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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

Protocol summary

Study aim
Comparative evaluation of the Effects of Hatha Yoga exercise and Benson Relaxation on Sleep Quality in Postmenopausal Women with COVID-19
Design
Clinical trial with control group, with parallel, randomized groups, 99 children
Settings and conduct
Approval of the research plan in the university ethics committee. At the beginning of the study, complete the demographic characteristics checklist and the Pittsburgh Sleep Quality Index. Intervention Group 1: Cold Spray: Interventions will be conducted according to the protocol, over 8 sessions, each lasting 1 hour, with 1 session per week, for a total of 8 weeks. Intervention Group 2: Acupressure: Interventions include 8 sessions, each lasting 1 hour, with 1 session per week, conducted over a total of 8 weeks according to the protocol. After completing the interventions, the Pittsburgh Sleep Quality Index will be completed again. The interventions will take place in a room at the women's clinic to ensure privacy and comfort for the participants.
Participants/Inclusion and exclusion criteria
Admission requirements: Age 45 years and older. Conditions of non-entry: Severe underlying diseases, such as heart diseases, type 1 diabetes, or psychiatric disorders.
Intervention groups
Intervention Group 1: Hatha Yoga Exercise: In this group, participants will first be placed in the Shavasana (corpse) pose for 10 minutes, during which mind control techniques will be taught. Then, they will perform light exercises for 30 minutes. Intervention Group 2: Benson Relaxation: In this group, the Benson relaxation method will be taught to participants in a single 60-minute group session held in person. Control group: non-intervention: this training group will not be given.
Main outcome variables
The Pittsburgh Sleep Quality Index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200107046044N6
Registration date: 2025-06-10, 1404/03/20
Registration timing: prospective

Last update: 2025-06-10, 1404/03/20
Update count: 0
Registration date
2025-06-10, 1404/03/20
Registrant information
Name
Mohammadsajjad Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5242 1065
Email address
sajjad.mousavi2512@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-23, 1404/05/01
Expected recruitment end date
2025-11-01, 1404/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
A Comparative of the Effects of Hatha Yoga exercise and Benson Relaxation on Sleep Quality in Postmenopausal Women with COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 99
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2025-04-23, 1404/02/03
Ethics committee reference number
IR.YUMS.REC.1404.011

Health conditions studied

1

Description of health condition studied
Coronavirus 2019 (Covid-19)
ICD-10 code
u07.1
ICD-10 code description
U07.1: COVID-19, Virus identified

Primary outcomes

1

Description
Sleep quality score from the Pittsburgh Sleep Quality Index
Timepoint
Before and after the interventions
Method of measurement
The Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Lifestyle

2

Description
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.
Category
Lifestyle

3

Description
Control group: non-intervention: There will be no intervention in this group.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
MohammadSajjad Mousavi
Street address
Imam Sajjad Hospital, Next to Hotel Azadi, Yasuj, Kohgiloyeh and Boyerahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
6354169401
Phone
+98 74 3222 0163
Email
sajjad.mousavi2512@gmail.com

2

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
MohammadSajjad Mousavi
Street address
Shahid Beheshti Hospital, Shahid Montazeri Ave., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 1813
Fax
+98 74 3322 1811
Email
beheshtihospital@yasooj.ir

3

Recruitment center
Name of recruitment center
Martyr Dr. Jalil Hospital
Full name of responsible person
MohammadSajjad Mousavi
Street address
Martyr Dr. Jalil Hospital, Qarani Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7001
Email
sajjad.mousavi2512@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Cirruse Salehnasab
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
nursing@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
MohammadSajjad Mousavi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran
City
Bandar-e-Mahshahr
Province
Khouzestan
Postal code
6354169401
Phone
+98 61 5242 1065
Email
sajjad.mousavi2512@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
MohammadSajjad Mousavi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran
City
Bandar-e-Mahshahr
Province
Khouzestan
Postal code
6354169401
Phone
+98 61 5242 1065
Email
sajjad.mousavi2512@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
MohammadSajjad Mousavi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran
City
Bandar-e-Mahshahr
Province
Kohgilouyeh-va-Boyrahmad
Postal code
6354169401
Phone
+98 61 5242 1065
Email
sajjad.mousavi2512@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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