Protocol summary

Study aim
Developing a quantitative model of psychological correlates of sexual desire/arousal disorder and comparing the effectiveness based on it with activation-behavioral therapy on sexual self-concept, menopausal attitude, sexual dysfunctional beliefs, relationship satisfaction and relational intimacy of postmenopausal women.
Design
Clinical trial with control group, with parallel groups, single blind, randomized, on 45 postmenopausal women with sexual desire/arousal disorder. Excel software is used for randomization. ​
Settings and conduct
The method of conducting the present research will be quantitative and semi-experimental, and before entering each of the steps and starting the research, the necessary permits for the implementation of the research, such as the letter of introduction to sexual counseling and psychotherapy centers and the code of ethics, will be obtained and after the approval of the authorities Medical centers will collect data
Participants/Inclusion and exclusion criteria
Postmenopausal women with sexual desire/arousal disorders over 50 years old, who have been 6 months since their menopause, who do not take any drugs or medical interventions or do not miss more than two sessions during the session, and do not have premature menopause.
Intervention groups
The participants will be randomly assigned to two experimental groups and one control group, and behavioral activation therapy package (8 sessions of 90 minutes), therapy package based on the quantitative model of psychological correlates of sexual desire/arousal disorder (8 sessions of 90 minutes) for Treatment groups will be implemented. ​
Main outcome variables
Sexual self-concept, menopause attitude, dysfunctional sexual beliefs, elationship satisfaction and relational intimacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230524058276N1
Registration date: 2023-12-10, 1402/09/19
Registration timing: prospective

Last update: 2023-12-10, 1402/09/19
Update count: 0
Registration date
2023-12-10, 1402/09/19
Registrant information
Name
somayeh heidary shadehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4526 6041
Email address
sm85.heidary@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Develop a quantitative psychological correlates of sexual arousal / arousal disorders correlations and compare the effectiveness of intervention based on it with behavioral activation therapy on sexual self-concept, menopausal attitude, sexual dysfunction, relationship satisfaction and communication intimacy of postmenopausal women
Public title
The effectiveness of the intervention based on the quantitative model of psychological correlates of sexual desire/arousal disorder and activation-behavioral therapy on sexual self-concept, menopausal attitude, sexual dysfunctional beliefs, relationship satisfaction and relational intimacy of postmenopausal women.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal women whose menopause has been 6 months old Being over 50 years old Having a sexual desire/arousal disorder Not taking drugs and drug interventions Not receiving treatment interventions at the same time
Exclusion criteria:
Having at least 2 absent sessions in the intervention process Having other sexual dysfunctions other than sexual desire/arousal Having early menopause
Age
From 50 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The purpose of random allocation is that the clinician cannot predict the treatment of the disease. Random allocation of the type of treatment or random allocation is the heart of the clinical trial study. The samples will be determined by random block method and using random number table, Random Allocation Software. Blocking and allocation sequence will be done for concealment by a person not involved in the research (Allocation Concealment). Blocking: This method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization ensures that there is no significant imbalance between groups at any time during randomization. At certain points, the number of participants in each group is equal. For this method, the size of each block must be determined first (for example, a block of four), then write the list of blocks and assign numbers to them (AABB(1)-ABAB(2)-ABBA(3)-BBAA(4)-BABA) (5) - BAAB (6)), then choosing random numbers between 1 and 6 (for example 1, 4, 5 and ...) and finally specifying the treatment allocation list based on the previous random numbers (...AABB-BBAA-BABA-) They will be placed in three groups including two intervention groups and one control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants, or in other words, the people who are invited to participate in the study and are classified into intervention groups after obtaining informed consent, may not know the main purpose of the study, these people only know that in a study They participate, which will lead to the improvement of their psychological problems, and they are only unaware of the assignment of groups. Statistical analysts do not know the content of therapy sessions, but they know the assumptions, goals and questions of the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan Islamic Azad University (Khorasgan).
Street address
Unit 18- Ramin Complex- 1st sub-section- 8 East sub-section- Taleghani Blvd.
City
Shahinshahr
Province
Isfehan
Postal code
8347113574
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.IAU.KHUISF.REC.1401.408

Health conditions studied

1

Description of health condition studied
Sexual desire/arousal disorder
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder

Primary outcomes

1

Description
Sexual self-concept is a part of individuality and self-sexuality; In other words, a person's understanding of his sexual desires and tendencies is the same as his sexual self-concept
Timepoint
At the beginning of the study, after the intervention and 45 days after the intervention
Method of measurement
Sexual self-concept in this research is the score that the subjects get from Ansel's (2013) sexual self-concept questionnaire. This questionnaire contains 78 questions and 18 subscales. The range of scores in each subscale is 5 to 25. Scores higher than the average in each subscale indicate that the individual has more of that characteristic (tendency). If the scores of the questionnaire are between 1 and 20, the variable rate in this society is weak. If the scores of the questionnaire are between 21 and 60, the variable amount is at an average level. If the scores are above 60, the level of the variable is high.

2

Description
Attitude is a set of beliefs, emotions and behavioral intentions towards an object, person or event. In other words, it is a relatively stable desire for a person, something or an event that manifests itself in feelings and behavior
Timepoint
At the beginning of the study, after the intervention and 45 days after the intervention
Method of measurement
Menopause attitude in this research is the score that the subjects got from Neugarten's attitude towards menopause questionnaire (1963). This questionnaire contains 35 items, in this questionnaire, each item is given a score with a 5-point range from 0 to 4, and the total score is added after counting all the items, and higher scores are given to positive attitudes and grades. lower was attributed to negative attitude. The cut-off point is considered to be 40, and a score of 40 and above is considered a positive attitude, and a score below that is considered a negative attitude.

3

Description
Sexual dysfunctional belief is a set of attitudes and stereotypes about sexual performance that endangers the sexual relationship of couples.​
Timepoint
At the beginning of the study, after the intervention and 45 days after the intervention
Method of measurement
In this research, the meaning of sexual dysfunctional belief is the scores that will be obtained in response to the questionnaire of Neuber, Pinto and Govia (2003). In this questionnaire, scoring is done in a direct way and a higher score indicates a greater impact of sexual dysfunctional beliefs on sexual performance. It is women and men.

4

Description
Relationship satisfaction is defined as the level of satisfaction that a person has in his closest adult relationship with another person in different dimensions. This level includes communication and honesty, intimacy and closeness, resolving conflicts and arguments, satisfaction with his role in the relationship and Satisfaction with another's role in the relationship and overall satisfaction with the relationship
Timepoint
At the beginning of the study, after the intervention and 45 days after the intervention
Method of measurement
The meaning of relationship satisfaction is the score that each subject obtained in the 7-item relationship satisfaction scale of Burns and Cyrus (1988). The scores of the groups of this questionnaire range from 0-10 indicating a very dissatisfied person, 20-11 indicating a dissatisfied person, 21-25 indicating a relatively dissatisfied person, and 30-26 indicating a somewhat dissatisfied person, 31-35 indicating a somewhat satisfied person. 36-40 indicates relatively satisfied and 41-42 indicates a very satisfied person.​

5

Description
ommunication intimacy is the need to communicate and share all emotions, including positive emotions (joy, ecstasy, and excitement) and negative emotions (sadness, failure, fear, guilt, loneliness, and depression) with the spouse.
Timepoint
At the beginning of the study, after the intervention and 45 days after the intervention
Method of measurement
Communication intimacy means the score that each subject obtained in Shafer and Olson's (1981) 36-question communication intimacy scale. The overall score of this questionnaire is between 1 and 120. The amount of difference between two scores of received intimacy and expected intimacy indicates the level of satisfaction of the person with intimacy.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Behavioral activation therapy is also treated during 8 sessions of 90 minutes based on the training package of Dimidjin et al. (2008). It is taught simply. The second session of behavioral activation is taught by focusing on the interaction between the person and the environment based on the principles of silence, shaping, elimination and mental review, distance distraction, procedural skills and observational thinking. Providing homework, review and feedback. The third session of healing processes is taught with four topics of advice in the general context of the disease, choosing the appropriate treatment method for the individual's condition, motivational topics and the interaction of the individual with other people and the use of their experience, providing homework, review and feedback. The fourth session is review of the form. The use of verbal positive reinforcement is taught through the expression of positive and hopeful sentences, the presentation of homework, review and feedback. The fifth session of using metaphor is taught in the course of verbal positive reinforcement, the presentation of homework, review and feedback. The sixth session of cognitive reconstruction, Psychosocial aspects of the problem, coping skills, assertiveness skills and treatment in case of recurrence, referral to a psychologist is taught, assignments are given, feedback is taught. In the seventh session, problem solving skills are taught, which includes defining the problem, identifying the factors preventing problem solving, and the problem solving process. , commiting to implement the solution, planning to implement the best solution and implementing the best solution, providing homework, feedback. The eighth session of summarizing, summarizing, and teaching preventive solutions
Category
Lifestyle

2

Description
Intervention group: ntervention group: treatment package based on the quantitative model of psychological correlates of sexual desire/arousal disorder (Heidari, Sajjadian and Manshai, 1402). Eight 90-minute intervention sessions​
Category
Lifestyle

3

Description
Control group: a group that does not undergo any intervention. They only complete the questionnaires before and after the study. If they wish, they can undergo intervention after the end of the study.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Andisheh Counseling Center
Full name of responsible person
Ali Sharifi
Street address
Unit 3 - 2nd floor - Asia Insurance Building 18 - Next to Sepahan Passage - Elkhebal Square
City
Isfahan
Province
Isfehan
Postal code
8347113574
Phone
+98 31 4524 5505
Email
alisharifi.andishe@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Zamani Borojni
Street address
University Blvd.- Arghwanieh- East J St
City
Isfahan
Province
Isfehan
Postal code
3999881551
Phone
+98 31 3535 4001
Email
info@khuisf
Web page address
http://newkhuisif.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
(دانشگاه ازاد اسلامی واحد اصفهان (خوراسگان
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Somayeh Heidary Shadehi
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Unit 18- Ramin Complex- 1st sub-section- 8 East sub-section- Taleghani Blvd.
City
Shahinshar
Province
Isfehan
Postal code
8347113574
Phone
+98 31 4529 4738
Email
sm85.heidary@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Heidary Shadehi
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Unit 18- Ramin Complex- 1st sub-section- 8 East sub-section- Taleghani Blvd.
City
Shahinshahr
Province
Isfehan
Postal code
8347113574
Phone
+98 31 4529 4738
Email
sm85.heidary@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Heidary Shadehi
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Unit 18- Ramin Complex- 1st sub-section- 8 East sub-section- Taleghani Blvd.
City
Shahinshahr
Province
Isfehan
Postal code
8347113574
Phone
+98 31 4529 4738
Email
sm85.heidary@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data file of the participants only in general and without mentioning the name and address of the participants (number-gender-age-education). The study protocol can also be published as a table. The statistical analysis map can be published in the form of tables and statistical results obtained. Informed consent can be published in its entirety. Applied research results can be published. Statistical methods and statistical analysis can be published. The obtained data can be published in the form of tables. All the above items can be provided in accordance with the guidelines of the magazines and if there is no harm to the participants.
When the data will become available and for how long
The access period starts with the opinion and agreement of the relevant journals
To whom data/document is available
It will be accessible to all people who have access to reliable sources of publishing articles such as reliable magazines and the results of this research can be used for them.
Under which criteria data/document could be used
All cases of using the documents will be possible with the permission of the university of the place of study and professors related to the research and in compliance with the existing rules and regulations.
From where data/document is obtainable
Reputable journals in which articles related to research are published. The e-mails of the advisors and advisors and the student implementing the project and their university website will be made available to the applicants to use the results in compliance with the rules and regulations and maintaining the confidentiality of the participants.
What processes are involved for a request to access data/document
If the laws related to the research documents are followed, the possible requests will be answered as soon as possible.
Comments
All of the above can be done within the framework of the rules and regulations of research and publication in the relevant journals and universities. If an item is not within the scope of these rules, it will not be published. The special case to be mentioned is maintaining the confidentiality of the participants' information and not harming them. ​
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