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Investigating the effect of self-compassion training on the sexual self-concept of infertile women referring to the infertility center.

Protocol summary

Study aim
Determining the effect of self-compassion training on the sexual self-concept of infertile women referring to the infertility center of Sayad Shirazi Hospital in Gorgan 2024.
Design
Clinical trial with two control and intervention groups, without blinding, randomized, phase 3 on 64 infertiles. Quadruple block method will be used for randomization.
Settings and conduct
64 infertile women referring to Nahal center of Sayad Shirazi educational and therapeutic center in Gorgan will be selected by available sampling method, these people will complete the tools used in this research in a self-reported manner and online and in person before and after the intervention. . These people will be placed in two groups, intervention and control, in the form of blocks of four. The women of the intervention group are invited to participate in the self-compassion group training program online, including 8 weekly sessions of 60 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria (Iranian nationality, having a minimum secondary education or higher, infertility due to female causes, access to a smartphone, access to the Internet, couples being the only spouses of each other)؛ Exclusion criteria (any mental disorder, education degree in related fields, History of participation in similar psychological interventions, the occurrence of an unfortunate event in the last three months)
Intervention groups
The intervention group will receive self-compassion training based on Gilbert's theory, the control group will not receive any training during the intervention.
Main outcome variables
Increasing the positive dimension and decreasing the negative dimension of sexual self-concept, improving compassion for self and others, improving mental health and quality of life of infertile women.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240529061943N1
Registration date: 2024-06-29, 1403/04/09
Registration timing: prospective

Last update: 2024-06-29, 1403/04/09
Update count: 0
Registration date
2024-06-29, 1403/04/09
Registrant information
Name
mohadeseh eskandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3521 2554
Email address
mohadeseesk78@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-23, 1403/05/02
Expected recruitment end date
2025-07-24, 1404/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of self-compassion training on the sexual self-concept of infertile women referring to the infertility center.
Public title
Investigating the effect of self-compassion training on the sexual self-concept of infertile women.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality Having at least a high school education Infertility due to female causes Smartphone access Internet access The couple should be each other's only spouse
Exclusion criteria:
Any mental disorder that has been confirmed by a psychiatrist or taking psychiatric medication for it (self-report) Degree in medical sciences, psychology and counseling Experience of participating in psychological interventions based on self-compassion and mindfulness The occurrence of an unfortunate incident in the last three months
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
The people participating in the study will be assigned to two intervention (A) and control (B) groups using Block Randomization. In this way, using a dice that has 6 faces, the samples are assigned to their groups. A number is written on each face, and each number is assigned to one of the blocks in the table, which shows its own state. Group A (online self-compassion training) and B (not receiving self-compassion training).
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 Golestan University of Medical Sciences
Street address
Central Organization of Golestan University of Medical Sciences and Healthcare Services, Hirkan Blvd
City
Gorgan
Province
Golestan
Postal code
4915810016
Approval date
2024-06-18, 1403/03/29
Ethics committee reference number
IR.GOUMS.REC.1403.116

Health conditions studied

1

Description of health condition studied
Sexual self-concept،Self-compassion.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual self-concept
Timepoint
Measurement of sexual self-concept at the beginning of the intervention (before the start of the intervention) and after the end of the intervention
Method of measurement
Snell's multifaceted sexual self-concept questionnaire

Secondary outcomes

1

Description
Self-compassion.
Timepoint
Measuring self-compassion at the beginning of the intervention (before the intervention) and after the end of the intervention.
Method of measurement
12-item self-compassion short scale Raes et al.

Intervention groups

1

Description
Intervention group: In these people, after the formation of training groups, the online training program will be held in groups of 8 sessions of 60 minutes, during one session per week consecutively and with prior coordination in 3 groups of 8 to 12 people. Before the start of the session, the researcher will send the assignments in the Skyroom group and in this way, before the training session, the assignments completed in the previous session will be collected. has done) will be held under the supervision of an expert advisor (doctorate in psychology).
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nahal Infertility Center, Sayad Shirazi Hospital, Gorgan
Full name of responsible person
Asieh Sadat Baniaghil
Street address
Sayad shirazi BLVD
City
Gorgan
Province
Golestan
Postal code
4915810016
Phone
+98 905 742 9931
Email
mohadeseesk78@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narges Beigom Mirbehbahani
Street address
Central Organization of Golestan University of Medical Sciences and Healthcare Services, Hirkan Blvd
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0310
Email
Info@goums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Asieh Sadat Baniaghil
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Central Organization of Golestan University of Medical Sciences and Healthcare Services, Hirkan Blvd
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0310
Email
a_baniaghil@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Asieh Sadat Baniaghil
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Central Organization of Golestan University of Medical Sciences and Healthcare Services, Hirkan Blvd
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0310
Email
a_baniaghil@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Asieh Sadat Baniaghil
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Central Organization of Golestan University of Medical Sciences and Healthcare Services, Hirkan Blvd
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0310
Email
a_baniaghil@yahoo.com

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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