A single-blind, randomized controlled clinical trial will be conducted between August 2012 and March 2013. The aim of this study is to compare the effect of «PLISSIT model» with «Sexual Health model» in women with sexual problems in Tehran, Iran. Eighty-four women aged 20-45 years with history of sexual problem will be randomly allocated to receive either PLISSIT model intervention or Sexual Health model. The main outcome of the study, sexual function and sexual distress, will be measured respectively, with the Brief Index of Sexual Function for Women (BISF_W) and Female Sexual Distress Scale_ Revised (FSDS_R) questionnaires, at base line, 2.5 and 7 months post -intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206099975N1
Registration date:2012-09-11, 1391/06/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-11, 1391/06/21
Registrant information
Name
Farnaz Farnam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4217
Email address
fz.farnam@gmail.com
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled trial of effect of PLISSIT and Sexual Health models on women sexual problems
Public title
Effect of PLISSIT therapeutic model and Sexual Health model on women’s sexual problems
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of problem during the last 2 months, distress score > 11 , healthy women age 20 to 45 years, married and having an intact marriage.
Exclusion criteria: alcohol and other form of drug abuse, severe mental disorder such as depression and anxiety, chronic/acute medical disorders that affect on sexuality such as diabetes and heart disease
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization Scheme: A total of 84 women with history of sexual problems who meet the eligibility criteria, will be randomized into one of the groups. Subjects will be randomized according to a preexisting list produced by the computer program. First group will receive PLISSIT model and Sexual Health model will be implemented for the second group. Both groups will participate in six sessions. All enrolled subjects will be assessed for demographic characteristics, medical history, sexual function and sexual stress
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Third floor, Building number 4, Hezar jarib St., Isfahan University of Medical Sciences
City
Isfahan
Postal code
8144503500
Approval date
2012-05-27, 1391/03/07
Ethics committee reference number
391026
Health conditions studied
1
Description of health condition studied
Sexual problems
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Sexual distress
Timepoint
At baseline, 2 and 4 months post-intervention
Method of measurement
Female Sexual Distress Scale_Revised ( FSDS_R)
2
Description
Sexual function
Timepoint
At baseline, 2.5 and 7 months post- intervention
Method of measurement
Brief Index of Sexual Function for Women (BISF_W)
Secondary outcomes
empty
Intervention groups
1
Description
PLISSIT model (Permission, Limited Information, Specific Suggestions, Intensive Therapy) : The subjects in this group will receive five 60- minute therapy sessions. Sessions 1, 2, ۳, 4 and 5 are all adapted from the PLISSIT treatment model including four therapeutic stages. St1: Permission; client freely talks about her sexual concerns. Permission also is given to those non-problematic sexual behaviors which subject has already experienced. St2: Limited Information; therapist provides patient with limited information about the given problem. St3: Specific Suggestions; specific recommendations are offered enabling patient to manage her sexual problems. The fourth stage: Intensive Therapy; psycho-sexual therapy is performed by the researcher or Co-I psychiatrist. All subjects will be provided the five therapy sessions even if they might not need to receive intensive therapy. Researcher will be in contact with the subjects regularly to avoid missing follow up as well as addressing their concerns related to the therapy. Interventions for the subjects will be free of charge.
Category
Treatment - Other
2
Description
Sexual Health model: Second group will receive the gold-standard educational-based sexual health model. This Model includes 10 key components posited to be essential aspects of healthy human sexuality such as talking about sex, culture and sexual identity, sexual anatomy and functioning, sexual health care and safer sex, challenges to sexual health, body image, masturbation and fantasy, positive sexuality, intimacy and relationships, and spirituality. In this group subjects will attend in the five 60-minute group education sessions. Up to 10 women will be participating in each session.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeyni Hospital
Full name of responsible person
Farnaz Farnam
Street address
Family Health Clinic - Imam Khomeyni Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi; Vice-Chancellor for Research
Street address
Third floor, Building number 4, Hezar jarib St., Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Farnaz Farnam
Position
PhD candidate in Reproductive Health
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 912 242 3154
Fax
Email
fz.farnam@ gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan University of Medical Sciences, Tehran University of
Full name of responsible person
Farnaz Farnam, Mohsen Janghorban, Effate Merghati
Position
PhD candidate in Reproductive Health, Professor, Assistant Professor
Other areas of specialty/work
Street address
faculty of nursing and midwifery, Isfahan University of Medical Sciences- School of Public Health, Isfahan University of Medical Sciences; School of Public Health, Tehran University of Medical Sciences