This study is done to evaluate the effect of Benson relaxation on pain anxiety and pain intensity of dressing change in burn patients. The sample group consist of 90 patients who are randomly divided equally into two intervention and control group (the member of each group=45). The members of intervention group listen to relaxation audio files 30 minutes and they do what they hear after completing a training course and on the next turn of dressing change before entering the dressing room. People with 2 and 3 burn degree by age of 18-60 can participate in this study. People who have skin surgery or they are in the list of biological dressing can’t participate in the study.
Primary outcome: It is expected that Benson's relaxation be effective on pain intensity and pain associated with dressing change in burn patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091429817N1
Registration date:2017-02-11, 1395/11/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-11, 1395/11/23
Registrant information
Name
Esmat Nuhi
Name of organization / entity
Kerman University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5220
Email address
e_nuhi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Is paid privately
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-19, 1395/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Benson Relaxation thraphy on anxiety pain and pain intensity of dressing changes In burn patients
Public title
The effect of Muscular Relaxation thraphy on anxiety pain and pain intensity of dressing changes in burn patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: They have 2 or 2 and 3 degree burn wounds; their ages are between 18 to 60; they able to understand and speak Persian; they don’t have burns in their heads and necks; they experience one dressing at least; they have no history of mental illness; no absence of neurological disorders; no numbness in the limbs burned and they also don’t have hearing or vision problems.
Exclusion criteria: patients who are not able to cooperate in order to implement the method for whatever reasons are excluded; they don’t able to achieve necessary skills relaxation Benson; they are selected to skin graft surgery; their names are in the biological dressing list.
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:
90
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
Kerman University of Medical Sciences Ethics Committee
Street address
Campus University of Medical Sciences, beginning around seven gardens Alavi, Kerman
City
Kerman
Postal code
Approval date
2016-04-18, 1395/01/30
Ethics committee reference number
IR.Kmu.REC.1395.01
Health conditions studied
1
Description of health condition studied
burning
ICD-10 code
T29.6
ICD-10 code description
Corrosions of multiple regions, no more than second-degree corrosions mentioned
2
Description of health condition studied
burning
ICD-10 code
T29.7
ICD-10 code description
Corrosions of multiple regions, at least one corrosion of third degree mentioned
Primary outcomes
1
Description
pain intensity
Timepoint
before intervention and half an hour after the intervention
Method of measurement
Linear scale pain
2
Description
Anxiety pain
Timepoint
Before intervention and half immediately after the intervention
Method of measurement
Burn Specific Pain Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
The members of intervention group listen to relaxation audio files 30 minutes and they do what they hear after completing a training course and on the next turn of dressing change before entering the dressing room.
Category
Behavior
2
Description
The control group, only routine procedures done
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shifa Hospital
Full name of responsible person
Azam Shahabi
Street address
Medical Education Center ُُShifa, Kosar Blvd, Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences VCR
Full name of responsible person
Dr.Abbas Pardakhty
Street address
Campus University of Medical Sciences, beginning around seven gardens Alavi, Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences VCR
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
Kerman University of Medical Sciences
Full name of responsible person
Azam Shahabi
Position
Master Of Medical Sergical Nersing
Other areas of specialty/work
Street address
Campus University of Medical Sciences, beginning around seven gardens Alavi, Kerman
City
Kerman
Postal code
Phone
+98 34331325220
Fax
+98 34 3211 5783
Email
hannaneh.shahabi@gmail.com
Web page address
www.kmu.ac,ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Doctor Esmat. Nouhi
Position
PhD
Other areas of specialty/work
Street address
Campus University of Medical Sciences, beginning around seven gardens Alavi, Kerman
City
KERMAN
Postal code
Phone
+98 34331325220
Fax
Email
e_nuhi@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Azam Shahabi
Position
Master Of Medical Sergical Nursing
Other areas of specialty/work
Street address
Campus University of Medical Sciences, beginning around seven gardens Alavi, Kerman
City
Kerman
Postal code
Phone
+98 34311325220
Fax
+98 34331325218
Email
Web page address
ٌwww.kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)