Determining the Effect of Peer Education on Anxiety and Background Pain in Patients with Burn
Design
A simple randomized Clinical trial with control group، sample of 86 people in two groups
Settings and conduct
Sampling was performed among burn patients hospitalized at Shahid Motahari Hospital of Tehran affiliated to Iran University of Medical Sciences. Participants were randomly assigned to participate in the study by simple random sampling and divided into two groups of control and intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 65 years; Awareness of time and place; Being able to speak and understand Persian language; Having reading and writing skills; Percentage of burns from 15% to 45% (recorded in the case); ; Expiring Acute Period (Approximately one week according to Burning Reference); burns grade 1 and 2 and 3-level burns;
Exclusion criteria: use any anxiolytic, psychoactive and anti-depressant drugs; Untreated Depression and Cognitive Disease (recorded in the case);having chronic disease like diabetes and arthritis and having physical disabilities، self burning or burning by others
Intervention groups
First group (intervention group): In this group, training will be done on reducing the burn complications by peer.
Group 2 (control group): This group will receive routine training during the study.
Main outcome variables
background pain,
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190312043034N1
Registration date:2019-08-20, 1398/05/29
Registration timing:retrospective
Last update:2019-08-20, 1398/05/29
Update count:0
Registration date
2019-08-20, 1398/05/29
Registrant information
Name
Mohammad Rahim khani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 86701
Email address
rahimkhani.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-24, 1398/02/04
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peer education on anxiety and background pain in patients with burns
Public title
The effect of peer education on anxiety and background pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years
Awareness of time and place
Percentage of burns from 15% to 45% (recorded in the case)
burns grade 1 and 2 and 3-level burns
Burns due to an accident
Exclusion criteria:
Admitted to Burn Intensive Care Unit (BICU)
Not Expiring Acute Period (Approximately one week according to Burning Reference)
Use any anxiolytic, psychoactive and anti-depressant drugs
Having chronic disease like diabetes and arthritis and having no physical disabilities
Having Depression and Cognitive Disease (recorded in the case)
Not having reading and writing skills
Unable to speak and understand Persian language
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization and Draw method
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences,beside Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-03-13, 1397/12/22
Ethics committee reference number
IR.IUMS.REC.1397.1314
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T30.0
ICD-10 code description
Burn of unspecified body region, unspecified degree
Primary outcomes
1
Description
Anxiety Scale in the spielberger anxiety questionnaire
Timepoint
Before and after intervention
Method of measurement
spielberger anxiety questionnaire
2
Description
Score of the background pain in the Visual Analogue Scale
Timepoint
Before and after intervention
Method of measurement
Visual Analogue Scale of pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:At first, among the clients at the Shahid Motahari Hospital burnout clinic 6 eligible peers Qualified to participate in the study as a peer. The training in the intervention group by the peer is held during 3 sessions for 45 to 60 minutes on a day-to-day basis. Anxiety and underlying pain will be measured before and after intervention.
Category
Rehabilitation
2
Description
Control group: The control group will only receive routine training during the intervention. background pain and anxiety will be measured before and after intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari hospital
Full name of responsible person
Dr Mostafa Dehmordee
Street address
Motahari hospital, Rashid yasami st, Vali e asr st, Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 8877 0031
Fax
Email
hospital.motahari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malakouti
Street address
Iran University Of Medical Science, Beside of Milad tower, Hemat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
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
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
Iran University of Medical Sciences
Full name of responsible person
Mohammad Rahim khani
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran university of medical science, side of milad tower, hemat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
rahimkhani.m@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Rahim khani
Position
Master Student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran university of medical science, side of milad tower, hemat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
rahimkhani.m@tak.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Rahim khani
Position
Master student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran university of medical science, side of milad tower, hemat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
rahimkhani.m@tak.iums.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The amount of anxiety, the intensity of the background pain, the percentage of age and sex of burn patients, percentage and burn factor
When the data will become available and for how long
Start the access period 5 months after the results edition
محققین
To whom data/document is available
researchers
Under which criteria data/document could be used
Data usage is allowed by mentioning the source
From where data/document is obtainable
rahimkhani.m@tak.iums.ac.ir m.rahimkhani5854@gmail.com Mohammad rahim khani
What processes are involved for a request to access data/document
Send documentation requests and how to use them to email