The effect of counseling based on sexual self-efficacy on sexual function and sexual satisfaction in newly married women: a randomized controlled trial
Objective: to determine the effect of counseling on sexual function and sexual satisfaction in newly married women
Deign: randomized controlled trial.
Setting and conduct: this study will be conducted on newly married women covered by the premarital counseling center in Zanjan City. Researcher will be attended in premarital counseling center and listed contact number of couple who have been married previous six months to 3 years through health file. Then, they will be invited for participation in study through telephone call. After attending in the counseling center and completing consent form, the pretest questionnaires will be completed by self-administered method. Participants will be randomly assigned into two groups (one intervention group receiving sexual counseling and a control group) with block sizes of 4 and 6. A person from research team not involved in the sampling will generate allocation sequence.
Participants: 88 newly married women aged at 20 to 35 years old.
Intervention: Educational intervention based on social cognitive theory of Bandura will be provided for intervention group. An individual counseling (30 minutes per session) and five group counseling (90 minutes per session for eight small groups) will be carried out within six weeks (one session in each week) for intervention group.
Primary outcome variables include sexual function and sexual satisfaction and secondary outcome variables include sexual quality of life and sexual self-efficacy that will be evaluated before and eight weeks after intervention through questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121010324N26
Registration date:2016-01-23, 1394/11/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-23, 1394/11/03
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2016-03-15, 1394/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based on sexual self-efficacy on sexual function and sexual satisfaction in newly married women: a randomized controlled trial
Public title
The effect of counseling based on sexual self-efficacy on sexual function and sexual satisfaction in newly married women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: women aged at 20 to 35 years old; women married and living with spouse; having at least a high school education; having at least six months and a maximum of three-year experience of marital life; being interested in participating the study; marital monogamy; having the first experience of marriage; no pregnancy and lactation and no planning for pregnancy at least in the next 12 month; at least 7 years old age difference among couples.
Exclusion criteria: catching each of the spouses to certain physical diseases and mental disorders; medicine consumption that affect their sexual function (currently or within the last six months); husband 's addiction to drugs and psychotropic substances (according to wife ); changing location and being in trouble for participation; having experience of disaster during six-month age (death of a child or loved one, serious illness of a close relative, the prison sentences of one member of a family, experience of depression); unwanted marriage crisis ( divorce, wrath, long official mission); being relations of cousin, co-worker or neighbor between participants of intervention and control groups; forced marriage and Emotional divorce.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Postal code
Approval date
2015-11-30, 1394/09/09
Ethics committee reference number
54/9709
Health conditions studied
1
Description of health condition studied
Sexual function
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Sexual Function
Timepoint
Befor of intervention/ 8 weeks after end of intervention
Method of measurement
Female Sexual Function Index-FSFI
2
Description
Sexual Satisfaction
Timepoint
Befor of intervention/ 8 weeks after end of intervention
Method of measurement
Sexual Satisfaction Scale for Women
Secondary outcomes
1
Description
Sexual Quality Of Life
Timepoint
Befor of intervention/ 8 weeks after end of intervention
Method of measurement
Sexual Quality Of Life-Female- SQOL-F
2
Description
Sexual Self-efficacy
Timepoint
Befor of intervention/ 8 weeks after end of intervention
Method of measurement
Sexual Self-efficacy Scale
Intervention groups
1
Description
Educational intervention based on social cognitive theory of Bandura will be provided for intervention group. An individual counseling (30 minutes per session) and five group counseling (90 minutes per session for eight small groups) will be carried out within six weeks (one session in each week) for intervention group.
Category
Behavior
2
Description
The control will receive no intervention. If the results of research show the positive effect of counseling, the content of counseling as booklet will be provided for control group at the end of study.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Premarital Counseling Center
Full name of responsible person
Badrolmonir Safari
Street address
Health Center of Number 14
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
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, Tabriz 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
Nursing & Midwifery Faculty,Tabriz University of Medical Sciences
Full name of responsible person
Leila Alimohammadi
Position
Ms Student of Counseling in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz
City
Tabriz
Postal code
66156-15733
Phone
+98 41 3479 6770
Fax
Email
leilaalimohamadi23@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz
City
Tabriz
Postal code
Phone
+41 33357582
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Mohammad Masoud Vakili
Position
Ph.D of Health Education & Health Promotion
Other areas of specialty/work
Street address
Parvi Etesami avenue, College of Health, Department of Health Education & Health Promotion
City
Zanjan
Postal code
Phone
+98 24 3315 6394
Fax
Email
vakili@zums.ac.ir; vakili.mm@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)