The purpose of this randomized clinical trial is to investigate the effect of transcranial direct current stimulation on pain intensity and quality and pain anxiety of burn dressing change in hospitalized patients admitted to the Burn Center of the Emam Reza hospital in Mashhad. Sample: convenience sample of 60 patients, aged 15 to 60, TBSA %20-50, burn degree 2 or 3, able to speak and understand Persian, wound dressing by Dressing acid, povidone iodine. Sampling procedure: randomly assigned using stratification to either experimental or control groups. Pain intensity and quality and pain anxiety will be measured with Visual Analogue Scale (VAS) and the Short Form-McGill Pain Questionnaire and Burn Specific Pain Anxiety Scale (BSPAS) respectively. Scoring procedure: The scores of VAS range from 0-10, BSPAS range from 9-36 and Short Form-McGill Pain Questionnaire range from 0-41. The intervention consisted of 20 minutes of Cathodal somatic sensory cortex stimulation, with the current of 1 mA. While the control group will receive sham stimulation. Pain anxiety will be assessed before and after intervention and after dressing in experimental group. In control group it will be assessed before and after dressing. Pain quality will be also assessed just after dressing. Pain intensity will be assessed before and after dressing in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042817468N1
Registration date:2014-07-25, 1393/05/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-25, 1393/05/03
Registrant information
Name
Meysam Hoseini Amiri
Name of organization / entity
Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 0936
Email address
hoseiniam911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University Of Medical Sciences
Expected recruitment start date
2014-06-30, 1393/04/09
Expected recruitment end date
2014-10-01, 1393/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of non-invasive transcranial direct current stimulation on pain and pain anxiety of burn dressing in Patients with burns
Public title
The effect of transcranial direct current stimulation on pain and pain anxiety of burn in Patients with burns
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients in acute phase of burn injury, thermal burn, absence of face and neck burn, presence of psychological disorders currently or previously, the lack of complications related to neurological disorders leading to numbness in burned tissues, absence of severe visual and/or hearing problems, the absence of tumor and metallic implants in the head and upper back, the lack of brain trauma and epilepsy, absence of severe headaches.
Exclusion criteria: Inability to do any stages of the procedure for any reason.
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University Of Medical Sciences
Street address
Daneshgah street, Taghi abad, Mashhad
City
Mashhad
Postal code
Approval date
2015-02-08, 1393/11/19
Ethics committee reference number
921688
Health conditions studied
1
Description of health condition studied
Burns and corrosions
ICD-10 code
T29, T31
ICD-10 code description
Burns and corrosions of multiple body regions, Burns classified according to extent of body surface involved
Primary outcomes
1
Description
Intensity of burn dressing pain
Timepoint
Before and after intervention (before dressing) and After dressing
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Pain anxiety with burn dressing
Timepoint
Before and after intervention (before dressing) and after dressing in experimental group and also before and after dressing in control group
Method of measurement
Burn Specific Pain Anxiety Scale (BSPAS)
3
Description
Quality of burn dressing pain
Timepoint
After dressing
Method of measurement
The Short Form-McGill Pain Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
This group will receive catodal tDCS. Therefore the cathode electrode will be considered on the areas of right sensory cortex in the dorsal central position of right sulcus and anode electrode will be considered on the left prefrontal cortex, above the left eyebrow.
Category
Treatment - Other
2
Description
This group will receive sham tDCS so that device will turn off after 30 seconds of stimulation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
the Burn Center of the Emam Reza hospital in Mashhad