Protocol summary

Study aim
Determining the effect of self-compassion training on body image, self-esteem, and cognitive emotion regulation in women referring to beauty clinics
Design
A clinical trial with a control group, with parallel groups, without blinding, with a sample size of 40 people, which will be assigned into two intervention and control groups by random block design.
Settings and conduct
Sampling will be done in selected beauty clinics in Dezful city. The training sessions will be held as 8 sessions of 90 minutes as a group and once a week in a counseling center in Dezful city.
Participants/Inclusion and exclusion criteria
Women referring to beauty clinics will comprise the samples of this research. inclusion criteria will include the age above 18 years, non-referral due to medical problems, ability to understand and speak Persian, and Being literate in reading and writing. Exclusion criteria also will include severe illness or injury, being under other psychological treatment, suffering from severe psychiatric disorders, and having a drug addiction or abuse.
Intervention groups
Self-compassion training will be done in the intervention group. This program will be in the form of training and group discussion for 8 sessions of 90 minutes, which will be implemented weekly. Sessions will cover the basics of self-compassion, introducing the characteristics and skills of self-compassion and how it affects mental states, mental imagery, cultivating self-compassion and introducing the concepts of wisdom, ability, intimacy and responsibility, writing a letter of compassion and fear, and the fear of self-compassion and identifying thoughts hindering the cultivation of self-compassion. No intervention will be done in the control group.
Main outcome variables
body image, self-esteem, and cognitive emotion regulation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230901059318N1
Registration date: 2023-10-05, 1402/07/13
Registration timing: registered_while_recruiting

Last update: 2023-10-05, 1402/07/13
Update count: 0
Registration date
2023-10-05, 1402/07/13
Registrant information
Name
Kobra Cheraghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4253 0940
Email address
k.cheraghi11@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2023-11-11, 1402/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-compassion training on body image, self-esteem, and cognitive emotion regulation in women referring to beauty clinics
Public title
The effect of self-compassion training on psychological components in women referring to beauty clinics
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years Non-referral due to medical problems Ability to understand and speak Persian Being literate in reading and writing
Exclusion criteria:
Severe illness or injury Being under other psychological treatment Suffering from severe psychiatric disorders Having a drug addiction or abuse
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
A quadruple random block design will be used to randomly assign the samples to two control and intervention groups. Code A will be assigned to the intervention group and code B will be assigned to the control group. Then the website: https://www.sealedenvelope.com will be used to determine the required random blocks and their sequence. In addition, sealed envelopes will be used to maintain concealment. Accordingly, based on the sequence of random blocks, cards with the letters A (for the intervention group) or B (for the control group) demonstrating the assignment sequence will be put inside the envelope. An envelope will then be opened for each participant in the study, respectively, and will be assigned to the study's groups based on the card inside the envelope.
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 Islamic Azad University, Ahvaz branch
Street address
Azad University, Farhangshahr Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6155954394
Approval date
2023-09-05, 1402/06/14
Ethics committee reference number
IR.IAU.AHVAZ.REC.1402.135

Health conditions studied

1

Description of health condition studied
training self-compassion and the psychological state of women visiting beauty clinics
ICD-10 code
ICD-10 code description
psychological

Primary outcomes

1

Description
Body image: It is the score obtained from the answers to the body image questionnaire of Cash and Pruzinsky (1983).
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the intervention
Method of measurement
Cash and Pruzinsky body image questionnaire

2

Description
Self-esteem: It is the score obtained from the answer to Rosenberg's self-esteem questionnaire.
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the intervention
Method of measurement
Rosenberg's self-esteem questionnaire

3

Description
Cognitive regulation of emotion: it is the score obtained from the response to the questionnaire on cognitive regulation of emotion Garnefski and Kraaij (2006).
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the intervention
Method of measurement
Garnefski and Kraaij's cognitive regulation of emotion questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Self-compassion training will be done in the intervention group. This program will be in the form of training and group discussion for 8 sessions of 90 minutes, which will be implemented weekly. Sessions will cover the basics of self-compassion, introducing the characteristics and skills of self-compassion and how it affects mental states, mental imagery, cultivating self-compassion and introducing the concepts of wisdom, ability, intimacy and responsibility, writing a letter of compassion and fear, and the fear of self-compassion and identifying thoughts hindering the cultivation of self-compassion.
Category
Behavior

2

Description
Control group: No intervention will be done in the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ara Dermatology Clinic
Full name of responsible person
Saeed tavakoli neghad
Street address
Second floor, Imam Ali Clinic, Roosta Street
City
Dezfoul
Province
Khouzestan
Postal code
6461851105
Phone
+98 61 4227 0634
Email
dr_saeedtn@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam gholamzade jefre
Street address
Azad University, Farhanshahr Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8420
Email
Gholamzadeh.m723@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Maryam gholamzade jefre
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Azad University, Farhangshahr Blvd
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹۳۷۳۳۳
Phone
+98 916 111 9965
Email
Gholamzadeh.m723@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kobra Cheraghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 416, North Hazrat Rasool Ave., Andishe Precinct
City
Dezful
Province
Khouzestan
Postal code
۶۱۳۴۹۳۷۳۳۳
Phone
+98 61 4253 0940
Fax
Email
K.cheraghi11@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kobra Cheraghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 416, North Hazrat Rasool Ave., Andishe Precinct
City
Dezful
Province
Khouzestan
Postal code
۶۱۳۴۹۳۷۳۳۳
Phone
+98 61 4253 0940
Fax
Email
K.cheraghi11@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The information about the pre-test and post-test of the participants will be published after the end of the study.
When the data will become available and for how long
The data access period begins after the results are published.
To whom data/document is available
Researchers
Under which criteria data/document could be used
Researchers who need data to conduct research under common scientific and humanitarian ethical standards can submit their request by email.
From where data/document is obtainable
You should send your request to these two emails: fv.foroughi@gmail.com and Gholamzadeh.m723@gmail.com
What processes are involved for a request to access data/document
The researcher sends her request in writing to the mentioned two emails. Then, request will be reviewed and if approved, the data will be sent.
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