* Heart yoga applied to patients who have undergone heart surgery increases the quality of life compared to those who have not.\n\nPatients 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.\n\nResearchers will compare intervention and control groups to see if there are any effects on sleep quality, depression level, and quality of life.', 'detailedDescription': '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.\n\nThe 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).\n\nIn 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.\n\nEvaluation 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Research Inclusion Criteria\n\n* Those who have undergone cardiovascular surgery,\n* Those who are over 18 years old,\n* Oriented to person, place and time,\n* Extubated on the first day after surgery,\n* Pain control was achieved before the application,\n* Those who do not practice yoga or similar practices,\n* No verbal communication disability (hearing and speaking),\n* No physical mobility problems,\n* No obstacle to using technology,\n* Patients who volunteered to participate in the study were included in the study. Exclusion Criteria\n* Having low blood pressure,\n* The amount of drainage from the chest tube is excessive, which hinders cardiac yoga movements,\n* Those who have conditions such as asthma, chronic obstructive pulmonary disease (COPD),\n* Patients with diagnosed psychiatric and neurological disorders were excluded from the study.\n\nCriteria for Exclusion from the Study\n\n* Unable to communicate during the research process,\n* Patients who wanted to leave the study during the research period were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06379503', 'briefTitle': 'Effect of Heart Yoga Applıed To Patıents Undergoıng Cardıovascular Surgery on Sleep, Depressıon And Qualıty of Lıfe', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Effect of Heart Yoga Applıed To Patıents Undergoıng Cardıovascular Surgery on Sleep, Depressıon And Qualıty of Lıfe', 'orgStudyIdInfo': {'id': '2021/37-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'Heart yoga practice for 12 weeks on 30 patients who underwent heart surgery', 'interventionNames': ['Other: HEART YOGA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'routine nursing care', 'interventionNames': ['Other: routine nursing care']}], 'interventions': [{'name': 'HEART YOGA', 'type': 'OTHER', 'description': 'Heart yoga; It includes regular, balanced, safe light physical exercises, breathing exercises that provide breathing control, and meditation practices that include relaxation techniques.', 'armGroupLabels': ['intervention']}, {'name': 'routine nursing care', 'type': 'OTHER', 'description': 'Basic nursing care after heart surgery', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35330', 'city': 'Izmir', 'state': 'Balçova', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylül Üniversitesi Hastanesi', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Sonay Göktaş, Prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sağlık Bilimleri Universty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'specialist nurse', 'investigatorFullName': 'Kubra Oymaagaclio', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}