Determining the impact of mindfulness-based counseling on sexual function and body image in menopausal women
Design
The counseling intervention study has pre-test and post-test and has a control group and a sample size of 110 people who are divided into two intervention and control groups by a simple random method (lottery).there is no blinding
Settings and conduct
110 women between the ages of 45 and 60 who met the entry criteria after completing the sexual function and body image questionnaire in the clinics of Dilijan and obtaining the desired score were entered into the study and randomly divided into two intervention and control groups and the intervention group They will receive counseling based on the conscious mind for 8 weeks in 90 minute sessions and again the questionnaires will be completed immediately after the intervention and 2 months after the intervention by the women of both groups.
Participants/Inclusion and exclusion criteria
Postmenopausal women aged 45 to 60. Literacy. Iranian and residing in Delijan. Legally married and sexually active with spouse. Spouse residing in Delijan. Normal body mass index and overweight. Natural menopause. No alcohol and drug use and no severe marital conflict. No psychiatric and gynecological diseases and no sexual dysfunction in spouse. No genital and malignant surgery in the woman. And scoring less than 28 on the sexual function questionnaire.
Intervention groups
Postmenopausal women who meet the inclusion criteria will be randomly divided into intervention and control groups, and the intervention group will receive 8 weekly sessions of 90 minutes of mindfulness counseling, and the control group will receive routine menopause training.
Main outcome variables
The first outcome: sexual performance
The second consequence: body image
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241021063452N1
Registration date:2025-06-12, 1404/03/22
Registration timing:retrospective
Last update:2025-06-12, 1404/03/22
Update count:0
Registration date
2025-06-12, 1404/03/22
Registrant information
Name
tayyebe rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4425 0947
Email address
t.rostami@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-09-10, 1403/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based counseling on sexual performance and body image of menopause women
Public title
The effect of mindfulness-based counseling on sexual performance and body image of menopause women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women between the ages of 45 and 60
having experience to participate in the study
Iranian nationality and living in Dilijan.
Natural menopause
Reading and writing literacy
Being single and having sex with a spouse, being monogamous and having a permanent marriage.
The wife is employed in Dilijan city and the wife does not stay outside the city for a long time.
Body mass index in normal and overweight range,
The performance score according to the questionnaire is less than 28.
Exclusion criteria:
Absence of alcohol and drug use in a woman and her husband
And the absence of gynecological and mental diseases and the absence of dysfunction in the wife.
Absence of acute marital conflicts between couples.
and the absence of genital and malignant surgeries (uterus, ovaries, and breasts).
Failure to participate in similar counseling and treatment sessions during the last month.
Absence of an unfortunate event within 3 months before the study.
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Basij sq
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2024-06-16, 1403/03/27
Ethics committee reference number
IR.ARAKMU.REC.1403.123
Health conditions studied
1
Description of health condition studied
Sexual Function And Body Image
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual Function
Timepoint
Before intervention _Immediately after the intervention_Two months after the intervention
Method of measurement
Rozen Women's Sexual Performance Questionnaire
Secondary outcomes
1
Description
Body Image
Timepoint
Before intervention_Immediately after the intervention_Two months after the intervention
Method of measurement
Littleton's Body Image Fear Questionnaire
Intervention groups
1
Description
Intervention group: Mindfulness-based counseling sessions for the intervention group are held weekly for eight weeks
Category
Other
2
Description
Control group: Women in this group only receive routine menopause care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center of Dilijan city
Full name of responsible person
Tayyebe rostami
Street address
Fazel Naraghi Blvd.
City
Delijan
Province
Markazi
Postal code
3791145775
Phone
+98 86 4422 5012
Fax
Email
tayyebe.rostami@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Behzad Khansarinejad
Street address
Basij Sq
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
+98 86 3313 4766
Email
research@arakmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Arak university medical science
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
Arak University of Medical Sciences
Full name of responsible person
Tayyebe Rostami
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.28, Welayat Ave, Emamat Blv.
City
Delijan
Province
Markazi
Postal code
3791145775
Phone
+98 86 4425 0947
Fax
Email
t.rostami@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr fereshte farzan azar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid shirodi Ave
City
Arak
Province
Markazi
Postal code
3848176610
Phone
+98 86 3383 8602
Email
amozesh@arakmu.AC.IR
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Tayyebe Rostami
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
NO. 28, Welayat Ave, Emamat Blv,
City
Delijan
Province
Markazi
Postal code
3791145775
Phone
+98 86 4425 0947
Fax
Email
t.rostami@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available