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Effectiveness of the Sexual Health Education Program on the Sexual Self Efficacy, Marital Adjustment and Intimacy of Infertile Women

Protocol summary

Study aim
Determine the Effectiveness of the Sexual Health Education Program on the Sexual Self Efficacy, Marital Adjustment and Intimacy of Infertile Women
Design
A randomized, controlled, clinical trial, with parallel groups, single blind that a total of 60 subjects will assign to in a 1:1 ratio into two groups of 30, including a intervention group, and a control group. interventions by Computer-aid randomization.Sample size was calculated as 24 subjects in each group to yield an 80% power with 95% Confidence level, accuracy = 10.5, and approximate standard deviation (SD) = 13.01 based on previous studies for each group. After consideration of subjects dropping out of the research (30%), a total of 60 eligible infertile women will select in equal 2 groups (30 person in each group).
Settings and conduct
This study will conduct at Fatemeh Zahra Infertility and Reproductive Health Center of Babol University of Medical Sciences in Babol, Iran. The blind will be designed in terms of the analyzer, and by giving code to the groups, the nature of the groups for the analyzer is not known.
Participants/Inclusion and exclusion criteria
Satisfactory informed consent to the study  Infertility women who did not want to treat infertility until two months later.  Duration of infertility for more than 1 year  The ability to read and write at least  Have a lasting sexual activity (at least four weeks)  The availability of the spouse  Permanent marriage  Failure to participate in completing the questionnaire  Failure to answer more than 10% of the questionnaire questions  Having psychological support
Intervention groups
The intervention group will participate in a total of four two-hour group sessions of sex education and relaxation training . The control group will receive routine center counseling.
Main outcome variables
sexual self-efficacy, adjustment and marital intimacy

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20190203042601N1
Registration date: 2019-04-10, 1398/01/21
Registration timing: registered_while_recruiting

Last update: 2019-04-10, 1398/01/21
Update count: 0
Registration date
2019-04-10, 1398/01/21
Registrant information
Name
Sara Banaha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2247 3446
Email address
sara.banaha20@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-30, 1398/01/10
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of the Sexual Health Education Program on the Sexual Self Efficacy, Marital Adjustment and Intimacy of Infertile Women
Public title
Effectiveness of the Sexual Health Education Program on the Sexual Self Efficacy, Marital Adjustment and Intimacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
 Conscious consent to enter the study  Infertility women who did not want to treat infertility until two months later.  Duration of infertility for more than 1 year  The ability to read and write at least  Have a lasting sexual activity (at least four weeks) Age of at least 20 and maximum 40 years  The availability of the spouse  Permanent marriage  Consumers of drugs that cause sexual dysfunction, such as barbiturates, benzodiazepines (diazepam, oxazepam, chlordiazepoxide), antidepressants, antihypertensive drugs, etc.
Exclusion criteria:
 Failure to participate in completing the questionnaire  Failure to answer more than 10% of the questionnaire questions  Having psychological support (participating in psychotherapy sessions, relaxation techniques, yoga, etc.) An experienced stressful event in the last three months (death or acute illness of close relatives, a major change in lifestyle)With the above criteria, 60 infertile women enter the study and will be randomly assigned to experimental and control groups.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 60 infertile eligible women will be selected in two equal groups (30 women in each group). Random assignment will be provided by simple random allocation to provide the possibility of unpredictability of intervention unauthorized access. To generate a random assignment sequence from the computerized software program   Random allocation will be used to generate random sequences. Random assignment method using randomized computer software as Roandom smple of cases It will be in two equal categories (Approximately 50% of all cases)
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer (evaluator of outcome).
Placebo
Not used
Assignment
Parallel
Other design features
no

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
ganjafrouze street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.235

Health conditions studied

1

Description of health condition studied
sexual self efficacy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual Self Efficacy
Timepoint
Before the intervention and four weeks after its.
Method of measurement
Sexual self-efficacy measurement tool is a standard self-efficacy questionnaire.

2

Description
Marital Adjustment
Timepoint
Before the intervention and four weeks after its.
Method of measurement
Marital adjustment will measure using Graham-bi spinner Marital Adaptation Inventory (DAS: Dyadic Adjustment Scale).

3

Description
Marital Intimacy
Timepoint
Before the intervention and four weeks after its.
Method of measurement
Marital intimacy will measure using Marital Intimacy Needs Questionnaire Bagarozzi (2001( (MINQ).

Secondary outcomes

1

Description
sexual function
Timepoint
Before the intervention and four weeks after its.
Method of measurement
Iranian Version of the Female Sexual Function Inventory (IV-FSFI).

Intervention groups

1

Description
Intervention group:The intervention group will participate in a total of four two-hour group sessions of sex education and relaxation training will present in the form of lectures, Q&A, group discussions, booklets and CD.
Category
Behavior

2

Description
Control group: The control group will not receive any interventions. They will receive only routing consoling of center. To observe the ethics of research, the members of the control group will refer to a sex therapy clinic at the end of the four-week trial and educational package will given to them.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Zahra Infertility and Reproductive Health Center of Babol University of Medical Sciences in
Full name of responsible person
Sara Banaha
Street address
Babol,Babol Medical Science,Midwifery Department
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
sara.banaha20@yahoo.com
Web page address
http://www.mubabol.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sara Banaha
Street address
Ganj Afroze
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
sara.banaha20@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Grant name
Babol University of Medical Sciences
Grant code / Reference number
5086
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Sara Banaha
Position
Consultant
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Babol University of Medical Sciences , Midwifery Department
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 21 2247 3446
Fax
+98 11 3219 0181
Email
sara.banaha20@yahoo.com
Web page address
http://www.mubabol.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hajar Pasha
Position
Assistant Profosser
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ganj Afrouze
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 4327 0576
Fax
+98 11 3219 0181
Email
dhajarpasha@gmail.com
Web page address
http://www.mubabol.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sara Banaha
Position
Consultant
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ganj Afrouze
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 21 2247 3446
Fax
+98 11 3219 0181
Email
sara.banaha20@yahoo.com
Web page address
http://www.mubabol.ac.ir

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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Regarding the subject of the protocol that related to sexual matters, the more details of data is subject to the approval of the Ethics Committee of babol medical science of university
When the data will become available and for how long
Regarding the subject of the protocol that related to sexual matters, the accessibility of data is subject to the approval of the Ethics Committee of babol medical science of university
To whom data/document is available
Regarding the subject of the protocol that related to sexual matters, those who are allowed to access the data, is subject to the approval of the Ethics Committee of babol medical science of university
Under which criteria data/document could be used
Regarding the subject of the protocol that related to sexual matters,terms of use, is subject to the approval of the Ethics Committee of babol medical science of university
From where data/document is obtainable
The Ethics Committee of babol medical science of university
What processes are involved for a request to access data/document
Send letter to the Ethics Committee of babol medical science of university
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