Protocol summary

Study aim
The effect of group training of sexual Assertiveness skills with cognitive-behavioral approach on sexual Assertiveness and sexual satisfaction in women with marital disillusionment is determined.
Design
Random counseling intervention is controlled by pre-test-post-test and follow-up and three-way blind.
Settings and conduct
Sampling is done in health centers of Qom and is randomized in blocks. Sexual assertiveness skills training is provided for them.
Participants/Inclusion and exclusion criteria
Iranian married 18 to 40 years, giving informed written consent, no menopause, pregnancy and lactation up to 6 months after delivery, no infertility in the woman, one year of permanent marriage, living with a spouse, being the only spouse of the husband, having at least one relationship Sex with a spouse in the past 4 weeks, no serious conflicts with the spouse, having a diploma or higher, age range, having a score of 56 or higher on the Nihois and Bartel Marital Frustration Test, a score of 50 or lower on the Halbert Worst Index, no The use of psychedelics, anti-anxiety and anti-stress drugs and drugs that interfere with sexual function, the absence of the use of drugs and surgeries on sexual function, the absence of alcohol and drugs in the couple, is not. Disorder of consciousness, no history of hospitalization in the psychiatric ward, no incurable disease such as cancer, not attending counseling courses similar to the current intervention, no tragic accident in the previous 6 months (death).
Intervention groups
Sexual Assertiveness skills with a cognitive-behavioral approach based on Aaron Beck's theoretical framework and Ratus assertiveness program in groups of 8-10 people are taught by the researcher in the form of 8 sessions 90-minute per week. A mock intervention is also performed for the control group by the researcher.
Main outcome variables
Sexual assertiveness - sexual satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220302054162N1
Registration date: 2022-03-31, 1401/01/11
Registration timing: registered_while_recruiting

Last update: 2022-03-31, 1401/01/11
Update count: 0
Registration date
2022-03-31, 1401/01/11
Registrant information
Name
Faezeh Saffari Mofrad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3777 8938
Email address
f.saffari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-09, 1400/11/20
Expected recruitment end date
2022-04-09, 1401/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of group training on sexual assertiveness and sexual satisfaction in women with marital disillusionment
Public title
The impact of group training on sexual assertiveness and sexual satisfaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality, giving informed written consent No menopause, no pregnancy and lactation up to 6 months after delivery, no infertility in women Marriage, at least one year of permanent marriage, absence from the spouse for any reason during the intervention and follow-up period (living with the spouse), the person is the only spouse of the husband, having at least one sexual intercourse with the spouse for the past 4 weeks , No serious conflicts with the spouse, not on the verge of divorce Having a diploma or higher A score of 56 or higher on the Nihois & Bartell Marital Disillusionment Scale (MDS), a score of 50 or lower on Hulbert Index of Sexual Assertiveness (HISA) No use of psychedelic, anti-anxiety and anti-depressant drugs and drugs that interfere with sexual function, no disease and surgeries affecting sexual function, no alcohol and substance abuse in the couple, no consciousness disorder, no history Hospitalization in the psychiatric ward, not having incurable diseases such as cancer Failure to participate in counseling courses with the same content as the present intervention, no occurrence of an unfortunate accident in the previous 6 months (dear death). Age range 18-40 years
Exclusion criteria:
Pregnancy during research getting a divorce and the occurrence of severe marital conflicts developing incurable diseases during the study not participating in two intervention sessions.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be block type. 20 blocks with a volume of 4 are used. In each block, two allocations for the control group and two allocations for the intervention group are considered. Random sequencing will be generated by web-based randomization using the site (https://www.sealedenvelope.com). The generated sequence will also be centrally hidden so that the list of random assignment sequences is provided to someone outside the research team. As soon as a person is eligible to participate in the study, the researcher or sampler will contact the person who has the random assignment sequence and he or she will code the participants to enter the study according to the sequence list.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a three-blind study because the participants are unaware of the type of intervention because the control group also has a fake intervention. The questionnaires will be completed in the post-test and follow-up phase by questioners who do not know how the participants are placed in the intervention and control groups, and the statistical expert who will analyze the data will also know the codes of the participants in the intervention and control groups. Does not know.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Shahid Shiroodi St., Alam al-Huda St.
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2022-01-02, 1400/10/12
Ethics committee reference number
IR.ARAKMU.REC.1400.285

Health conditions studied

1

Description of health condition studied
Women's marital disillusionment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual assertiveness (theoretical definition): A branch of sexual communication and a social skill that includes displaying assertive behavior in sexual situations and includes various components such as the ability to initiate desirable sexual activity and express their sexual needs, refusal to Unwanted sexual contact and discussion of the use of contraceptive methods to prevent unwanted pregnancies and sexually transmitted diseases.(Practical definition): The score that a subject receives from the Halbert Sexual Assertiveness Index. A score of 50 or less indicates low audacity.
Timepoint
Before the intervention, end of the eighth session and three months after the intervention.
Method of measurement
the Halbert Sexual Assertiveness Index.

Secondary outcomes

1

Description
Sexual Satisfaction: (theoretical definition): An emotional response resulting from the evaluation of a person's sexuality and includes meeting the sexual needs of the person, fulfilling the expectations of the person and his sexual partner and a positive evaluation of the person throughout the sexual relationship. (Practical definition): is the score that the subject receives from the Women's Sexual Satisfaction Scale (SSS-W). A higher score means higher sexual satisfaction.
Timepoint
Before the intervention (beginning of the first intervention session), end of the eighth session and three months after the intervention
Method of measurement
Women's Sexual Satisfaction Scale (SSS-W)

Intervention groups

1

Description
Intervention group: Sexual Assertiveness skills with a cognitive-behavioral approach based on Aaron Beck theoretical framework and Ratus assertiveness program are taught in groups of 8-10 people by the researcher (student). The training is in the form of 8 90-minute weekly sessions that will be held on even days in health centers.
Category
Lifestyle

2

Description
Control group: Common diseases of women will be taught weekly in eight 90-minute sessions per day in health centers.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemi Health Center
Full name of responsible person
Faezeh Saffari Mofrad
Street address
No. 66, Mohtasham Kashani Blvd., next to Shabnam Park
City
QOM
Province
Ghoum
Postal code
3719155719
Phone
+98 912 747 3822
Email
f.mofrad1984@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Street address
Shahid Shiroodi St., Alam al-Huda St.
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3417 3502
Email
info@arakmu.ac.ir
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
60
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
Faezeh Saffari Mofrad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No66, Mohtasham Kashani Blvd,
City
Qom
Province
Ghoum
Postal code
3719155719
Phone
+98 25 3777 8938
Fax
Email
f.saffari@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Faezeh Saffari Mofrad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No66, Mohtasham Kashani Blvd,
City
Qom
Province
Ghoum
Postal code
3719155719
Phone
+98 25 3777 8938
Fax
Email
f.saffari@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Faezeh Saffari Mofrad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No66, Mohtasham Kashani Blvd,
City
Qom
Province
Ghoum
Postal code
3719155719
Phone
+98 25 3777 8938
Fax
Email
f.saffari@arakmu.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
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