Determining the effect of mindfulness on sexual dysfunction in women undergoing infertility treatments
Design
Clinical trial with control and random groups. On 42 people (in each group). 4-by-6 and 6-by-block blocking will be used for randomization.
Settings and conduct
Sampling will be done in infertility centers under the supervision of Iran University of Medical Sciences. The members of the intervention group will receive mindfulness sessions twice a week during 8 sessions of 30 minutes virtually (with university-approved social networks and live).
Participants/Inclusion and exclusion criteria
Entry condition: Be literate; Female age 18 to 45 years; Score less than 23 from the Women's Sexual Function Questionnaire; Non-smoking, substance abuse, alcohol and drugs that affect sexual function in couples; Lack of pelvic floor function disorders based on signs and symptoms
Non entry condition: Doubt about pregnancy; suspected symptoms of covid 19 in couples at the time of entering the study and 4 weeks before; Occurrence of stressful experiences 3 months before the study
Intervention groups
For each group, mindfulness sessions will be held twice a week for 8 30-minute sessions online (with university-approved social networks and live).
The control group will receive routine care.
Main outcome variables
The effect of mindfulness on sexual dysfunction in women undergoing infertility treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140823018903N3
Registration date:2022-08-20, 1401/05/29
Registration timing:registered_while_recruiting
Last update:2022-08-20, 1401/05/29
Update count:0
Registration date
2022-08-20, 1401/05/29
Registrant information
Name
Leila Neisani Samani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2846
Email address
nneysani@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness on sexual dysfunction in women undergoing infertility treatment under the supervision of Iran University of Medical Sciences
Public title
The effect of mindfulness on sexual dysfunction in women undergoing infertility treatment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be literate
Female age 18 to 45 years
Score less than 23 from the Women's Sexual Function Questionnaire
Non-smoking, substance abuse, alcohol and drugs that affect sexual function in couples
Lack of pelvic floor function disorders based on signs and symptoms
Having sex with your spouse during the last 6 months
Have sex at least once a week
Couples undergoing infertility medication
No history of female participation in mindfulness classes
No known disorders and mental illness
No known neurological disorders and diseases
The spouse does not have diabetes and other sexually transmitted diseases
Do not take drugs that affect mental and sexual function in couples
Monogamy
Exclusion criteria:
Absence from more than two sessions of mindfulness sessions
Being away from your spouse for more than a week for any reason while studying
Infection of covid19 in couples while studying
Occurrence of stressful experiences during the study
The need or request of the couple to continue the drug treatment with fertility supplements in the same treatment cycle
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by the method of 4 blocks with a ratio of 1:1, in this way, first we will form blocks of 4 for allocating the research units in the control and intervention groups with symbols A and B respectively, in such a way that a block of 4 from Through the table of random numbers in the order of A and B. Then, upon entering, each sample will be assigned to one of the A and B 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 Iran University of Medical Sciences
Street address
Tehran Hemat Highway next to Milad Tower، 14535
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-03-31, 1401/01/11
Ethics committee reference number
ir.iums.rec.1401.199
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determining the effect of mindfulness on sexual dysfunction in women undergoing infertility treatments
Timepoint
Before and one month after the intervention
Method of measurement
Female Sexual Function Index-FSFI
Secondary outcomes
empty
Intervention groups
1
Description
People in the intervention group receive mindfulness sessions in groups of 3-5 people for 8 sessions of 30 minutes.
Category
Treatment - Other
2
Description
receive routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility centers under the auspices of Iran University of Medical Sciences - Tehran
Full name of responsible person
Leila Nissan Samani
Street address
Tehran, Vali-e-Asr St., above Vanak Sq., Rashid Yasemi St., Iranian School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 4365 1000
Email
Neisani89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology, Iran University of Medical Sciences
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Leila Nissan Samani
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tehran, Vali-e-Asr St., above Vanak Sq., Rashid Yasemi St., Iranian School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
Neisani89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Nissan Samani
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tehran, Vali-e-Asr St., above Vanak Sq., Rashid Yasemi St., Iranian School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
Neisani89@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Nissan Samani
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tehran, Vali-e-Asr St., above Vanak Sq., Rashid Yasemi St., Iranian School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
Neisani89@gmail.com
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
There is no more information
Study Protocol
No - There is not 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
Individuals' personal social information will be kept strictly confidential and will not be disclosed.
When the data will become available and for how long
The access period will start immediately after the results are published in the journal.
To whom data/document is available
All students and researchers referring to databases
Under which criteria data/document could be used
The results of the research are available to all interested parties after the completion of the work in the form of an article in the journal
From where data/document is obtainable
databases
What processes are involved for a request to access data/document