Protocol summary

Summary
This study aims to determine the effect of acceptance and commitment-based counseling on sexual performance and satisfaction in young couples compared to the conventional counseling currently provided in premarital counseling centers. This clinical trial with control and case groups will be conducted with 60 couples, selected purposively if they meet the inclusion criteria, and then randomly and evenly divided into control and case groups (30 each). Intervention is conducted in three stages. Each stage will include 20 couples in control and case groups, who will receive conventional and commitment-based premarital counseling respectively. After completion of educational sessions, the results of sexual satisfaction and function questionnaire completed by both control and case groups will be compared. Study inclusion criteria are the following: minimum high school diploma education, 20-30 years old, and couples planning to live together in the next two weeks. Study exclusion criteria are the following: unwillingness to participate due to personal reasons, illness, or a disorder that prevents individuals from attending educational sessions. Interventions will comprise eight two-hour sessions. The first six sessions will involve commitment-based group counseling for both men and women, and in the last two sessions, sexual relationship will be taught to men and women separately. In this study, the sexual function and satisfaction intervention will be provided through commitment-based counseling, with sexual function and satisfaction as the main outcomes.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015030721357N1
Registration date: 2016-01-18, 1394/10/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-18, 1394/10/28
Registrant information
Name
Pelinoos Ramezannezhad
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
p.ramezannejad@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acceptance and commitment-based counseling compared to traditional counseling provided in premarital counseling centers on sexual performance and satisfaction in young couples
Public title
The effect of premarital counseling on sexual satisfaction and performance
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The couples who refer to the consulting centers in Isfahan before marriage؛ Minimum education shall be high school certification؛ They shall not have acute psychological personal disorders (using general health questionnaire and maximum score of 36)؛ Non-attendance in sexual training classes before entrance into the classes for premarital consulting؛ Age group 20 to30 years؛ without any previous marriage؛ The couple that it has been determined to begin their mutual life within 2 weeks؛ The couple that live independently in a private house Exclusion criteria: non- cooperation due to existence of personal reasons or disease or a disorder that causes the person does not attend in the sessions.
Age
From 20 years old to 30 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization by coin toss will be conducted by

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht Avenue, Basij Square, Arak, Markazi
City
Arak
Postal code
38481-7-6941
Approval date
2015-08-03, 1394/05/12
Ethics committee reference number
IR.MUI.REC.1394.2.077

Health conditions studied

1

Description of health condition studied
Councelling sex
ICD-10 code
Z70.8
ICD-10 code description
Sex education

Primary outcomes

1

Description
Sexual satisfaction, Sexual function
Timepoint
A month after the intervention
Method of measurement
Questionnaire sexual function (FSFI) in women and men, Questionnaire sexual satisfaction Meston and Trapnel (SSS-W) in women,Questionnair Larson in men

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention group 1: 8 sessions of 2 hour class, which includes 6 sessions and two sessions of counseling based on acceptance and commitment sex education classes twice a week for a month
Category
Lifestyle

2

Description
Control group:Participants in the training course Premarital Counseling
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Gole Yas premarital counselling center
Full name of responsible person
Pelinoos Ramezannezhad,senior student of consultation in midwifery
Street address
Nabavimanesh Street, Atashgah Street, Isfahan,Gole Yas counselling center
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Arak University of Medical Sciences
Full name of responsible person
Mhammad Rafiee
Street address
Sardasht Avenue, Basij Square, Arak, Markazi
City
Arak
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,Arak 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
Arak University of Medical Sciences
Full name of responsible person
Naimeh Torkestani,
Position
Master education midwifery,teacher,University of Medical Sciences,School of Nursi
Other areas of specialty/work
Street address
Sardasht Avenue, Basij Square, Arak, Markazi
City
Arak
Postal code
38481-7-6941
Phone
+98 86 3417 3502
Fax
Email
tnaimeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
arak university of medical sciences
Full name of responsible person
Naimeh Torkestani,
Position
Master education midwifery,teacher,University of Medical Sciences,School of Nursi
Other areas of specialty/work
Street address
Sardasht Avenue, Basij Square, Arak, Markazi
City
Arak
Postal code
38481-7-6941
Phone
+98 86 3417 3502
Fax
Email
tnaimeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Pelinoos Ramezannezhad
Position
Senior student of consultation in midwifery
Other areas of specialty/work
Street address
Morvarid Complex ، Tohid Blvd ، Sepahanshahr ، Esfahan
City
Esfahan
Postal code
Phone
+98 31 3650 6139
Fax
Email
p.ramezannejad@arakmu.ac.ir
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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