Compare auditory distraction and visual distraction on pain and anxiety associated with dressing changes in elderly patients with burns during wound dressing change
Design
Single -blind clinical trial with block randomized allocation and parallel group design
Settings and conduct
The population of all burn elderly patients referred to the Motahari hospital for dressing change burn wounds. Assignment of patients to three groups is carried out by a statistical expert by using blocks. Each sample group includes 35 patients. Demographic and clinical characteristics of the patients will be recorded with questionnaire. For the auditory distraction intervention group nature based sounds and in visual distraction intervention group films about nature will be done for 20 minutes.
Participants/Inclusion and exclusion criteria
The desire to participate in the study؛ Age between 60-75 years old؛ Lack of addiction to drugs and alcohol؛ Lack of cognitive impairment؛ Lack of vision or hearing problems؛ Lack of psychosocial disorders؛ No other injury except of burning lesion؛ No previous record of burns؛ Burn of less than 25% second-degree؛ Burns on the upper and lower extremities؛ Less than 72 hours from the burns happening؛ Absence of self-immolation.
Exclusion criteria: patient dissatisfaction to continue participation in the study pain؛ existence in the other parts of body
Intervention groups
In the auditory distraction intervention group, nature based sounds will be done for 20 minutes before dressing. In the visual distraction intervention group, films about nature will be done for 20 minutes before dressing.In the control group, before dressing no intervention will be done for the patients.
Main outcome variables
In each group the intensity of pain, anxiety, and vital signs will be evaluated before intervention, after intervention and finally after dressing change.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110912007529N21
Registration date:2020-02-17, 1398/11/28
Registration timing:registered_while_recruiting
Last update:2020-02-17, 1398/11/28
Update count:0
Registration date
2020-02-17, 1398/11/28
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-22, 1398/05/31
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare auditory distraction and visual distraction on pain, anxiety and vital sign undergoing dressing changes of burns in elderly people
Public title
The effect distraction on patients undergoing dressing change
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
Age between 60-75 years old
Lack of addiction to drugs and alcohol
Lack of cognitive impairment
Lack of vision or hearing problems
Lack of psychosocial disorders
No other injury except of burning lesion
No previous record of burns
Burn of less than 25%
Second-degree burns on the upper and lower extremities
Less than 72 hours from the burns happening
Absence of self-immolation
Exclusion criteria:
patient dissatisfaction to continue participation in the study
pain existence in the other parts of body
Age
From 60 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization which the patient was the randomization unit. Assignment of patients to the intervention and control group is carried out by a statistical expert by using blocks of 3 with with the help of statistical software minitab and using random numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
Samplers and the statistical analyzer will be blind to patients ‘allocation of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shaded University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2019-06-30, 1398/04/09
Ethics committee reference number
IR.SHAHEEED.REEC.1398.049
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
Burns and
ICD-10 code description
T20-- T25
Primary outcomes
1
Description
intensity of pain
Timepoint
The intensity of pain will be evaluated before intervention, after intervention and finally after dressing change.
Method of measurement
Visual Pain Scale
2
Description
Pain Anxiety
Timepoint
The intensity of pain will be evaluated before intervention, after intervention and finally after dressing change.
Method of measurement
Burn Specific Pain Anxiety Scale (BSPAS)
Secondary outcomes
1
Description
Blood pressure
Timepoint
The blood pressure will be evaluated before intervention, after intervention and finally after dressing change.
Method of measurement
Check list
2
Description
Respiratory rate
Timepoint
The respiratory rate will be evaluated before intervention, after intervention and finally after dressing change
Method of measurement
Check list
3
Description
heart rate
Timepoint
The heart rate will be evaluated before intervention, after intervention and finally after dressing change
Method of measurement
Check list
Intervention groups
1
Description
In the auditory distraction intervention group, nature based sounds about nature will be done for 20 minutes. Dressing wound will be change.The intensity of pain, anxiety, and vital signs will be evaluated before intervention, after intervention and finally after dressing change.
Category
Prevention
2
Description
In the visual distraction intervention group, films about nature will be done for 20 minutes. Dressing wound will be change.The intensity of pain, anxiety, and vital signs will be evaluated before intervention, after intervention and finally after dressing change.
Category
Prevention
3
Description
Control group: before dressing no intervention will be done for the patients. The intensity of pain, anxiety, and vital signs will be evaluated before intervention, after intervention and finally after dressing change