Protocol summary

Summary
This study is a randomized clinical trial on 60 patients with deformation due to burn referring to the clinic of Rasht Velayat hospital. Patients are selected through convenience sampling and then randomly divided into two groups of intervention and control. Conor Davidson Resiliency Questionnaire(CD-RISC), Spielberger Anxiety (STAI) and Beck Depression in Second Edition (BDI-II) are completed in both groups before and immediately after the intervention. In this study, resilience training was delivered to intervention group as 8 sessions of 90 minutes and once a week in one of the educational classes at Velayat Hospital of Rasht . The control group received no interventionl. Inclusion Criteria: Aged 30 to 80 years, Patients with burns up to 30%, At least three months after the burn accident, Receive average to high (above 40) anxiety scores in the Spielberger anxiety test, Get a high depression score (above 18) in Beck depression test, Having the ability to understand the materials in Persian.Exclusion criteria:Unwillingness to cooperate and Not participating in In three sessions of training sessions, Presence of mental disorders and mental retardation, Attend the same classes Educational.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017092636434N1
Registration date: 2017-10-05, 1396/07/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-05, 1396/07/13
Registrant information
Name
Samaneh Haghi
Name of organization / entity
Islamic Azad Univercity Tehran Medical Branch
Country
Iran (Islamic Republic of)
Phone
Email address
s_haghi33@yahoo.com
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of resilience training on anxiety and depression in patients with deformation due to burn injuries
Public title
The effect of resilience training on burn patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Aged 30 to 80 years, Patients with burns up to 30%, At least three months after the burn accident, Receive average to high (above 40) anxiety scores in the Spielberger anxiety test, Get a high depression score (above 18) in Beck depression test, Having the ability to understand the materials in Persian.Exclusion criteria:Unwillingness to cooperate and Not participating in In three sessions of training sessions, Presence of mental disorders and mental retardation, Attend the same classes Educational
Age
From 18 years old to 60 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
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
Islamic Azad University Tehran Medical Branch
Street address
Tehran Medical Branch , Islamic Azad UniversityT, khaghani st, shariati Ave , Tehran, Iran
City
Tehran
Postal code
1916893813
Approval date
2016-11-12, 1395/08/22
Ethics committee reference number
IR.IAU.TMU.REC.1395.225

Health conditions studied

1

Description of health condition studied
Burn
ICD-10 code
T20.2, T20
ICD-10 code description
Burn of second degree of head and neck, Burn of third degree of head and neck

Primary outcomes

1

Description
resiliency
Timepoint
Before and 2 months after burn
Method of measurement
Connor-Davidson Resilience Scale questonnaire

Secondary outcomes

1

Description
anxiety-depression
Timepoint
Before and 2 months after burn
Method of measurement
Trait Anxiety Inventory and Beck Depression Inventory-II questionnaires

Intervention groups

1

Description
Resilience training was delivered to the participants through educational sessions and pamphlet. These sessions were held once a week for 8 weeks.
Category
Behavior

2

Description
After completing the questionnaires, the control group is given a booklet
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Samaneh Haghi
Street address
Velayat Hospital, Namjoo St. , Rasht, Guilan, Iran
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Samaneh Haghi
Street address
Central Office of Guilan University of Medical Sciences, Parastar St., Rasht, I.R. Iran
City
Gilan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Islamic Azad Univercity Tehran Medical Branch
Full name of responsible person
Samaneh Haghi
Position
Master of Nursing Student
Other areas of specialty/work
Street address
Tehran Medical Branch , Islamic Azad University T, khaghani st, Shariati Ave , Tehran, Iran
City
Tehran
Postal code
1916893813
Phone
+98 21220066607
Fax
Email
iautmu@iautmu.ac.ir s_haghi33@yahoo.com
Web page address
http://www.iautmu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad Univercity Tehran Medical Branch
Full name of responsible person
Samaneh Haghi
Position
Master of Nursing Student
Other areas of specialty/work
Street address
Tehran Medical Branch , Islamic Azad University T, khaghani st, Shariati Ave , Tehran, Iran
City
Tehran
Postal code
1916893813
Phone
+98 21220066607
Fax
Email
s_haghi33@yahoo.com
Web page address
http://www.iautmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad Univercity Tehran Medical Branch
Full name of responsible person
Samaneh Haghi
Position
Master of Nursing Student
Other areas of specialty/work
Street address
Tehran Medical Branch , Islamic Azad University T, khaghani st, Shariati Ave , Tehran, Iran
City
Tehran
Postal code
1916893813
Phone
+98 21220066607
Fax
Email
iautmu@iautmu.ac.irs_haghi33@yahoo.com
Web page address
http://www.iautmu.ac.ir

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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