Effect of inhaled Entonox on relief pain, anxiety and hemodynamic factors in burned patients during dressing changes in burning ward of Imam Reza (AS) in Birjand in 1394
The aim of this study is to evaluate the effect of inhaled Entonox on relief pain, anxiety and hemodynamic factors burn patients during dressing changes in burn ward of Imam Reza (AS) is in Birjand in 1394. The inclusion criteria for patients with burn percentage between 15% to 60% and not addicted to drugs and exclusion criteria are dangerous reactions in the intervening time will be considered. The study population will be burn unit patients in Birjand Imam Reza Hospital . In this study, 80 patients (according to formula) that they have15 to 60 percent burning and burn two degree will be used. they should passed 24 to 48 hours after their burn. The design of the study, which randomized, double-blind, placebo control is performed. Patients were randomly divided into two groups and the written agreement with the consent of the samples will be taken. And to a questionnaire study of pain, anxiety and hemodynamic factors for the patients and the degree of extraction of these factors and after the intervention group and the control group by inhaling Entonox put under oxygen inhalation and put in the questionnaire again by patients and factors to examine and record the data will be analyzed and analyzed. 8 months time will be considered intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040521390N2
Registration date:2015-12-15, 1394/09/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-15, 1394/09/24
Registrant information
Name
Hassan Eslami Aliabadi
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3272 0116
Email address
h.eslami@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-21, 1395/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of inhaled Entonox on relief pain, anxiety and hemodynamic factors in burned patients during dressing changes in burning ward of Imam Reza (AS) in Birjand in 1394
Public title
Entonox inhalation effect on pain relief
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 20 and 60 years; there is no underlying medical or psychiatric conditions other than burn, burn percentage between 15% to 60%, though second-degree burn, not addicted to drugs or opium; Exclusion criteria: presence of hazardous reactions during intervention.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Birjand University of Medical Science
Street address
Birjand University of Medical Science, Ghafari Street, Birjand
City
Birjand
Postal code
Approval date
2015-05-25, 1394/03/04
Ethics committee reference number
IR.BUMS.1394.37
Health conditions studied
1
Description of health condition studied
Burn, Vital Sign,Anxiety, Pain
ICD-10 code
T21, T22,
ICD-10 code description
Burn and corrosion of trunk, Burn and corrosion of shoulder and upper limb, except wrist and hand, Burn and corrosion of wrist and hand, Burn and corrosion of hip and lower limb, except ankle and foot, Burn and corrosion of ankle and foot, Tachycardia, un
Primary outcomes
1
Description
Pain
Timepoint
30 Minutes befor, At the time of intervention and 30 Minutes after intervention
Method of measurement
VAS Scale
2
Description
Anxiety
Timepoint
30 Minutes befor, At the time of intervention and 30 Minutes after intervention
Method of measurement
BSPAS Scale
3
Description
Hemodynamic Factors
Timepoint
30 Minutes befor, At the time of intervention and 30 Minutes after intervention
Method of measurement
Mmhg for blood preseure, Rate in minute for plus, Percent of blood oxygen saturation
Secondary outcomes
empty
Intervention groups
1
Description
Group Intervention: The intervention group Entonox we have a mixture of 60% nitrogen and 40% oxygen is used. For two minutes before dressing for inhaled through a mask at the time of dressing change will be simple. This process will continue during dressing changes. And pain, anxiety and changes in hemodynamic parameters in three stages once again exactly 30 minutes before the intervention and once in the intervening time will be 30 minutes after the intervention.
Category
Treatment - Drugs
2
Description
Control group: The control group of oxygen will be used as a placebo. For two minutes before dressing will be used at the time of dressing changes and pain, anxiety and changes in hemodynamic parameters will be recorded. And the results are compared.