Menopause is one of the factors that can affect on sexual function. Many menopause women suffer from sexual dysfunction at this time. The purpose of the present study is the impact of Cognitive Behavior Therapy on Sexual function and satisfaction of post-menopausal women. This study is a single-case design (multiple baseline) according to the cognitive behavior therapy. The study samples are 4 post menopause women aged 50 to 65 with sexual dysfunction (score < 26 of FSFI questionnaire) and Lack of sexual satisfaction or low sexual satisfaction ( score <75 of Index of Sexual Satisfaction) that will select base on inclusion and exclusion criteria. To gather the data a demographic questionnaire, Female Sexual Function Index (FSFI) and Index of Sexual Satisfaction (ISS) will used. samples after determining baselines for the dependent variable will be entered for cognitive-behavioral therapy for 8 sessions of 90 minutes, with one session per week. All participants will complete Questionnaires in sessions 2, 4, 6 and immediately after treatment . In order to follow up, all women will re-evaluate two months after treatment, every 20 days.To analyze the data, visuals, Reliable change index (RCI) and percent recovery formulas will used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100324322N1
Registration date:2016-07-08, 1395/04/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-08, 1395/04/18
Registrant information
Name
Hajar Haghighi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 61 3367 5436
Email address
haghighi.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Development Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Cognitive Behavior Therapy on Sexual function and satisfaction among post-menopausal women
Public title
Efficacy of Cognitive Behavior Therapy on Sexual function and satisfaction among post-menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: menopausal women aged between 45- 60 year old (at least one year after amenorrea); married with stable life with her husband; first married; natural menopause; monogamy; FSFI<26; ISS<75; minimum education: diploma and accessible for 6 months.
Exclusion criteria: not having sex during the study; vaginal/ cervical/ pelvic infection( by examination); diagnosed psychological illness; history of sexual abuse or sexual harassment; addiction ( alcohol, drugs and other psychotropic drugs); occurrence of mishap events ( death, accidents with disabilities, treason, etc.) during the last 6 months; chronic diseases affect sexuality for menopausal women or her husband such as diabetes, cardiovascular disease, hypertension, cancer, vascular damage caused by accidents, thyroid disorders, spinal disorders, parkinson's disease, MS; the use of hormone replacement therapy (HRT) or topical estrogen for last 6 months.
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:
4
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Street address
Ahvaz- Golestan Blvd
City
Ahvaz
Postal code
61357-15749
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.AJUMS.REC.1394.240
Health conditions studied
1
Description of health condition studied
Menopause sexual dysfunction
ICD-10 code
N95.8
ICD-10 code description
Other specified menopausal and perimenopausal disorders
Primary outcomes
1
Description
Menopausal sexual function
Timepoint
Before intervention, during intervention, two months after intervention
Method of measurement
Female sexual function index (FSFI)
2
Description
Menopausal sexual satisfaction
Timepoint
Before intervention, during intervention, two months after intervention
Method of measurement
Female sexual function index (FSFI)
3
Description
Menopausal sexual distress
Timepoint
Before intervention, during intervention, two months after intervention
Method of measurement
Female sexual function index (FSFI)
Secondary outcomes
1
Description
Sexual desire in menopausal wemon
Timepoint
Before intervention, during intervention, two months after intervention
Method of measurement
Female Sexual Function Index
2
Description
Sexual arousal in menopausal wemon
Timepoint
Before intervention, during intervention, two months after intervention
Method of measurement
Female Sexual Function Index
3
Description
Sexual lubrication in menopausal wemon
Timepoint
Before intervention, during intervention, two months after intervention
Method of measurement
Female Sexual Function Index
4
Description
Orgasm in menopausal wemon
Timepoint
Before intervention, during intervention, two months after intervention
Method of measurement
Female Sexual Function Index
5
Description
Sexual satisfaction in menopausal wemon
Timepoint
Before intervention, during intervention, two months after intervention
Method of measurement
Female Sexual Function Index
6
Description
Sexual pain in menopausal wemon
Timepoint
Before intervention, during intervention, two months after intervention
Method of measurement
Female Sexual Function Index
Intervention groups
1
Description
Single case( multiple baseline), intervention will be held 8 sessions of 90 minutes according to researcher-made protocol based on cognitive behavioral therapy for every four participants held weekly.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Women's Clinic of Haj Azizi Hospital- Private obstetricians clinic
Full name of responsible person
Hajar Haghighi
Street address
Juibar, Qhaemshahr
City
Juibar, Qhaemshahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Mr Fatalizadeh
Street address
Ahvaz, Academic city. Research Committee of Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Hajar Haghighi
Position
Msc student of counseling in midwifery
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahwaz
Postal code
61357-15794
Phone
+98 611336754360
Fax
Email
haghighi.h@ajums.ac.ir; negar8606@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing & Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Dr. Parvin Abedi
Position
PhD in Community Nutrition, Associate Professor
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
parvinabedi@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hajar Haghighi
Position
MSc student
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahwaz
Postal code
Phone
Fax
Email
haghighi.h@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)