Protocol summary

Summary
This study aimed to determine the effects of desensitization method with slow eye movements and reprocessing on the anxiety of pain related to dressing in burn patients who admitted in Qazvin Rajaei hospital. This study is a randomized clinical trial that is based on purposive sampling. Patients who had experienced at least burn dressing change and debridement once will nonrandomly divided into two groups of 30 which 30 patients will be in experimental group and 30 patients will be in control group. In the experimental group anxiety of burn pain before procedure and 45 minutes before going to dressing room with code 1 questionnaire, after procedure and before dressing with code 2 questionnaire will be measure by Burns Specific Pain Anxiety Scale measurements. Also, after dressing and patient back to bed, anxiety of burn pain will be measured with code 3 questionnaire. Control group will receive no intervention and only the anxiety of burn pain will be measured before and after dressing change and going to bed by code 4 and code 5 questionnaires, it should be considered that all two groups will receive all treatment procedure equally which physician ordered including sedatives and only for experimental group addition to the things above the intervention will be used.

General information

Acronym
eye movement Desensitization and reprocessing
IRCT registration information
IRCT registration number: IRCT2014060117937N1
Registration date: 2014-09-03, 1393/06/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-09-03, 1393/06/12
Registrant information
Name
Mostafa chatrrooz
Name of organization / entity
Qazvin university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 8127
Email address
mchatrrooz@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2014-03-04, 1392/12/13
Expected recruitment end date
2014-06-08, 1393/03/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of desensitization method with eye movements and reprocessing on anxiety induced by dressing pain in burn patients
Public title
anxiety of pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Grade 2 burn which diagnosed by specialist physician؛ Patients have passed the acute phase of illness؛ Patients didn’t have a history of seizures؛ The level of education should be higher than fifth grade؛ Patients didn’t have a history of mental illness؛ Patients who dont have drug addiction؛ Patients were between 18 and 60 years old؛ Patients shouldn’t have strabismus or vision problems؛ Patients should be able to speak and understand Persian language؛ Patients shouldn’t have burns on head, face and respiratory system؛ Patients experienced dressing change at least once after their admission. Exclusion criteria: Patients are not able to tolerate the treatment method؛ Patients don’t cooperate with the therapist؛ Patients who candidate for skin graft surgery after choose.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Qazvin university of Medical Sciences Ethics Committee
Street address
Nursing Faculty,Qazvin University of Medical Sciences, Bahonar Blv, Qazvin
City
Qazvin
Postal code
3419759811
Approval date
2014-02-26, 1392/12/07
Ethics committee reference number
28/20/8489

Health conditions studied

1

Description of health condition studied
Burn patients
ICD-10 code
T20-T32
ICD-10 code description
Burns and corrosions

Primary outcomes

1

Description
Anxiety of burn pain
Timepoint
Ninety-six days simultaneously in the intervention and control groups
Method of measurement
Burns Specific Pain Anxiety Scale

Secondary outcomes

1

Description
Outcome of patient care
Timepoint
Ninety-six days simultaneously in the intervention and control groups
Method of measurement
Burns Specific Pain Anxiety Scale

Intervention groups

1

Description
Patients in intervention group should do the followings with the guidance and cooperation of therapist. The visual embodiment of an image most prominent of the traumatic scene. Focusing on the negative cognition of the scene that is expressed as a brief description to explain the traumatic event before, for example I’m guilty or that scene was really heartbreaking and horrible for me. Focus on emotions and physical conditions related to stress and anxiety, and expressing the location of stress or anxiety on body parts. Visual following of therapist finger motions in the state of continuing imaging the traumatic scene by patient, patient should follow the rapid therapist finger motions which are in across of his/her vision sight with rapid eye movements. The finger of therapist should be away from patient’s eyes approximately 30 cm and it should be moved from right to left and vice versa in patient vision sight. This movement involves two went and back to the sides within one second that is one cycle and each 12 to 24 cycles are one series. After each series, the therapist says to the patient that stops the imaging of the scene and sits back on seat and takes a deep breath. Then therapist who earlier rated the levels of anxiety units or mental discomfort and cognitive credibility with cooperation of patient, attempting to rate and re-evaluation of these two variables by the patient, and will record them. This process will repeated several times according to the patient’s needs and level of motivation and if possible it will repeated so extent till the levels of mental discomfort units meets the zero and minimized. Session lasts up to 90 minutes.
Category
Other

2

Description
Control group: the group that will receive the standard treatment ordered by the physician according to the hospital protocol by staff and the interventions will not be performed by the researcher.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaei Hospital
Full name of responsible person
Mostafa chatrrooz
Street address
Nursing Faculty, Qazvin University of Medical Sciences, Bahonar Blv, Qazvin
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin university of Medical Sciences
Full name of responsible person
Dr Zinat jourabchi
Street address
Nursing Faculty, Qazvin University of Medical Sciences, Bahonar Blv, Qazvin
City
Qazvin
Grant name
د/7/پ
Grant code / Reference number
28/6/8497
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Mostafa chatrrooz
Position
M.S. student in nursing
Other areas of specialty/work
Street address
Nursing Faculty, Qazvin University of Medical Sciences, Bahonar Blv, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3333 8127
Fax
Email
mchatrrooz@qums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mostafa chatrrooz
Position
M.S. student in nursing
Other areas of specialty/work
Street address
Nursing Faculty, Qazvin University of Medical Sciences, Bahonar Blv, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3333 8127
Fax
Email
mchatrrooz@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mostafa chatrrooz
Position
M.S. student in nursing
Other areas of specialty/work
Street address
Nursing Faculty, Qazvin University of Medical Sciences, Bahonar Blv, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3333 8127
Fax
Email
mchatrrooz@qums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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