The purpose of this randomized clinical trial is to investigate the effect of jaw relaxation on pain intensity and anxiety of burn dressing change in hospitalized patients admitted to Shahid Motahari Burn Center in Tehran. Sample: convenience sample of 120 patients, aged 18 to 60, TBSA %9-35, burn degree 2 or 2 and 3, able to speak and understand Persian, wound dressing by wards’ routines, no self-inflicted burn. Sampling procedure: randomly assigned using minimization to either experimental or control groups. Pain intensity and anxiety will be measured with Visual Analogue Scale (VAS) and Burn Specific Pain Anxiety Scale (BSPAS) respectively. Scoring procedure: The scores of each tool range from 0-100. The procedure will be explained to each patient. A written instruction about the procedure will be given to the experimental group. They will practice the technique for 20 minutes before going to dressing room. Pain anxiety will be assessed before and after intervention (before going to dressing room) and after dressing in experimental group. In control group it will be assessed before and after dressing. Pain intensity will be also assessed after dressing in both groups. Finally four structured questions will be asked from experimental group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803202019N1
Registration date:2009-07-25, 1388/05/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-07-25, 1388/05/03
Registrant information
Name
Fahimeh Mohammadi Fakhar
Name of organization / entity
Faculty of Nursing & Midwifery, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 1224 2296
Email address
frafii@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2010-01-21, 1388/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of jaw relaxation on pain of burn dressing change in hospitalized patients of Shahid Motahari Clinical Educational Center in 2009.
Public title
The effect of jaw relaxation on pain of burn dressing change in hospitalized patients of Shahid Motahari Clinical Educational Center in 2009.
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, presence of complications related to neurological disorders leading to numbness in burned tissues, presence of severe visual and/or hearing problems
Exclusion criteria: Inability to do any stages of the procedure for any reason, inability to achieve mastery in jaw relaxation technique for any reason, surgical procedures for skin graft during the study interventions, application of biological dressings to the skin
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Nursing and Midwifery, Iran University of Medical Sciences
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
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)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will receive Jaw relaxation. subjects will be asked to sit in a comfortable semi -fowlers position in their beds and perform the following procedure for 20 minutes: (a) let the lower jaw drop slightly (b) keep the tongue quiet and resting in the bottom of the mouth (c) let the lips get soft (d) breath slowly with a three-rhythm pattern of inhale, exhale, and rest (e) stop forming words and do not even think words. Subjects' ability to use the technique will be verified by observing for four criteria: (a) face relaxed (b) no grimace or frown (c) not talking (d) slow respirations (2 points each). Mastery is defined as a score of 7 out of 8 points.
Category
Behavior
2
Description
Control group: No intervention will be performed
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinical Educational Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. F. Oskouie
Street address
Center for Nursing Care Research 2nd building of School of Nursing and Midwifery, Rashid Yasemi St., Vali-Asr Ave., Po-Box: 19395-4798, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Faculty of Nursing and Midwifery, Iran University of Medical Sciences