Determining the effectiveness of acceptance and commitment therapy on sexual self-esteem and couple burnout of infertile women
Design
A single case experiment using multiple baseline design (A-B-A) that includes 4 women referring to infertility treatment centers and private gynecological offices in Tehran. Targeted sampling of the available type will be performed by repeated measurements.
Settings and conduct
Using the available purposive sampling method with repeated measurements, 4 women referring to infertility treatment centers and private gynecological offices in Tehran will be selected and Hayes Acceptance and Commitment Therapy method (2004) will be used to teach admission and commitment therapy. The number of training sessions is 8 sessions, which will be one hour and forty minutes per week.
Participants/Inclusion and exclusion criteria
Inclusion Criteria :aged 20 years to 40 years; At least four years of cohabitation (duration of infertility awareness for at least two years); Infertility due to female physical problems (ovulation disorders; uterine tube disorders; endometriosis; immune system problems) and its diagnosis and approval by a gynecologist according to her medical record at the Infertility Center; Failure to confirm false infertility (due to fertility stress) using the initial interview. Exclusion Criteria: Major psychiatric disorder and history of hospitalization and use of psychiatric drugs (according to the medical record and using interviews and confidentiality of clients).
Intervention groups
This treatment teaches people to live in the present by accepting feelings of self-control and experiential avoidance, and to better cope with the challenges ahead.
Main outcome variables
Improve flexibility and reduce negative thoughts about yourself and increase sexual self-esteem and reduce couple burnout
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210403050822N1
Registration date:2021-04-22, 1400/02/02
Registration timing:prospective
Last update:2021-04-22, 1400/02/02
Update count:0
Registration date
2021-04-22, 1400/02/02
Registrant information
Name
fateme asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6557 7990
Email address
elham.asadi7488@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Acceptance and Commitment Therapy on sexual self-esteem and couple burnout of infertile women
Public title
The effectiveness of Acceptance and Commitment Therapy on sexual self-esteem and couple burnout of infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
aged 20 years to 40 years
At least four years of cohabitation (duration of infertility awareness for at least two years)
Infertility due to female physical problems (ovulation disorders, uterine tube disorders, endometriosis, immune system problems) and its diagnosis and approval by a gynecologist according to her medical record at the Infertility Center
Failure to confirm false infertility (due to fertility stress) using the initial interview
Exclusion criteria:
Major psychiatric disorder
History of hospitalization in psychiatric department
Use of psychiatric drugs (according to the medical record and using interviews and confidentiality of clients)
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
4
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of Social Welfare and Rehabilitation Sciences
Street address
Sadaf Town, Mehdi Bayat St., North Bahman Alley, No. 48, Unit 5
City
Andishe
Province
Tehran
Postal code
3168963489
Approval date
2021-03-04, 1399/12/14
Ethics committee reference number
IR.USWR.REC.1399.247
Health conditions studied
1
Description of health condition studied
infertile women
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Sexual self-esteem of infertile women
Timepoint
Before and during the intervention and after the intervention
Method of measurement
Sexual Self-Esteem Index for Woman-Short Form (SSEI-W-SF)
2
Description
Marital boredom of infertile women
Timepoint
Before and during the intervention and after the intervention
Method of measurement
Couple burnout questionnaire (CBM) of Pines
Secondary outcomes
1
Description
Physical dimension of marital boredom
Timepoint
Before, during and after the study
Method of measurement
Pineas Marital Boredom Questionnaire
2
Description
Emotional dimension of marital boredom
Timepoint
Before, during and after the study
Method of measurement
Pineas Marital Boredom Questionnaire
3
Description
Mental dimention of marital boredom
Timepoint
Before, during and after the study
Method of measurement
Pineas Marital Boredom Questionnaire
Intervention groups
1
Description
Individual training with an approach based on acceptance and commitment, which is held in the form of 8 sessions two hours a week .Step A Baseline measurement using a questionnaire, Step B Intervention and re-measurement with a questionnaire, Step C Follow up the effects of the intervention after its completion.Acceptance and commitment therapy (ACT) has six central processes that lead to psychological flexibility. These six processes are: "acceptance, failure, self as context, present-day communication, recognizing values, and committed action." Acceptance and commitment therapy, in fact, is not intended to bring about a direct change in clients, but rather to help clients to relate to their experiences in different ways and to be able to fully live a meaningful and value-based life. (Protocol based on Hayes, Estrosal, and Wilson's book of Acceptance and Commitment). Intervention group: There are 4 infertile women who complete marital boredom with full insertion of details in the pre-test of sexual self-esteem form questionnaires before implementing the protocol. In the intervention group, the treatment protocol based on acceptance and commitment (act) will be held during 8 sessions of 2 hours. During the treatment and after that, questionnaires will be used to evaluate the changes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Leila Raiesi Women's Clinic
Full name of responsible person
Leila Raiesi
Street address
Andisheh, Phase one, 7th Street, West Golnar Dead End, No. 488, Unit 3
City
Andishe
Province
Tehran
Postal code
3168963489
Phone
+98 21 6550 6147
Email
elhamasadi7488@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Elham Asadi
Street address
Sadaf Town, Mehdi Bayat St., North Bahman Alley, No. 48, Unit 5
City
Andishe
Province
Tehran
Postal code
3168963489
Phone
+98 21 6557 7990
Email
elham.asadi7488@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Fateme Asadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Sadaf Town, Mehdi Bayat St., North Bahman Alley, No. 48, Unit 5
City
Andishe
Province
Tehran
Postal code
3168963489
Phone
+98 21 6557 7990
Email
Elham.asadi7488@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fateme asadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Sadaf Town, Mehdi Bayat St., North Bahman Alley, No. 48, Unit 5
City
Andishe
Province
Tehran
Postal code
3168963489
Phone
+98 21 6557 7990
Email
elham.asadi7488@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fateme asadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Sadaf Town, Mehdi Bayat St., North Bahman Alley, No. 48, Unit 5
City
Andishe
Province
Tehran
Postal code
3168963489
Phone
+98 21 6557 7990
Email
Elham.asadi7488@gmail.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Accurate reading of study and researcher information for reference without changing it
From where data/document is obtainable
Email addresses, telephone numbers
What processes are involved for a request to access data/document
Send a request via email and check the cause and rank of the university and receive a response