Protocol summary

Summary
The purpose of this study was to evaluate the effectiveness of sexual skills training on intimacy and sexual satisfaction in women. Cluster clinical trial study was designed. The population of this study was group women who admitted to Shahid Beheshti university of Medical Sciences in Tehran’s health centers, 2014-15. This group was divided into two sub-groups of intervention (receiving education) and control group (without receiving education). The main criteria of individuals to be considered in the group were namely, the score of 30-40 in standard marital satisfaction according to the Enrich questionnaire, women with 6-24 months length of marriage (who lives together). The individuals were excluded from the study if did not meet the criteria, namely, not being present in more than 2 sessions of training sessions or pre-test and post-test, the occurrence of pregnancy during the study, occurrence of misadventure during the pre-test and post-test. Target sample size was 35 patients in each group, and totally 70 patients. Intervention time was one session for five consecutive weeks and then, the effect of the program was evaluated two months after the last training in two groups. The result of this study demonstrates that sexual skills training program improve intimacy and sexual satisfaction on women in intervention group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201412165667N4
Registration date: 2016-02-09, 1394/11/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-09, 1394/11/20
Registrant information
Name
Shahnaz Tork Zahrani
Name of organization / entity
Beheshti University of Medical Sciences & Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 8856 0717
Email address
zhrani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti university of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-05-05, 1394/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination the effect of sexual skills training, on promoting intimacy and sexual satisfaction in women receiving education compared to women without education
Public title
The effect of sexual skills training on intimacy and sexual satisfaction in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria includes: 1. Standard marital satisfaction score, between 30-40 and above according to the Enrich questionnaire, 2. Absence of classes or other training courses about sex in couples, 3. women with 6-24 months length of marriage (who lives together),4. Absence of abortion, dead fetus, not being pregnant, not having a child, 5. Not facing the death of loved ones in the last 6 months. 6. No acute or chronic Physical limitations known by the doctor, such as: depression, diabetes, obsessive-stress, addiction, rheumatoid arthritis in couples, 7. No alcohol dependence or psychotropic substances in couples 8. No drugs prescribed by a doctor during the past two years for couples 9. No history of pelvic surgery(internal and external), 10. Having at least primary education in couples, 11. Iranian couples, Exclusion criteria includes: 1. Lack of consent to continue participating in the study, 2. The absence of women in more than 2 sessions of training sessions or pretest and posttest, 3. The occurrence of pregnancy during the study, 4. Occurrence of misadventure during the pretest and posttest in women
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, health centers were selected using multistage selection. At the first round, the centers of Shahid Beheshti university of Medical Sciences were considered that were located at the Northeast, East and Southeast of Tehran. Two final centers were selected by considering just two centers in each geographical location that their volume and texture being more similar to each other in their clients, and finally the two centers, was allocated to each intervention and control groups randomly via coin toss method. Thus six centers were selected that three of them were considered to be the intervention group and other three remained centers were considered to be the control group. In fact, in each geographical location one center was considered to be the intervention group and another as control group randomly. Volunteers selected based on the convenient sampling.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti university of Medical Sciences
Street address
Arabee street, Yaman street, Shahid Chamran highway
City
Tehran
Postal code
Approval date
2014-12-07, 1393/09/16
Ethics committee reference number
SBMU.REC.1393.456

Health conditions studied

1

Description of health condition studied
The effect of sexual skills training on intimacy and sexual satisfaction
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction, not caused by organic disorder or disease

Primary outcomes

1

Description
Sexual satisfaction
Timepoint
Before intervention and two months after intervention
Method of measurement
Sexual satisfaction questionnaire (Larson)

2

Description
Intimacy satisfaction
Timepoint
Before intervention and two months after intervention
Method of measurement
Intimacy satisfaction questionnaire (shah Siah)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group received 5 weeks of sexual skills training using a training package. The training package contains six various components namely, classroom questioning, lecturing, presentations (using PowerPoint), training films, group discussion and asking-answering questions and review. The quality of the training package is accredited and confirmed using the opinions of ten experts. This training package is taught by a trained researcher in 90 minutes sessions per week for 5 weeks.
Category
Lifestyle

2

Description
No intervention for control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Torab Health Center
Full name of responsible person
Fatemeh Salehi moghaddam
Street address
Fakorian Alley, Shahid Kolahdooz street, Shariate Avenue
City
Tehran

2

Recruitment center
Name of recruitment center
Sheibani Health Center
Full name of responsible person
Fatemeh Salehi moghaddam
Street address
Hafez Alley, Shahid Kolahdooz street
City
Tehran

3

Recruitment center
Name of recruitment center
Nader Health Center
Full name of responsible person
Fatemeh Salehi moghaddam
Street address
Esfandane street, Jashnvareh Avenue, Tehranpars
City
Tehran

4

Recruitment center
Name of recruitment center
Kadoos Health Center
Full name of responsible person
Fatemeh Salehi moghaddam
Street address
Sajdee shomale street, Jashnvareh Avenue, Tehranpars
City
Tehran

5

Recruitment center
Name of recruitment center
Shobeir Health Center
Full name of responsible person
Fatemeh Salehi moghaddam
Street address
Behziste, khorasan Square, 17 shahrivar Avenue
City
Tehran

6

Recruitment center
Name of recruitment center
Safare Health Center
Full name of responsible person
Fatemeh Salehi moghaddam
Street address
Hadad adel street, Rey Avenue
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti university of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Arabee street, Yaman street, Shahid Chamran highway
City
Tehran
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, Shahid Beheshti 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
Shahid Beheshti university of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Position
Vice chancellor for research, Shahid Beheshti university of Medical Sciences
Other areas of specialty/work
Street address
Arabee street, Yaman street, Shahid Chamran highway
City
Tehran
Postal code
Phone
+98 21 2243 9781
Fax
Email
zarghi@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahnaz Tork zahrani
Position
Master of science in midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue
City
Tehran
Postal code
Phone
+98 21 8865 5366
Fax
Email
Zahranishahnaz@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Salehi moghaddam
Position
Master of science in midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue
City
Tehran
Postal code
Phone
+98 21 6655 3244
Fax
Email
fatemehsalehi28@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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