Protocol summary

Summary
We conducted this study to evaluate the effect of life skills training on social adjustment and self-esteem of burn patient with burn scars. this study is a randomized clinical trial on 30 patients. Inclusion criteria: public health, disability, disfigurement and scarring caused by burn on exposed areas of the body, education level of at least diploma, age of 18 to 50 years old, passing at least one month after discharge from hospital, completing consent form. Exclusion criteria: having a severe mental disorder, participating in other life quality improvement programs at the same time, more than three days of absence from training sessions. Patients who meet the entry requirements according to the study, will be divided into two groups using the table of random numbers. Patients in the intervention group during 10 sessions of 2 hours, are trained 3 times a week in life skills. Life skills training package is on the basis of the aspects of life skills according to the World Health Organization. Training in the Intervention group will be done by a master of psychology mastered in related issues, but in the Control group training is not accomplished. All patients in both groups are compared and assessed before the start and after the last training session by the questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201602288177N13
Registration date: 2016-04-20, 1395/02/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-20, 1395/02/01
Registrant information
Name
Mohammad Javad Fatemi
Name of organization / entity
Burn Research Center of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 4275
Email address
mj-fatemi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-04-04, 1396/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of life skills training on self-esteem and social adjustment of burn patients
Public title
The effectiveness of life skills training on self-esteem and social adjustment of burn patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: public health, disability, disfigurement and scarring caused by burn on exposed areas of the body, education level of at least diploma, age of 18 to 50 years old, passing at least one month after discharge from hospital, completing consent form exclusion criteria: having a severe mental disorder, participating in other life quality improvement programs at the same time, more than three days of absence from training sessions
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: 30
Randomization (investigator's opinion)
Randomized
Randomization description
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
Iran University of Medical Sciences
Street address
Tehran, Central building of the University of Medical Sciences
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.IUMS.REC.1394-24970

Health conditions studied

1

Description of health condition studied
Social adjustment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Self-esteem
Timepoint
Before the first training session and after the last training session
Method of measurement
Coopersmith self-esteem questionnaire

Secondary outcomes

1

Description
Social adjustment
Timepoint
Before the first training session and after the last training session
Method of measurement
Standard social adjustment questionnaire

Intervention groups

1

Description
Intervention group: 10 sessions of life skills training for 2 hours, 3 times a week by a master of psychology mastered in training topics
Category
Behavior

2

Description
Control group: Patients do not participate in life skills training
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Hospital
Full name of responsible person
Sima Sadat Sharoknian
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Javad Mosavi
Street address
Tehran, Central building of the University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Motahari Hospital
Full name of responsible person
Sima Sadat Sharoknian
Position
Master of psychology
Other areas of specialty/work
Street address
Tehran, Vali-e-asr Avenue, Rashid Yasemi street, Shahid Motahari Hospital
City
Tehran
Postal code
Phone
+98 21 8888 4275
Fax
Email
sima_6662003@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hazrat Fatima Hospital
Full name of responsible person
Mohammad Javad Fatemi
Position
Plastic and reconstructive surgeon
Other areas of specialty/work
Street address
Tehran, Asad Abadi street, Hazrat Fatima Hospital
City
Tehran
Postal code
Phone
+98 21 8871 7272
Fax
Email
mj-fatemi@sins.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Motahari Hospital
Full name of responsible person
Sima Sadat Sharoknian
Position
Master of psychology
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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