Protocol summary

Study aim
Determining the effect of counseling based on positive psychology on the body image of burn patients
Design
30 members of the selected study group will be given 6 sessions of counseling based on positive psychology for 3 weeks, two one-hour sessions per week. The control group, with parallel groups, before the intervention. At the end of the intervention, the multidimensional body-self relations questionnaire is completed.
Settings and conduct
This study will be performed in the burn unit of Imam Khomeini Hospital at Kermanshah, and counseling based on positive psychology to 30 selected patients per day for them who It is determined to be presented within 3 weeks. Before the intervention and at the end of the intervention, the questionnaire of multidimensional body-self relations is completed.
Participants/Inclusion and exclusion criteria
Entry requirements: Grade 2 and higher burns No mental problems and mental disorders Being 18 to 50 years old Acceptable listening and speaking ability Requires follow-up for at least a month or more Interest in cooperation No drug addiction and sedatives No entry: Grade 1 burns Drug addiction and sedatives Having mental problems and mental disorder Age less than 18 years The duration of follow-up treatment is less than one month
Intervention groups
To the intervention group, in addition to the usual treatment, counseling based on positive psychology on the body image of burn patients during 3 weeks, which is provided twice a week for one hour, educational content (hope, happiness, gratitude, etc.), but The control group receives only routine medical services and does not receive any intervention.
Main outcome variables
Body image

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210308050629N1
Registration date: 2021-04-29, 1400/02/09
Registration timing: prospective

Last update: 2021-04-29, 1400/02/09
Update count: 0
Registration date
2021-04-29, 1400/02/09
Registrant information
Name
Zahra Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 1726 8030
Email address
zahra59.moradi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based positive psychology on the body image of burn patient
Public title
Investigating the effect of counseling based on positive psychology on body image
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Grade 2 and higher burns No mental problems and mental disorders Being 18 to 50 years old Acceptable listening and speaking ability Requires follow-up for at least a month or more Interest in cooperation No drug addiction and sedatives
Exclusion criteria:
Grade 1 burns Drug addiction and sedatives Having mental problems and mental disorder Age less than 18 years The duration of follow-up treatment is less than one month
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible samples, after obtaining informed consent, will be randomly assigned to the intervention and control groups by simple random sampling. For each of the two intervention and control groups, 30 people will be considered (60 people in total). In this study, a simple randomization method was used to perform random allocation (allocation concealment).In this way, 60 cards that were identical in appearance were prepared and on 30 of them, the number or code 1, which identifies the test group, ie counseling based on positive psychology, and on the other 30 of them, the number or code 2, which identifies The control group was included. Then, each eligible person randomly selected one of these cards with the codes written on it. In this way, the random allocation of patients to each group was determined.
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 Kermanshah University of Medical Sciences
Street address
Burn unit, Imam Khomeini Hospital- Naghlieh Street
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.KUMS.REC.1399.1202

Health conditions studied

1

Description of health condition studied
Body image
ICD-10 code
F88
ICD-10 code description
Other disorders of psychological development

Primary outcomes

1

Description
Body image
Timepoint
At the beginning of the study (before the intervention) and at the end of the study (counseling based on positive psychology)
Method of measurement
Multidimensional body-self relations questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After obtaining informed consent, eligible samples are divided into two groups of intervention A and control B (each group includes 30 people) by simple random sampling method. Patients with grade 2 or higher burns who also need follow-up care for at least one month are selected. The purpose and method of conducting the research is explained to them by the researcher. At first, both groups are given a body image pre-test questionnaire (this questionnaire is a 46-item test.The six-dimensional test questions measure body-self relations, including face evaluation, face orientation, fitness evaluation, fitness orientation, mental weight, and physical satisfaction on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). . To complete it, and then Group A, which includes 30 randomly selected patients, according to the patients' condition, counseling sessions based on positive psychology by the researcher with the approval of the relevant professors in a quiet environment located in the examination room of the burn clinic, at the time Patients are expected to visit a doctor and undergo treatment according to the agreement with the patients and will be done with their companions for 60 minutes, in order not to meet groups A and B, the time of group A meetings is even days and the time of group B meetings are considered individual days. The content of training sessions after extracting from reliable sources The concept of positivity, teaching happiness skills, the concept of appreciation and hope, the meaning of life, as well as consulting with professors is designed in 6 sessions.In the last session, closing and thanking the members, presenting a summary of the topics of the sessions to the members, completing the post-test questionnaires.
Category
Behavior

2

Description
Control group: Group B or the control group, which includes 30 randomly selected patients, is first given a body image pre-test questionnaire (this questionnaire is a 46-item test. The body measures fitness orientation, mental weight, and physical satisfaction on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree).In order not to meet in groups A and B, the time of group A meetings is considered as even days and the time of group B meetings is considered as individual days. However, training and counseling sessions based on positive psychology are not provided for the control group, and they only receive their usual treatment,After the allotted time, the post-test physical image questionnaire, which was completed at the beginning of the study, was completed by the control group to examine the effectiveness of counseling sessions based on positive psychology.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Kermanshah
Full name of responsible person
Zahra Moradi
Street address
Burn unit, Imam Khomeini Hospital- Naghlieh Street
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 3602
Email
zahra59.moradi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khoda Rahmi
Street address
Building No. 2, Deputy of Research and Technology,Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8258
Email
daftarriasat@kums.ac.ir
Web page address
https://www.kums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra Moradi
Position
Master student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 10, Aram building, Ruhollah Akbari Alley, Khayyam St
City
Kermanshah
Province
Kermanshah
Postal code
6718895617
Phone
+98 83 3726 8030
Email
zahra59.moradi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Rostam Jalali
Position
Associate Professor and Faculty Member of Kermanshah Department of Internal Medicine and Surgery
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery-Isar Square - Dolatabad
City
Kermanshah
Province
Kermanshah
Postal code
6718895617
Phone
+98 83 3816 2532
Email
rjalali@kums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra Moradi
Position
Master student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 10,Aram Building, Rohollah Akbari Alley, Khayyam St.
City
Kermanshah
Province
Kermanshah
Postal code
6718895617
Phone
+98 83 3726 8030
Email
zahra59.moradi@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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the content of counseling sessions, questionnaire information at the beginning and end of the study without the names of the participants, data analysis.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Researchers working in universities and prestigious scientific centers
Under which criteria data/document could be used
In order to view and as a model with permission
From where data/document is obtainable
To the people in charge of the study, including Zahra Moradi and Dr. Rostam Jalali, call 00989183892861, and send an email to zahra59.moradi@gmail.com
What processes are involved for a request to access data/document
Request from the relevant officials and correspond with them by phone and email and provide valid documents
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