The effectiveness of treatment on compassion in reducing emotional repression and Perception of the suffering of women with vitiligo undergoing phototherapy.
Investigating the effect of treatment on compassion on emotional suppression and perception of suffering in vitiligo patients.
Design
In order to assign people to two experimental groups, the block randomization method is considered by considering blocks 4, 6 and 8. To generate a sequence of random numbers, the software on the web at https://www.sealedenvelope.com/simple-randomiser/v1/lists was used.
The sample size is 40 patients with vitiligo
The clinical trial has a control group.
Settings and conduct
The place where the intervention will be performed is in Razi Skin Superspeciality Hospital in Tehran, it will be done in person and virtually
The treatment method is group therapy (focused therapy).
Participants/Inclusion and exclusion criteria
Entry criteria: 1. Not taking psychiatric drugs. 2. No disease except vitiligo. 3. Not suffering from acute mental illness. 4. female gender 5. Vitiligo diagnosis by the attending physician. 6. Age range between 18 and 40 years. 7. Minimum education of diploma. 8. When receiving this treatment, the client should not receive any other psychological treatment and must have completed the previous psychological treatments one month before entering the treatment. 9. Informed consent to participate in research.
Output criteria: 1. Absence of more than two sessions. 2. Non-cooperation 3. It should be determined that the patient has a mental disorder or is taking psychiatric medication.
Intervention groups
The intervention group consists of 20 women with vitiligo undergoing undergoing phototherapy., which is a treatment on compassion twice a week.
The control group includes 20 women with vitiligo undergoing phototherapy. who will not receive any psychological and psychiatric treatment.
Main outcome variables
Reducing emotional suppression in vitiligo patients؛ reducing the perception of suffering in vitiligo patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220403054398N1
Registration date:2022-10-30, 1401/08/08
Registration timing:prospective
Last update:2022-10-30, 1401/08/08
Update count:0
Registration date
2022-10-30, 1401/08/08
Registrant information
Name
Saeid Einali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5575 2660
Email address
saeideinali.psy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-02-08, 1401/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of treatment on compassion in reducing emotional repression and Perception of the suffering of women with vitiligo undergoing phototherapy.
Public title
The effect of compassion therapy on emotional repression and perception of suffering of female patients with vitiligo.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Vitiligo diagnosis by the attending physician is a condition for entering the study.
The age range between 18 and 40 years is the condition for entering the study.
Female gender is a condition for entering the study.
Exclusion criteria:
The use of psychiatric drugs is not included in the study.
Co-occurring with vitiligo is a reason not to enter the study.
Suffering from psychiatric diseases is the reason for not entering the study.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign individuals to two experimental groups, the block randomization method was considered by considering blocks 4, 6 and 8. To generate a sequence of random numbers, the web-based software at https://www.sealedenvelope.com/simple-randomiser/v1/lists has been used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The sample population was divided into two experimental and control groups, and in one group, the intervention (compassion therapy) was implemented, and in the intervention control group, the intervention could not be done, after that, the specified questionnaires were tested in the pre-test and post-test And follow up and analyze, compare and draw conclusions.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Medical School-Tehran University of Medical Sciences
Street address
No.12, Vahdat Eslami Ave.
City
Tehran
Province
Tehran
Postal code
1199663911
Approval date
2022-08-30, 1401/06/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.414
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
2
Description of health condition studied
Perception of Suffering
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Emotional Repression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The score of the Weinberger Adaptability Questionnaire (WAI) .
Timepoint
Before the start of the intervention, after the end of the intervention, one month after the end of the intervention.
Method of measurement
Weinberger Adaptability Questionnaire (WAI).
2
Description
The score of the Scholz Suffering Questionnaire.
Timepoint
Before the start of the intervention, after the end of the intervention, one month after the end of the intervention.
Method of measurement
Scholz Suffering Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group of compassion-focused therapy had 8 sessions as two 90-minute sessions in four consecutive weeks, which used techniques (such as: meditation and recognition of emotions and cognitive errors). . Description of Compassion-Focused Therapy (CFT) Sessions The first session: establishing initial communication, grouping, overview of the structure of the sessions, getting to know the general principles of CFT therapy and distinguishing compassion from self-pity; Evaluating the amount of emotional abuse, describing and explaining emotional abuse and factors related to its symptoms and conceptualizing self-compassion training. Second session: Mindfulness training along with physical examination and breathing exercises, familiarity with brain systems based on compassion, empathy training; Teaching to understand how people feel to follow things with an empathic attitude and homework. The third session: getting to know the characteristics of people with compassion, compassion towards others, cultivating a feeling of warmth and kindness towards oneself, cultivating and understanding that others also have defects and problems (cultivating a sense of human commonality) in front of self-destructive feelings and shame, training Sympathy; and providing homework. The fourth session: reviewing the exercise of the previous session, encouraging the subjects to self-identify and examine their personality as a "compassionate" or "non-compassionate" person according to educational topics, identification and application of "compassionate mind training" exercises (the value of self-compassion, empathy and Compassion towards oneself and others, (physiotherapist metaphor training), forgiveness training and homework. Fifth session: review of the exercise of the previous session, familiarity and application of "compassionate mind exercises" (forgiveness, non-judgmental acceptance and tolerance training), training to accept problems. Accepting upcoming changes and enduring difficult and challenging conditions due to the variability of the life process. The sixth session: review of the exercise of the previous session, practical exercise of creating compassionate images, teaching the styles and methods of expressing compassion (verbal compassion, practical compassion, cross-sectional compassion and continuous compassion) and applying these methods in daily life and for parents, friends, Teachers and acquaintances, teaching the development of valuable and sublime feelings and homework. . Seventh session: Reviewing the practice of the previous session, teaching how to write compassionate letters for yourself and others, teaching the method of "recording and keeping a diary of real situations based on compassion and the person's performance in that situation". The eighth session:training and practicing skills; Reviewing and practicing the skills presented in the previous sessions to help the subjects to deal with the different conditions of their lives in different ways and finally summarizing and providing solutions to maintain and apply this treatment method in everyday life.
Category
Behavior
2
Description
Control group: does not receive any treatment.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Zainab Aryanian
Street address
No.12, Vahdat Eslami Ave
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
razihospital@sina.tums.ac.ir
Web page address
http://razihos.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zainab Aryanian.
Street address
Vahdat Islami Ave
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
z-aryanian@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
90
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
2
Sponsor
Name of organization / entity
Shahab Danesh University.
Full name of responsible person
Azam bayanlou.
Street address
Pardisan.Shahab Danesh University.
City
Qom
Province
Ghoum
Postal code
3711687764
Phone
+98 912 040 8713
Email
a.bayanlou@yahoo.com
Web page address
https://shdu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahab Danesh University.
Proportion provided by this source
10
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
Tehran University of Medical Sciences
Full name of responsible person
Zainab Aryanian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vahdat Islami
City
Tehran
Province
Tehran
Postal code
۱۱۹۹۶۶۳۹۱۱
Phone
+98 21 5563 0553
Email
z_aryanian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zainab Aryanian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vahdat Islami
City
Tehran
Province
Tehran
Postal code
۱۱۹۹۶۶۳۹۱۱
Phone
+98 21 5563 0553
Email
z_aryanian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zainab Aryanian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No.12,Vahdat Islami Ave
City
Tehran
Province
Tehran
Postal code
۱۱۹۹۶۶۳۹۱۱
Phone
00962155630553
Email
z_aryanian@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
Undecided - It is not yet known if there will be 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
The result of the article will be available in full.
When the data will become available and for how long
Taking into account the execution time and the requirements of printing the article, it is expected that 2023 data will be available.
To whom data/document is available
Access will be possible for the general researchers.
Under which criteria data/document could be used
Conducting further research.
From where data/document is obtainable
Request from authors
Dr. Zainab Arianian
z_aryanian@yahoo.com
Dr. Azam Bayanlou
a.bayanlou@yahoo.com
Saeid Einali
saeideinali.psy@gmail.com
What processes are involved for a request to access data/document
Requests for data will be sent to researchers and will be sent within two weeks if possible.