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Comparison of the effect of Yoga and pelvic floor muscle exercises on the sexual function index and sexual self-esteem of reproductive age women

Protocol summary

Study aim
Comparison of the effect of combined yoga exercises versus pelvic floor muscle exercises on the index of sexual performance and sexual self-esteem of reproductive age women
Design
The clinical trial has a control group, community-based, with parallel groups, without blinding, randomized, on 60 research units, and for randomization, permutation block was used by Random Allocation software.
Settings and conduct
This study will be conducted on 60 married women of reproductive age of 20-54 years and working in Shahrekord University of Medical Sciences and affiliated centers. Qualified samples are selected in a cluster and entered into two study groups through randomization. Research data will be collected using a questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Reproductive age 20-54 years, first marriage, reading and writing literacy, no alcohol and drug addiction, living with spouse, living in Shahrekord, Absence of any known physical and mental illness, Not taking drugs that affect sexual performance - No history of surgery in genital and pelvic areas in couples. Exclusion Criteria: Unwillingness to participate in the study
Intervention groups
The intervention includes a yoga exercise program in the form of 2 sessions per week for 6 weeks (12 sessions in total) where each session lasts from 45 minutes in the first 4 weeks to about 75 minutes in the final weeks. For both the intervention and control groups, during a training session, the stages of the natural sexual cycle, a brief description of the role of the pelvic floor muscles and the correct way to exercise the pelvic floor muscles are will be taught.
Main outcome variables
Sexual performance index; sexual self-esteem

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100524004015N1
Registration date: 2023-10-23, 1402/08/01
Registration timing: registered_while_recruiting

Last update: 2023-10-23, 1402/08/01
Update count: 0
Registration date
2023-10-23, 1402/08/01
Registrant information
Name
Zeinab Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3334 1412
Email address
zeinab.tavakol@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Yoga and pelvic floor muscle exercises on the sexual function index and sexual self-esteem of reproductive age women
Public title
The effect of yoga and pelvic floor muscle exercises on sexual performance index and sexual self-esteem
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 20-54 First marriage Literacy for reading and writing Absence of alcohol and drug addiction Living with a spouse Living in Shahrekord city Absence of any known underlying physical and mental illness No history of pregnancy and breastfeeding No self-reported sexual abuse Not taking drugs that affect sexual function (diuretics, sympatholytics, alpha blockers, beta blockers, antipsychotics, antidepressants, histamine receptor blockers, gonadotropin-releasing hormone agonists, OCPs) Absence of known sexual function disorders in couples No history of surgery in genital and pelvic areas in couples
Exclusion criteria:
Unwillingness to participate in the study
Age
From 20 years old to 54 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the samples to two intervention and control groups, tables of 6 blocks (table of random numbers) will be used. In this way, a number is included for the names of the registered people, then using 6 block tables and random allocation software, these numbers are randomly placed in one of the two groups.
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 Shahrekord University of Medical Sciences
Street address
Rahmatiye
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2023-08-15, 1402/05/24
Ethics committee reference number
IR.SKUMS.REC.1402.061

Health conditions studied

1

Description of health condition studied
Sexual self-esteem
ICD-10 code
ICD-10 code description

2

Description of health condition studied
sexual performance index
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual performance index: in classified sexual activity, if the score obtained from the questionnaire is equal to 36, sexual performance is good, 29 to 32 is average, and less than 23 is poor.
Timepoint
Before the intervention, immediately after the end of the intervention, one month after the end of the intervention
Method of measurement
Sexual function index questionnaire (FSFI)

2

Description
Sexual self-esteem: by adding the scores of 5 areas of sexual self-esteem, the total score of the scale is obtained, and a higher score indicates a higher sexual self-esteem. Cronbach's alpha coefficient was reported as 0.92 for the whole scale, 0.84 for skill and experience, 0.88 for attractiveness, 0.80 for control, 0.80 for moral judgment, and 0.80 for conformity.
Timepoint
Before the intervention, immediately after the end of the intervention, one month after the end of the intervention
Method of measurement
Sexual satisfaction questionnaire (SSEI-W-SF).

Secondary outcomes

empty

Intervention groups

1

Description
In addition to performing pelvic floor muscle exercises at home, the intervention group will participate in a 12-session exercise program designed by a yoga instructor and researcher in one of the clubs affiliated to Shahrekord University of Medical Sciences. The yoga exercise program is carried out as 2 sessions per week for 6 weeks, with each session lasting from 45 minutes in the first 4 weeks to 75 minutes in the final weeks, with varying degrees of intensity. The training program in each session includes three parts: warm-up movements (Pawan Moket), Salam Barkhorshid cycle, main cycle movements (Asana) and cooling and relaxation (Shavasana). Exercises start from a low level and progress gradually. If necessary, the selected exercises are adjusted for the subjects who are not able to maintain their posture while doing it, and in this way, the principle of paying attention to the individual differences of the subjects is respected. In order to overload principle, the repetition of movements in each session increases compared to the previous session. At the beginning of each session, for 15-20 minutes, we will have warm-up exercises for joints and muscles (Pawan Moket). These warm-up exercises include 3 general categories of movements: joint warm-up, core muscle warm-up and movements related to unblocking energy pathways. Then 10 minutes of the exercise are dedicated to the sun salutation cycle. The movements related to this cycle include stretching, strength, balance, contraction and inversion movements. After performing the sun salutation cycle, the movements of the main cycle (asana) designed by the yoga instructor are performed in a period of 20 minutes. Finally, 10 to 15 minutes are considered at the end of the workout for cooling down and relaxation movements (Shavasana).
Category
Lifestyle

2

Description
Control group: Control group only do pelvic floor muscle exercises at home. It is worth noting that the subjects of both the intervention and control groups are fully trained on how to perform this pelvic floor muscle exercise at home during a joint briefing before random assignment.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord University of Medical Sciences and all affiliated health centers
Full name of responsible person
Narges Sadat Tabatabaie
Street address
Rahmatiye
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 1214
Email
nstj1372@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Elham Raeisi
Street address
Rahmatiye
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
Raeisi.e@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Zeinab Tavakol
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Rahmatiye
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 1412
Email
zeinab.tavakol@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Zinab Tavakol
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Rahmatiye
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 1214
Email
zeinab.tavakol@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Narges Sadat Tabatabaie
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Rahmatiye
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 1214
Email
nstj1372@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
All study data including demographic information, sexual self-esteem status and sexual performance index before and after the intervention can be published.
When the data will become available and for how long
Only after publishing the article extracted from this data can be published.
To whom data/document is available
Researchers related to the research field
Under which criteria data/document could be used
In order to generalize the results of the research, after the publication of the article, if the researcher has a convincing reason to use the data and undertakes to refer to the information of this research.
From where data/document is obtainable
Send your request to the responsible person's email.
What processes are involved for a request to access data/document
Email request.
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