Determining the effect of Yoga techniques on quality of sexual life and sexual functioning of women after normal birth
Design
It's a clinical trial study which the participants will devided to two groups (n = 25). Before and 1,2 and 3 months after the intervention, their sexual function and sexual quality of life will measured by the FSFI and SQOL questionnaire. Women in the intervention group will be trained by yoga techniques for 60 minutes (twice a week for 3 months).
Settings and conduct
This study will be a clinical trial. Samples will be collected at health centers in Isfahan. In the intervention group, practical training of yoga techniques will be conducted twice a week for 3 months (twelve sessions in total). The sexual function and sexual quality of life will be assessed and the control group will be assessed monthly by telephone or face to face.
Participants/Inclusion and exclusion criteria
50 postpartum primiparous women who enter the study according to the characteristics of the research study.
Intervention groups
In the intervention group, practical training of yoga techniques will be conducted twice a week for 3 months (twelve sessions in total). These sessions will be held in 60-minute classes and the samples will be checked at the end of the first month At the end of the second month and also at the end of the third month, the questionnaire will assess sexual dysfunction and quality of life. The control group will also assessed monthly (before the start of the study, at the end of the first month, at the end of the second month, at the end of the third month) by a questionnaire by phone or face to face, and
after evaluation period a free yoga course for the control group will be conducted if they wish.
Main outcome variables
Sexual function
Sexual quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191023045221N1
Registration date:2019-12-21, 1398/09/30
Registration timing:prospective
Last update:2019-12-21, 1398/09/30
Update count:0
Registration date
2019-12-21, 1398/09/30
Registrant information
Name
farzaneh shadani
Name of organization / entity
Tarbiat modares university
Country
Iran (Islamic Republic of)
Phone
+98 31 3250 3609
Email address
farzaneh.shadani@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-06-04, 1399/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Yoga Techniques on Women’s Sexual Function and Sexual Quality of Life after vaginal delivery
Public title
The effect of yoga on women's sexual Function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women with normal delivery at reproductive age (15-45 years)
Starting sexual intercourse after delivery
Not having a known disease
Not having mental illness
Being single spouse and living with spouse now and during the study
Literacy of reading and writing Persian language
8-16 weeks after vaginal delivery
Being Iranian and resident in Isfahan
Having a healthy baby
Having exclusive breastfeeding with breast milk
Not-practicing yoga in control group
Exclusion criteria:
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be used for randomizing participants within blocks such that an equal number are assigned to treatment. in this study which given a block size of 4, there are 6 possible ways to equally assign participants to a block. Allocation proceeds by randomly selecting one of the orderings
and assigning the next block of participants to study groups according to the specified sequence
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 Tarbiat Modarres University
Street address
Jalal Al-Ahmad Highway, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
1919-10-23, 1298/07/30
Ethics committee reference number
IR.MODARES.REC.1398.145
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Measuring the female sexual function
Timepoint
Before the intervention, 1,2,3 months after the start of the intervention
Method of measurement
Female Sexual Function Index
2
Description
Measuring the female sexual quality of life
Timepoint
Before the intervention, 1,2,3 months after the start of the intervention
Method of measurement
The Sexual Quality of Life-Female (SQOL-F) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, practical training of yoga techniques will be conducted twice a week for 3 months (twelve sessions in total). These sessions will be held in 60-minute classes and the samples will be checked at the end of the first month At the end of the second month and also at the end of the third month, the questionnaire will assess sexual dysfunction and quality of life.
Category
Treatment - Other
2
Description
Control group: The control group will not manipulated and will assessed monthly (before the start of the study, at the end of the first month, at the end of the second month, at the end of the third month) by a questionnaire by phone or face to face, and after evaluation period a free yoga course for the control group will be conducted if they wish.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Health Centers
Full name of responsible person
Shadab Shahali
Street address
Khorasgan squar
City
Isfahan
Province
Isfehan
Postal code
8879125461
Phone
+98 31 3524 1613
Email
shadab.shahali@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Yaghob Fathollahi
Street address
Jalal Al-Ahmad Highway, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 82880
Email
pres@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat modares university
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
Tarbiat Modares University
Full name of responsible person
Shadab Shahali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Jalal Al-Ahmad Highway, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 3811
Email
shadab.shahali@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Shadab Shahali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Jalal Al-Ahmad Highway, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 3811
Email
shadab.shahali@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Farzaneh Shadani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No12.4darab alley.al khojand st.parvin st.
City
Esfahan
Province
Isfehan
Postal code
8199698841
Phone
+98 31 3250 3609
Fax
Email
farzaneh.shadani@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some of the main outcome data will be shared.
When the data will become available and for how long
Start access period from2021
To whom data/document is available
Researchers
Under which criteria data/document could be used
For research and after sending the request letter to corresponding author
From where data/document is obtainable
Corresponding author, Department of midwifery and reproductive health, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
What processes are involved for a request to access data/document
After receiving the request to the corresponding author, the request will be sent to the research unit of Tarbiat Modarres University and analyzed data will be provided to researcher