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IRCT20251229068488N1 IRCT 2026-02-02 Tehran University of Medical Sciences Investigating the effect of yoga breathing on quality of sleep and life in heart failure patients Investigating the effect of yoga breathing on quality of sleep and life in heart failure patients 2026-02-17 anticipated 88 Complete https://irct.ir/trial/88661 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sample members will be divided into two groups: control and intervention using a block random allocation method with blocks of 4. For this purpose, blocks of 4 will be selected, so that the intervention group will be assigned the letter A and the control group will be assigned the letter B. Each block should include 2 people in the intervention group (A) and 2 people in the control group (B). The 22 possible allocation scenarios will be written on separate cards and each card will be assigned a number from 1 to 22, as follows: BBAA(1 AABB(2 BAAB(3 ABBA(4 BABA(5 AABB(6 ABBA(7 BBAA(8 ABAB(9 BAAB(10 ABAB(11. N/A heart failure. Intervention 1: Intervention group: Intervention group: The intervention included training and implementation of yoga breathing techniques (pranayama), in the form of daily 30-minute online sessions, on Google Meet and WhatsApp, for 7 weeks. The exercises used have been previously approved and content reviewed by yoga and Iranian medicine specialist Dr. Azadeh Zarei. The student researcher provides the training live and the patients practice simultaneously. If the movements are performed incorrectly, necessary corrections are made. Patient adherence is monitored through attendance at sessions and correct execution of the exercises. The intervention group is also given an educational booklet that includes an introduction to heart failure and yoga, scientific and safety basics, instructions for preparing the person and the environment, a description of breathing exercises, a weekly program with a monitoring chart, frequently asked questions, a final note, and a blank page for recording patient notes or symptoms. One week after the end of the intervention (7 weeks), in the eighth week, the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) and the Pittsburgh Sleep Quality Questionnaire (PSQI) will be completed again by the participants, and the results will be compared with pre-intervention data. The yoga exercises used in this study include the following: Naadi Shodhan Pranayam; Om Chanting; Ujjayi Pranayam; Bhramari Pranayam; Sheetali/Sheetkari; Yog Nidra in Shavasan. Intervention 2: Control group: Patients in the control group were advised usual heart failure care and standard treatment based on the 2017 AHA/ACC guidelines, including pharmacological interventions and lifestyle changes. Control group participants were encouraged to walk briskly for at least 40 minutes daily; limit alcohol and sodium intake; follow the DASH diet; avoid smoking; and continue their medication. Yes - There is a plan to make this available What will be shared: The de-identified data for this study includes general demographic information and results from research instruments (such as questionnaires, checklists, or clinical measurements). These data are stored in SPSS or Excel software files. Access to data after publication of the original results will be possible only for non-commercial research purposes and upon submitting a written request along with a brief research plan to the principal investigator. Any use requires acknowledgement of the original source. All shareable data is completely anonymized. All direct identifying information (such as name, contact number, national code, address) has been removed from the original dataset and replaced with a random numeric code. The file linking these codes to the real identities of individuals will be kept separately and confidentially by the main researcher and will not be made available to others under any circumstances. When: The data from this study will be available for legitimate research requests 6 months after the acceptance and electronic publication of the first original article in a reputable journal. To whom: Access to this research dataset will be granted only to applicants who meet the following criteria: 1. Researchers and graduate students affiliated with an accredited academic or research institution. 2. The purpose of the request is to conduct non-commercial scientific research (such as a thesis, review article, meta-analysis, or research project). 3. A written request (official email) along with a brief research plan (Proposal) that clearly explains the goals, methods, and necessity of using these data has been submitted to the principal investigator. 4. Commit to using the data only for the purpose specified in the application and to refrain from any attempt to re-identify participants. 5. Commit to fully and appropriately citing the original source of the data (this thesis/article) in any publication resulting from these data. 6. Written consent from the principal investigator and, if necessary, re-approval from the ethics committee issuing the project has been received. Conditions: The data from this study may be used for scientific, research, and non-commercial purposes only. Permitted uses include: · Conducting secondary analyses to answer new research questions. · Conducting meta-analyses or systematic reviews. . Replication or validation of the findings of the original study. · Use as teaching data or samples in research methods courses (with confidentiality). Basic Terms and Conditions of Use: 1. Ethical commitment: The user undertakes to never use the data to identify or contact participants and to respect their privacy. 2. Use restrictions: The data must not be used for commercial, marketing, insurance, legal or any discriminatory purposes. 3. Indexing and Citation: Any publication (article, report, thesis) that uses these data is required to properly cite and mention the original source (including the trial registration number in IRCT and the original article/thesis). 4. Prohibition of transfer: The user does not have the right to transfer the data to a third party or upload them to another public repository, except with the written permission of the principal investigator. Where to obtain: Applicants for data access should send their formal request in the form of an email to the address of the author of this proposal. · Name and surname: Shabnam Rashidi · (Email): EstShaNur@gmail.com Required documents to accompany the email application: 1. A brief research proposal containing the title, objectives, methodology, and justification for the need for the data of this study. 2. A brief CV of the applicant. 3. A written commitment to comply with the conditions mentioned in this proposal (non-commercial purposes and confidentiality). How to obtain: The data access request will be processed through the following steps: 1. Submitting the initial request: The applicant sends a formal email containing the following to the designated contact point: · Self-introduction and institutional affiliation · Description of the research objective and scientific justification for the need for the data · Brief research proposal · Scientific CV Comments:
public Shabnam Rashidi
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Tohid Street
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 EstShaNur@gmail.com Tehran University of Medical Sciences scientific Shabnam Rashidi
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Tohid Street
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 EstShaNur@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Heart failure diagnosis: Patients must have been officially diagnosed by a specialist as having heart failure class 2 or 3 according to the New York Heart Association scale. Age: Patients must be within a certain age range (18 to 60 years). Physical fitness: Patients must be physically able to perform yoga exercises and breathing techniques and have no specific medical restrictions in this regard. Willingness to participate in the study: Patients must give their informed consent to participate in the study and be able to participate in the educational program for a specified period of time (7 weeks). Access to mobile phone and internet. Not taking sedatives or medications for sleep disorders on a regular basis. No history of myocardial infarction or recurrent angina within the past six months. No pregnancy or breastfeeding. No use of similar therapeutic methods: Patients must not have used similar methods, such as yoga or breathing techniques, for at least 3 months before the start of the study. 18 years 60 years Both Unwillingness to continue participating in the study. Exacerbation of the disease. Death of the patient. Not responding to more than ten percent of the questionnaire items. I50 Heart failure Rehabilitation Lifestyle Intervention group: Intervention group: The intervention included training and implementation of yoga breathing techniques (pranayama), in the form of daily 30-minute online sessions, on Google Meet and WhatsApp, for 7 weeks. The exercises used have been previously approved and content reviewed by yoga and Iranian medicine specialist Dr. Azadeh Zarei. The student researcher provides the training live and the patients practice simultaneously. If the movements are performed incorrectly, necessary corrections are made. Patient adherence is monitored through attendance at sessions and correct execution of the exercises. The intervention group is also given an educational booklet that includes an introduction to heart failure and yoga, scientific and safety basics, instructions for preparing the person and the environment, a description of breathing exercises, a weekly program with a monitoring chart, frequently asked questions, a final note, and a blank page for recording patient notes or symptoms. One week after the end of the intervention (7 weeks), in the eighth week, the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) and the Pittsburgh Sleep Quality Questionnaire (PSQI) will be completed again by the participants, and the results will be compared with pre-intervention data. The yoga exercises used in this study include the following: Naadi Shodhan Pranayam; Om Chanting; Ujjayi Pranayam; Bhramari Pranayam; Sheetali/Sheetkari; Yog Nidra in Shavasan Control group: Patients in the control group were advised usual heart failure care and standard treatment based on the 2017 AHA/ACC guidelines, including pharmacological interventions and lifestyle changes. Control group participants were encouraged to walk briskly for at least 40 minutes daily; limit alcohol and sodium intake; follow the DASH diet; avoid smoking; and continue their medication. Quality of life score in the World Health Organization Quality of Life Questionnaire Short Form (WHOQOL-BREF); Sleep quality score in the Pittsburgh Sleep Quality Index. Timepoint: In this study, sleep and quality of life are measured in two stages, once before the start of the intervention and before randomizing patients, and once a week after the end of the study. Method of measurement: World Health Organization Quality of Life Questionnaire Short Form (WHOQOL-BREF); Sleep quality score in the Pittsburgh Sleep Quality Index. Self-reported symptoms of heart failure patients, including shortness of breath, fatigue, cough, and daily activity tolerance. Timepoint: These outcomes are assessed in two time periods: once before the intervention begins and once a week after the intervention ends. Method of measurement: Self-report. Tehran University of Medical Sciences Approved 2025-12-27 Ethics Committee of the Faculty of Nursing and Midwifery and the Faculty of Rehabilitation - Tehran Dr. Mirkhani Street (East Nusrat), Towhid Square Tehran Tehran Iran (Islamic Republic of)