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Impact of Guided Imagery Implementation on the Quality and Severity of Pain, and Pain Anxiety of Change Dressing in Patients with Burn Injury

Protocol summary

Study aim
Impact of Guided Imagery Implementation on the Quality and Severity of Pain, and Pain Anxiety of Change Dressing in Patients with Burn Injury
Design
Clinical trial with control group with pretest posttest design with Two arm parallel group randomised with Unilateral blinding
Settings and conduct
30 eligible individuals have selected for intervention in Imam Khomeini hospital of urmia in burn section , in zero session before dressing, pain anxiety, pain intensity and quality will be measured, then the audio file will be played with active visualization with headset, and pain anxiety will be measured again before entering the dressing room.we ask patient to apply this technique in the dressing room, then after dressing, the quality and intensity of the pain will be re-measured, procedure being performed daily for four consecutive day.
Participants/Inclusion and exclusion criteria
age range: 18-60, Emergency stage (72-48 hours after burn injury until complete wound closure) have been passed and the patients have been in the subsequent stages of burn injury (acute and rehabilitation), Patients with secondary degree burns with a burn level between 9-35%, No burns in the neck and face, Ability to speak Persian, not have severe hearing or visual impairment, Willing to participate in study, not have a history of mental illness, not have a history of burns.
Intervention groups
In intervention group(n=30), in zero session before the dressing, pain anxiety, pain intensity and quality will be measured, then the audio file will be played with active visualization, and pain anxiety will be measured again before entering the dressing room.we ask patient to apply this technique in the dressing room, then after dressing, the quality and intensity of the pain will be re-measured, procedure being performed daily for four consecutive day.
Main outcome variables
Pain anxiety, severity of pain, quality of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180813040786N1
Registration date: 2020-04-04, 1399/01/16
Registration timing: retrospective

Last update: 2020-04-04, 1399/01/16
Update count: 0
Registration date
2020-04-04, 1399/01/16
Registrant information
Name
Nader Aghakhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4916
Email address
naderaghakhani2000@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2019-08-01, 1398/05/10
Actual recruitment end date
2019-12-26, 1398/10/05
Trial completion date
2019-12-26, 1398/10/05
Scientific title
Impact of Guided Imagery Implementation on the Quality and Severity of Pain, and Pain Anxiety of Change Dressing in Patients with Burn Injury
Public title
Impact of Guided Imagery Implementation on the Quality and Severity of Pain, and Pain Anxiety of Change Dressing in Patients with Burn Injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People between the ages of 18-60. Emergency stage (72-48 hours after burn injury until complete wound closure) have been passed and the patients have been in the subsequent stages of burn injury (acute and rehabilitation). Patients with secondary degree burns with a burn level between 9-35%. No burns in the neck and face. Ability to speak Persian Do not have severe hearing or visual impairment Willing to participate in the study. The patient does not have a history of mental illness The patient does not have a history of burns.
Exclusion criteria:
The patient dose have burns in the neck and face area The patient dose have severe hearing or visual impairment The patient does have a history of mental illness The patient does have a history of burns.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Data analyser
Sample size
Target sample size: 56
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, for random allocation we used biased coin method in individual randomization unit by coin toss, and each person who was eligible for the study with fliping a coin divided to intervention group if it was heads and control group if it was tails.
Blinding (investigator's opinion)
Single blinded
Blinding description
Clinical caregivers and data analyzer were unaware of the control and intervention groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Resalat Ave, Emergency Alley, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-07-17, 1398/04/26
Ethics committee reference number
IR.UMSU.REC.1398.167

Health conditions studied

1

Description of health condition studied
Burn of second degree of trunk
ICD-10 code
T21.2
ICD-10 code description
Burn of second degree of trunk

2

Description of health condition studied
Burn of second degree of shoulder and upper limb, except wrist and hand
ICD-10 code
T22.2
ICD-10 code description
Burn of second degree of shoulder and upper limb, except wrist and hand

3

Description of health condition studied
Burn of second degree of wrist and hand
ICD-10 code
T23.2
ICD-10 code description
Burn of second degree of wrist and hand

4

Description of health condition studied
Burn of second degree of lower limb, except ankle and foot
ICD-10 code
T24.2
ICD-10 code description
Burn of second degree of lower limb, except ankle and foot

5

Description of health condition studied
Burn of second degree of ankle and foot
ICD-10 code
T25.2
ICD-10 code description
Burn of second degree of ankle and foot

Primary outcomes

1

Description
The patients' baseline pain intensity was measured at session zero before dressing replacement and then measured in four consecutive steps daily before and after dressing.
Timepoint
Meeting0, meeting1(day1), meeting2(day2), meeting3(day3), meeting4(day4)
Method of measurement
The Short Form of Mc Gill Pain Questionnaire

2

Description
The patients' baseline pain quality was measured at session zero before dressing replacement and then measured in four consecutive steps daily before and after dressing.
Timepoint
Meeting0, meeting1(day1), meeting2(day2), meeting3(day3), meeting4(day4)
Method of measurement
Visual Analogue Scale (VAS)

3

Description
The patients' baseline pain anxiety was measured at session zero before dressing replacement and then measured in four consecutive steps daily before dressing.
Timepoint
Meeting0, meeting1(day1), meeting2(day2), meeting3(day3), meeting4(day4)
Method of measurement
The abbreviated burn specific pain anxiety scale

Secondary outcomes

empty

Intervention groups

1

Description
Control group: This group includes people who have had second-degree burns and change their dressings daily at the specified hour, and their anxiety level for half an hour before going to the dressing room and the severity of pain and pain quality immediately after dressing change have controlled, no intervention have done in this group. These are measured in four consecutive days of 0 to 4 sessions.
Category
N/A

2

Description
Intervention group:In this group, the audio file (guided imagery) is played through the headphones before going to the dressing room, then the anxiety level is measured half an hour before the dressing change, and immediately after the dressing, the quality and severity of pain are measured. These are measured in four consecutive days of 0 to 4 sessions.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Navid faraji
Street address
Imam Khomeini Hospital, Ershad Ave., Urmia, I.R.IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Fax
+98 44 3346 9935
Email
academic.relations@umsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Resalat Ave, Emergency Alley, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Fax
+98 44 3193 7224
Email
mohebbi_iraj@yahoo.co.uk
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo Campus Building of School of Nursing and Midwifery, Orumieh - 11 Km, West Azarbaijan, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4916
Email
Naderaghakhani2000@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo Campus Building of School of Nursing and Midwifery, Orumieh - 11 Km, West Azarbaijan, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4916
Email
Naderaghakhani2000@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo Campus Building of School of Nursing and Midwifery, Orumieh - 11 Km, West Azarbaijan, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4916
Email
Naderaghakhani2000@gmail.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
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