The effect of a therapeutic recreation program on pain-anxiety and disability in burn patient
Design
Clinical clinical practice with control group, with parallel groups, blind, randomized, randomized software.
Settings and conduct
This study was conducted in the burn ward of Imam Reza Hospital in Mashhad. Patients in the intervention group will use the recreational therapy program for two weeks. In the control group, in the control group, according to routine, activities such as walking in the department, raising, lowering and opening, closing of the hands are done. The burn injuries questionnaire and WHO Disability Assessment Questionnaire will be completed in both groups.
Participants/Inclusion and exclusion criteria
Entry criteria: aged 20 and under 65
Refueling at least 5% and up to 30%
Not having Burn on the legs, wrists and knees
No electrical burn
Mental and physical disability
Exit criteria:
Severe cardiovascular, pulmonary and vascular disorders
The patient's lack of interest in continuing the study
Intervention groups
In the intervention group, a therapeutic recreation program is held for two weeks each week, three sessions of each session for one hour in the evening, after the meeting hour in the department.
Main outcome variables
pain anxiety and disability in burn patient
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181016041359N1
Registration date:2019-01-17, 1397/10/27
Registration timing:prospective
Last update:2019-01-17, 1397/10/27
Update count:0
Registration date
2019-01-17, 1397/10/27
Registrant information
Name
abolfazl saberi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3658 0829
Email address
saberia962@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-03-05, 1397/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Therapeutic Recreation Program on pain-anxiety and disability burn patient
Public title
The Effect of Therapeutic Recreation Program on pain-anxiety and disability burn patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with burns 5 to 30%
Exclusion criteria:
Burn in legs, wrists and knees
Electrical burn
Mental and physical disability
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: This method uses simple randomization models such as milk or line, random number table, or use of computerized randomization methods, and each user can, for example, by dropping coins, milk and line-ups in The intervention group or the control group. The implementation of this method is very simple. The disadvantages of this method is that the sample size of a group may be more than the other. One type of intervention may be given early in the study and a type of intervention at the end of the study.
Randomization unit is parallel
Software is a statistical software randomization tool
Hiding with sealed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researchers and participants are blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Ebn sina Street, Faculty of Nursing and Midwifery, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-12-31, 1397/10/10
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.073
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T20
ICD-10 code description
Burn and corrosion of head, face, and neck
Primary outcomes
1
Description
Pain Anxiety and Disability
Timepoint
Before the intervention, after the study and two weeks after the discharge
Method of measurement
burn specific pain anxiety scale - burn specific health scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A therapeutic recreation program for two weeks each week. Three sessions per session for one hour in the evening, after an appointment, in the intended room in the department so that the first hour of the men and then the women for the next time to perform the activity They enter the room, held in the department. The content of the program consists of six sessions, each session starting with the presentation of the contents of each session to patients and performing stretching, which lasts 10 minutes, the continuation of the program with games that cause mental and physical activity and laugh and joy that is 40 It takes a minute.The main activity of the sessions is: the first session of the game of the tail (a game in which the person should try to catch a scoop tailored for the other person), the second session of the coin and the bowling game with the feet, the third session of the darts throw, Playing Mannequa, Fourth Session Scissors, Volleyball, Fifth Floor Playing Cup, Handball, Sporty Gymnastics, and Sixth Session Using your fingers to remove the sticker behind the card and put it on the board, walking, running tennis table. Finally, the sessions end with sharing the feelings of patients after an activity that lasts 10 minutes. The main content of each session is determined according to the available facilities and patient selection.
Category
Rehabilitation
2
Description
Control group: Control group: According to the routine, activities such as walking in the department, up / down and opening / closing hands are done.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital burn center
Full name of responsible person
Razieh Foroutan(phd)
Street address
Imam Reza Hospital Square-Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University of Mashhad University of Medical Sciences, Department of Research and Technology, University of Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Frootan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebn sina Street, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
froutanr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
razieh forootan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebn sina Street, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
froutanr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abolfazl Saberi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
ebn sina Street, Faculty of Nursing Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3217 8589
Email
saberia962@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD