The research aims is investigating the effect of pain control through relaxed breathing Technique in patients referring to Burn Clinic of Rasht during burn dressing procedure.
Design
A randomized controlled clinical trial with parallel groups, without blinding, will be conducted for 62 patients. Random Allocation Software will be employed for randomization.
Settings and conduct
All patients who referred to Velayat Burn Center of Rasht will be included in the study provided that they meet the selection criteria, The sampling will be performed based on the gradual referral of patients to the center. The patients assignment to 2 groups of A ( receiving breathing training) and B (receiving routine burn care) will be based on their conformity with selection criteria, the 4- Block Randomization procedure, and the order determined through Random Allocation Software prior to the beginning of the study. The list, of patients, will be kept in sealed envelope in the Burn Research Center or the Nursing Office to be read daily and in orderly manner at the beginning of the study.
Participants/Inclusion and exclusion criteria
The participants with second-degree burns and above 15 years of age, will join the study after obtaining their informed consent. The patients with neuropathic symptoms, use of narcotics, inability to communicate pain intensity, chemical and electrical burns, burns extending over more than one anatomical areas and those hospitalized for burn severity will be excluded from the study.
Intervention groups
Patients suffering from second-degree burns with no neuropathic symptoms who seek dressing change in Burn Clinic of Rasht in 2020 will be included in the study.
Main outcome variables
The severity of pain in burned surface area of both groups will be assessed using the Visual Analogue Scale (VAS). Also, the Burn Specific Pain Anxiety Scale, will be employed to assess pain anxiety.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210424051062N1
Registration date:2021-06-07, 1400/03/17
Registration timing:retrospective
Last update:2021-06-07, 1400/03/17
Update count:0
Registration date
2021-06-07, 1400/03/17
Registrant information
Name
Naghmeh Bozorgnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3333 3448
Email address
n.bozorgnia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-26, 1400/02/06
Expected recruitment end date
2021-05-27, 1400/03/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Breathing Technique Training Effectiveness on Pain Control in Outpatients During Burn Care
Public title
Breathing Technique Training Effectiveness on Pain Control in Outpatients During Burn Care
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The participants’ consent to join the research
The participants must be over 15 years old.
The participants’ TBSA should be less than 20.
The participant have a second degree burns.
Exclusion criteria:
Neuropathic symptoms
Use of narcotics before referring to burn clinic
Inability to communicate pain intensity
Non-chemical burn
Non-electrical burn
Burn extending over more than one anatomical regions
Burns leading to hospitalization
Inability to learn and use technique
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomly assigned to respective groups following the 4- block randomization procedure. The list will be kept in a sealed envelope in the Burn Research Center or the Nursing Office to be read daily and in an orderly manner at the beginning of the study.
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
Medical Ethics Committee of Guilan University of Medical Sciences
Street address
Shahid Siadati St., Namjoo Street, Rasht
City
Rasht
Province
Guilan
Postal code
4144654379
Approval date
2021-02-03, 1399/11/15
Ethics committee reference number
IR.GUMS.REC.1399.568
Health conditions studied
1
Description of health condition studied
Burn of second degree, body region unspecified
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before and after training
Method of measurement
It will be evaluated using visual analog scale (VAS)
2
Description
Anxiety caused by pain
Timepoint
Before and after training
Method of measurement
The Burn Specific Pain Anxiety Scale will be used to assess the level of anxiety caused by patients' pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Initially, the patients’ pain intensity will be assessed employing the Visual Analogue Scale (VAS) by a research team member before starting dressing. The patient will exercise the breathing Technique 5 times during 10-minute dressing care. The pain intensity will be reassessed upon redressing the burn region. The patients, then, will be asked to express the degree of their satisfaction with the burn care procedure in terms of “full satisfaction’, Partial satisfaction” and “dissatisfaction”. The responses will be recorded in the data collection form. The patients with a VAS rate above 3 after the intervention, will be prescribed nonsteroidal anti-inflammatory drugs or acetaminophen as analgesics at the discretion of the physician and the patients' conditions.
Category
Behavior
2
Description
Control group: Control group receives routine burn care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat burning and reconstructive surgery sub-specialty center
Full name of responsible person
Mohammad Reza Mobayen
Street address
Velayat Hospital, Namjoo St.
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 8714
Email
velayathospital@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
Shahid Siadati Ave. – Namjoo St.
City
Rasht
Province
Guilan
Postal code
4144654379
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Mobayen
Position
Assistant Professor of Burn Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Namjoo St,
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 8633
Email
mmobayen@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Mobayen
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Namjoo St.
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 9633
Email
mmobayen@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Naghmeh bozorgnia
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Namjoo St,
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 8633
Email
N.bozorgnia@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available