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IRCT20200107046044N6 IRCT 2025-06-10 Yasouj University of Medical Sciences A Comparative of the Effects of Hatha Yoga exercise and Benson Relaxation on Sleep Quality in Postmenopausal Women with COVID-19 A Comparative of the Effects of Hatha Yoga exercise and Benson Relaxation on Sleep Quality in Postmenopausal Women with COVID-19: A randomized controlled trial Study 2025-07-23 anticipated 99 Complete https://irct.ir/trial/84145 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block random assignment will be done in such a way that according to the number of study groups (three groups) consisting of intervention 1 (Hatha Yoga), intervention 2 (Benson Relaxation) and control and calculated based on the factorial law, i.e. 3!= 3×2×1= 6, all the possible arrangement modes of people will be compiled based on the table below, considering A for intervention group 1 (Hatha Yoga), B for intervention group 2 (Benson Relaxation) and C for control group: 1 2 3 4 5 6 ABC ACB BAC BCA CAB CBA Then, since the estimated sample size was 99 people, in each block, three samples, each representative of a study group and their arrangement order was also different, from these blocks, placement sampling will be done. After the study objectives are fully explained, eligible research samples will be selected and, based on the time priority of referral, each of them will be assigned a code. By matching that number with the block random allocation list, the patients participating in the study will be assigned to one of the intervention 1 (Hatha Yoga), intervention 2 (Benson Relaxation), and control groups. This process will continue until the estimated sample size is completed. N/A Coronavirus 2019 (Covid-19). Intervention 1: Intervention Group 1: Hatha Yoga Exercise: In this group, during the initial sessions, the researcher along with the instructor will first place the participants in the Shavasana (corpse) pose for 10 minutes and teach mind control techniques. Then, for 30 minutes, participants will perform light exercises including 4 movements in the lying position, 4 movements in the seated position, and 4 movements in the standing position. An important point is that after each movement, mindful attention to the limbs and breathing will be practiced. In all three positions, physical exercises will be combined with breathing exercises and relaxation techniques. Over subsequent sessions, the exercises will progress and increase from beginner to intermediate levels. The exercise program will be adjusted and conducted at least one to two hours after breakfast or a light lunch, at home, on a yoga mat or at minimum a quiet place with a soft carpet, in a moderate climate (neither cold nor hot). The interventions include 8 sessions, each lasting 1 hour, with 1 session per week, conducted over a total period of 8 weeks according to the protocol. Intervention 2: Intervention Group 2: Benson Relaxation:In this group, initially, the Benson relaxation method will be taught to the participants in a single 60-minute group session held in person. Then, the interventions will be carried out according to the protocol. The interventions include 8 sessions, each lasting 1 hour, with 1 session per week, conducted over a total period of 8 weeks according to the protocol. Intervention 3: Control group: non-intervention: There will be no intervention in this group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available.
public MohammadSajjad Mousavi
Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran
Bandar-e-Mahshahr Iran (Islamic Republic of) 6354169401 +98 61 5242 1065 sajjad.mousavi2512@gmail.com Ahvaz University of Medical Sciences scientific MohammadSajjad Mousavi
Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran
Bandar-e-Mahshahr Iran (Islamic Republic of) 6354169401 +98 61 5242 1065 sajjad.mousavi2512@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Ability to communicate and respond to the questions of the Pittsburgh Sleep Quality Index Age 45 years or older Consent to participate in the study and signing the informed consent form Having had COVID-19 during the recovery or convalescence period Scoring 5 or higher on the Pittsburgh Sleep Quality Index Not using sleeping medications No prior training or participation in studies similar to the current research within the past 6 months 45 years no limit Female Lack of willingness to participate in the study Not meeting the study inclusion criteria Severe underlying diseases, such as heart diseases, type 1 diabetes, or psychiatric disorders Physical or mental disability; individuals who are unable to perform yoga or relaxation exercises due to their physical or mental condition u07.1 U07.1: COVID-19, Virus identified Lifestyle Lifestyle Lifestyle Intervention Group 1: Hatha Yoga Exercise: In this group, during the initial sessions, the researcher along with the instructor will first place the participants in the Shavasana (corpse) pose for 10 minutes and teach mind control techniques. Then, for 30 minutes, participants will perform light exercises including 4 movements in the lying position, 4 movements in the seated position, and 4 movements in the standing position. An important point is that after each movement, mindful attention to the limbs and breathing will be practiced. In all three positions, physical exercises will be combined with breathing exercises and relaxation techniques. Over subsequent sessions, the exercises will progress and increase from beginner to intermediate levels. The exercise program will be adjusted and conducted at least one to two hours after breakfast or a light lunch, at home, on a yoga mat or at minimum a quiet place with a soft carpet, in a moderate climate (neither cold nor hot). The interventions include 8 sessions, each lasting 1 hour, with 1 session per week, conducted over a total period of 8 weeks according to the protocol. Intervention Group 2: Benson Relaxation:In this group, initially, the Benson relaxation method will be taught to the participants in a single 60-minute group session held in person. Then, the interventions will be carried out according to the protocol. The interventions include 8 sessions, each lasting 1 hour, with 1 session per week, conducted over a total period of 8 weeks according to the protocol. Control group: non-intervention: There will be no intervention in this group. Sleep quality score from the Pittsburgh Sleep Quality Index. Timepoint: Before and after the interventions. Method of measurement: The Pittsburgh Sleep Quality Index. Yasouj University of Medical Sciences Approved 2025-04-23 Ethics committee of Yasuj University of Medical Sciences Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)