The aim of this study is to evaluate the efficacy of short-term treatment on unconsummated marriage as an experimental clinical trial with pre- and post-test. The target population will be 44 couples with the history of unconsummated marriage referred to the super specialty clinic of Tooloo in Rasht; they will be selected by administering the sexual satisfaction questionnaires to them and a clinical interview by a psychiatrist according to the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5). The minimum test scores for inclusion in the research will be ranged from 0 to 27 for men and from 0 to 36 for women. The couples with history of unconsummated marriage that the origin of their disease is not medical condition will be recruited by observation inclusion and exclusion criteria for the study by convenience sampling after obtaining the informed consent. Exclusion criteria would be any history of smoking; alcohol consumption or high body mass index. The treatment will be conducted during 5 sessions with the interval of one week. During the treatment, the skills including easy talking about sex, relaxation of genital muscles, cognitive restructuring, desensitization of anxiety will be taught. The efficacy obtained from the sexual satisfaction questionnaire will be evaluated one month later. The score above 28 for men and above 37 for women will confirm the efficacy of treatment.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016103021965N3
Registration date:2017-01-20, 1395/11/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-20, 1395/11/01
Registrant information
Name
Homa Zarrabi
Name of organization / entity
Guilan University of Medical Sceinces,«Kavosh » Cognitive Behaviour Sciences and Addiction Researc
Country
Iran (Islamic Republic of)
Phone
+98 13 3366 6268
Email address
shafakavosh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
University Of Medical Sciences Guilan,Vice chancellor for research
Expected recruitment start date
2016-06-20, 1395/03/31
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to evaluate the efficacy of short-term treatment for unconsummated marriage for sexual satisfaction
Public title
Clinical trial to evaluate the efficacy of short-term treatment for unconsummated marriage for sexual satisfaction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The couples with history of unconsummated marriage according to the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders(DSM-5); obtaining score between 0-27 for men and between 0-36 for women by the sexual satisfaction questionnaire; the participants would included in study if they have 18-64 years old without medical conditions; Exclusion criteria: psychiatric disorders; medicals consumption affecting sexual physiology; drugs or alcohol consumption, smoking cigarette and high body mass.
Age
From 18 years old to 64 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
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
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti Blvd,Opposite to the Sepah bank, Above Iran Radiator Representation. Building Of Assistance Research and Technology, Rasht, Iran
City
Rasht
Postal code
4193893345
Approval date
2016-06-14, 1395/03/25
Ethics committee reference number
IR.GUMS.REC.1395.76
Health conditions studied
1
Description of health condition studied
unconsummated marriage
ICD-10 code
F52
ICD-10 code description
Loss of sexual desire is the principal problem and is not secondary to other sexual difficulties, such as erectile failure or dyspareunia . Frigidity, Hypoactive sexual desire disorder
Primary outcomes
1
Description
sexual satisfaction
Timepoint
before the treatment and one month after the treatment
Method of measurement
sexual satisfaction questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: The treatment is conducted in five 45-minute sessions with one week interval and the skills of feeling comfortable to talk about sex the release of genital muscles cognitive restructuring and desensitization of anxiety will be taught.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tooloo Specialty and Subspecialty of Psychiatry Clinic of Rasht
Full name of responsible person
Dr kiomars Najafi
Street address
Shabnam alley, Golsar Crossroads, Opposite to the Municipal of Area (3),Rasht, Iran
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University Of Medical Sceinces Guilan,Vice chancellor for research
Full name of responsible person
Dr Rasool Tabari
Street address
Shahid Beheshti Blvd, Opposite to the Sepah Bank, above Iran Radiator Representation، Rasht, Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University Of Medical Sceinces Guilan,Vice chancellor for research