Determining the effect of acupressure on the pain and anxiety caused by changing the dressing in burn victims.
Design
Clinical trials with control group, randomized, parallel groups, double blinded
Settings and conduct
This interventional study is a three-group double-blind clinical trial, designed to determine the effect of ear acupressure on the pain and anxiety caused by dressing change in burned patients. The statistical population of this study includes the patients hospitalized in the burn intensive care unit of Zare Hospital in Sari.the statistics specialist and assessor are blind to the intervention
Participants/Inclusion and exclusion criteria
Inclusion Criteria: aged over 18, alert, unintentional burns of grade 2 and 3 less than 35%, being in the acute phase of burn,The absence of a history of mental disorders, including depression and anxiety, Having a natural auricle without legion and pain, Lack of use of acupressure in the past, no burns on face, neck, and ears.
Exclusion Criteria: Drug Addiction,Pregnancy
Intervention groups
The intervention includes ear acupressure and control group only receive the routine care about pain relief.
Main outcome variables
Pain and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180228038898N1
Registration date:2018-08-05, 1397/05/14
Registration timing:registered_while_recruiting
Last update:2018-08-05, 1397/05/14
Update count:0
Registration date
2018-08-05, 1397/05/14
Registrant information
Name
Mohammadreza Zakeri Sanate
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3332 6817
Email address
m.zakeri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of auricular acupressure on anxiety and pain during dressing change in burn victims in critical care unit
Public title
The effect of auricular acupressure on anxiety and pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged over 18, alert, unintentional burns of grade 2 and 3 less than 35%, being in the acute phase of burn,The absence of a history of mental disorders, including depression and anxiety, Having a natural auricle without legion and pain, Lack of use of acupressure in the past, no burns on face, neck, and ears.
Exclusion criteria:
Drug Addiction, Pregnancy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible patients are selected using convenience sampling method and then, using random numbers table, samples will be divided into three groups A, B and C.
Blinding (investigator's opinion)
Double blinded
Blinding description
The statistician is also blind to the intervention.Variables are measured by the assessor (a trained nurse) who is blind to blind intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Start of valiye asr highway, Imam Square, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4736131167
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.MAZUMS.REC.1397.001
Health conditions studied
1
Description of health condition studied
Burns and corrosions
ICD-10 code
T20-T32
ICD-10 code description
Burns and corrosions
Primary outcomes
1
Description
pain
Timepoint
30 minutes before the intervention, immediately after the dressing, 15 minutes, 30 minutes and 60 minutes after
Method of measurement
visual analouge scale
2
Description
anxiety
Timepoint
30 minutes before the intervention, immediately after the dressing, 15 minutes, 30 minutes and 60 minutes after
Method of measurement
Burn specific Pain Anxiety Scale
Secondary outcomes
1
Description
blood pressure
Timepoint
Before the intervention and 60 minutes after the intervention
Method of measurement
Barometer device
2
Description
Pulse
Timepoint
Before the intervention and 60 minutes after the intervention
Method of measurement
Touch
Intervention groups
1
Description
Intervention group: the patients in the intervention group receive acupressure at the Shenmen point in the upper wall of the ear cavity.The method of applying pressure to the units under study in the intervention group is that the researcher pushes the finger using the index finger on the stench of the ear for two minutes so that the person feels heavy, warm, or numb.
Category
Treatment - Other
2
Description
Intervention group: The sham group receives acupressure treatment in a false point;which is not effective according to acupressure philosophy. This point is at the beginning of the ear cavity.
Category
Treatment - Other
3
Description
control group: only receive the routine care about pain relief.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare Hospital
Full name of responsible person
Mohammad Reza Zakeri
Street address
Imam Reza Blvd
City
Sari
Province
Mazandaran
Postal code
481476665
Phone
+98 11 3328 3886
Email
zakerimohamadreza@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Ahmadali Enayati
Street address
Moalem Street ,Moalem Square
City
Sari
Province
Mazandaran
Postal code
4814766665
Phone
+98 11 3332 6817
Email
tf@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mohamad Reza Zakeri
Position
MSC in Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nasibeh School of Nursing and Midwifery, , Sari
City
Sari
Province
Mazandaran
Postal code
48197-53171
Phone
+98 11 3336 7342
Email
zakerimohamadreza@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Seyed Afshin Shorofi
Position
PHD in nursing/ faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
48197-53171
Phone
+98 11 3336 7342
Email
afshinshorofi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohamad Reza Zakeri
Position
MSC in Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nasibeh School of Nursing and Midwifery, , Sari
City
Sari
Province
Mazandaran
Postal code
48197-53171
Phone
+98 11 3332 6817
Email
zakerimohamadreza@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