Protocol summary

Summary
We conducted this study to evaluate the effect of life skills training on depression, anxiety and stress in patients with burn scars. This study is a randomized clinical trial conducted on 30 patients. Inclusion criteria: general health, disability, disfigurement and scarring from burns on exposed areas of the body, education at least diploma, aged 18 to 50 years, passing at least one month after discharge from the hospital, complete the form informed consent Exclusion criteria: having a severe mental disorder, participation in other programs of improving the quality of life at the same time, more than three days of absence from training sessions. Patients who meet the inclusion criteria are divided into two groups using the table of random numbers. Patients in the intervention group are taught life skills over 12 sessions of 2 hours, 1 time per week. Life skills training package is based on the ten dimensions of life skills of the World Health Organization. Training in the intervention group is conducted by dominant topics Master of psychology. however, in the control group we do not have training. Depression, anxiety and stress before the first and after the last session of training were evaluated in all patients by using questionnaire and then two groups were compared to each other.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201704108177N17
Registration date: 2017-04-14, 1396/01/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-04-14, 1396/01/25
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
2017-05-05, 1396/02/15
Expected recruitment end date
2017-12-06, 1396/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of life skills training on reducing burn patients' depression, anxiety and stress
Public title
The effectiveness of life skills training on reducing depression, anxiety and stress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: general health, disability, disfigurement and scarring from burns on exposed areas of the body, education at least diploma, aged 18 to 50 years, passing at least one month after discharge from the hospital, completing consent form the exclusion criteria: having a severe mental disorder, participation in other programs of improving the quality of life at the same time, more than three days of absence from training sessions
Age
No age limit
Gender
Both
Phase
1-2
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
Central Department of Iran University of Medical Sciences, Tehran
City
Tehran
Postal code
Approval date
2016-12-18, 1395/09/28
Ethics committee reference number
IR.IUMS.REC 1395.95-03-129-28114

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder

Primary outcomes

1

Description
Depression
Timepoint
Before the first and after the last training session
Method of measurement
Depression, Anxiety and Stress Scale DASS

2

Description
Anxiety
Timepoint
Before the first and after the last training session
Method of measurement
Depression Anxiety Stress Scale DASS

3

Description
Stress
Timepoint
Before the first and after the last training session
Method of measurement
Depression Anxiety Stress Scale DASS

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: included 12 sessions of life skills training for 2 hours, 1 time per week by the dominant topics Master of psychology
Category
Behavior

2

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

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
Sima Sadat sharoknia
Street address
Shahid Motahari Burn Hospital, Rashid Yasami Ave, Vali Asr Ave, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Javad Mousavi
Street address
Central Department of Iran University of Medical Sciences, Tehran
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
Motahari Burn Hospital
Full name of responsible person
Sima Sadat Sharoknia
Position
Master of Psychology
Other areas of specialty/work
Street address
Shahid Motahari Burn Hospital, Rashid Yasami Ave, Vali Asr Ave, Tehran
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
Burn Research Center
Full name of responsible person
Mohammad Javad Fatemi
Position
Plastic and Reconstructive surgeon
Other areas of specialty/work
Street address
Hazrat Fatima Hospital, Seyed Jamaledin Asadabadi Ave, Tehran
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
Motahari Hospital
Full name of responsible person
Sima Sadat Sharoknia
Position
Master of Psychology
Other areas of specialty/work
Street address
Shahid Motahari Burn Hospital, Rashid Yasami Ave, Vali Asr Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 8888 4275
Fax
Email
sima_6662003@yahoo.com
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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