Protocol summary

Study aim
Educational, Counseling
Design
Clinical trial with control group, with parallel groups, blind, randomized
Settings and conduct
Gonbad-e Qabus
Participants/Inclusion and exclusion criteria
Entry requirements: Reproductive age, passing through at least one year from the date of marriage, the first marriage of a woman, the absence of a mental or chronic disability, diploma and higher education, the stability of the social and economic situation (for example, failing to bankrupt and not economic problem, lack of person Disability or disability in the family, close relatives), full physical and mental health, living in an independent home, no surgery related to uterus and ovarian exodus, lack of alcohol and drugs, non-passing classes in communication skills and religion Shiite; Conditions of non-arrival: Cancellation of the company for any reason, pregnancy, a chronic disease and change Location Solution
Intervention groups
Women have sexual dysfunction
Main outcome variables
Marital Satisfaction; Sexual Desire; Communication Skills

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170701034835N1
Registration date: 2018-06-07, 1397/03/17
Registration timing: retrospective

Last update: 2018-06-07, 1397/03/17
Update count: 0
Registration date
2018-06-07, 1397/03/17
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3334 2917
Email address
m.alizade@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-05, 1396/07/13
Expected recruitment end date
2017-11-15, 1396/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cognitive Behavioral Therapy-based Film consulting impact on Communication Skills and Marital Satisfaction in Women with decreased Sexual Desire.
Public title
The effect of Cognitive
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Loss of libido
Exclusion criteria:
Cancellation of the participation in the study for any reason Pregnancy Contracting a chronic illness Changing the location
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
The method of this research is randomized research with pretest-posttest design, follow-up with the control group. First, sampling will be done using available sampling method to know the percentage of women who have decreased sex drive. According to related studies, the appropriate volume for sampling 300 people is determined (46-43). 300 women referred to centers and centers of health centers in Gonbad-e-Kavus city have been selected to have inclusion criteria after explaining about Research and written consent from them will be interviewed for them. So that for the 300 eligible women, the ASEX Sexual Desire and Sexuality Questionnaire will be used to measure sexual desire, and a score of less than 14 will be considered as a reduction in libido, and thus the percentage of women with reduced sexual desire It is determined. Then, 50 women who were approved for the reduction of libido were randomly selected and randomly assigned to two experimental groups (25 women) and control (25 women). In the first phase, the Afrooz marital satisfaction questionnaire and the communication skills of the women Runs (pre-test). 7 rings of cinematic films released in media with family background, which will be prioritized by expert advisor (Dr. Owhadi), who will be active in this field. The film will be provided by the researcher to the number required in several series.
Blinding (investigator's opinion)
Double blinded
Blinding description
For this purpose, the ASEX sexual desire and sexuality questionnaire is used to assess the sexual desire of 300 married women referred to the centers and health centers. A score of less than 14 will be considered as a reduction in libido. And according to the number of confirmed cases of decreased libido, the percentage of women with reduced sexual desire is determined. Then, 50 women with reduced sexual desire were selected and randomly selected and will be replaced in two groups (25 women) and control (25 women). At the first stage, Afrooz marital satisfaction questionnaire and communication skills of the women will be performed on women. (Pre-test). 7 rings of cinematic films released in media with family background, which will be prioritized by expert advisor (Dr. Owhadi), who will be active in this field. The film will be provided by the researcher to the number required in several series.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
4971867699
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
ir.arakmu.rec.1396.43

Health conditions studied

1

Description of health condition studied
Other sexual dysfunction, not caused by organic disorder or disease
ICD-10 code
f52.8
ICD-10 code description
Other sexual dysfunction not due to a substance or known physiological condition

Primary outcomes

1

Description
Communication Skills
Timepoint
Before intervention-After intervention
Method of measurement
JARABAK Communication Skills Questionnaire

Secondary outcomes

1

Description
Marital Satisfaction
Timepoint
Before intervention-After intervention
Method of measurement
Afrooz Marital Satisfaction Questionnaire

Intervention groups

1

Description
Intervention group: In this group, seven films each week are provided with a video footage from the intervention group to be seen at home and ask individuals to write their own thoughts and comments on the film in a few lines. After seeing each film, a meeting will be held with the participation of the research team and the test group.
Category
Other

2

Description
Control group: There was no intervention in the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers
Full name of responsible person
Mahnaz alizadeh
Street address
Taleghanee
City
Gonbad-e Qabus
Province
Golestan
Postal code
4971867699
Phone
+98 17 3328 8535
Email
m.alizade@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Mohammad Rafiee
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
4971867699
Phone
+98 86 3417 3463
Fax
+98 86 3417 3463
Email
mw.alizadeh94@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mahnaz Alizadeh
Position
Msc student in consultation midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
4971867699
Phone
+98 86 3417 3463
Fax
+98 86 3417 3463
Email
m.alizade@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Naimeh Akbari Torkestani
Position
University professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
4971867699
Phone
+98 86334173463
Fax
+98 86 3417 3463
Email
tnaimeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahnaz Alizadeh
Position
Msc student in consultation midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
4971867699
Phone
+98 17 3334 2917
Fax
+98 17 3323 7643
Email
mw.alizade94@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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