Objectives: the effect of eye movement desensitization and reprocessing (EMDR) on the phantom limb pain in patients with amputations will be assess
Design: This Study will be a Clinical Trial. Sixty (60) patients with amputations selected by a purposive sampling and randomly will be divide into two experimental and control groups.
Major Inclusion and Exclusion criteria: phantom pain will have experience at least 9 months ; Moderate to severe pain will have at least 4 days a week. Exclusion criteria will be include psychiatric disorders; a history of drug addiction; strabismus
Intervention: in experimental group, EMDR treatment method will be done individually conduct for each patient in the consultation room within 12 one-hour sessions over a month. In the control group, patients no receive any special treatment by the investigator and the samples of control group had received routine care.
main outcome measures : data will gather on phantom limb pain and subjective units of distress at pretreatment and posttreatment .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052328017N1
Registration date:2016-06-13, 1395/03/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-13, 1395/03/24
Registrant information
Name
Mohammad Behnammoghadam
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 5041
Email address
m.behnammoghadam@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yasooj University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eye movement desensitization and reprocessing on phantom limb pain in patients with amputation
Public title
The effect of eye movement desensitization and reprocessing on phantom limb pain in patients with amputations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: at least 9 months of phantom pain experience; a moderate to severe pain at least 4 days a week.
exclusion criteria: consisted of psychiatric disorders; a history of epilepsy; a history of drug addiction; visual disturbances and strabismus; systemic diseases that affect the central nervous system; lack of cooperation with the therapist; and intolerance to treatment method.
Age
From 27 years old to 59 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
Randomization Will be based on a random numbers table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Sciences
Street address
Shahid Motahari Blvd, Yasuj
City
Yasuj
Postal code
Approval date
2015-11-20, 1394/08/29
Ethics committee reference number
ir.yums.rec.1395.26
Health conditions studied
1
Description of health condition studied
Amputation
ICD-10 code
------
ICD-10 code description
------
Primary outcomes
1
Description
Phantom limb pain
Timepoint
One month
Method of measurement
Numerical pain scale
Secondary outcomes
1
Description
Subjective units of distress
Timepoint
One month
Method of measurement
Subjective units of distress scale
Intervention groups
1
Description
"Intervention group: EMDR treatment method will be done individually conduct for each patient in the consultation room within 12 one-hour sessions over a month. In each session, the two scales of Subjective units of distress and pain rating scale will recomplete by patients before and after the intervention".
Category
Treatment - Other
2
Description
"Control group: patients did not receive any special treatment by the investigator and the samples of control group had received routine care".
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh Medical Clinic of Yasuj
Full name of responsible person
Mohammad Behnammoghadam, Master of Critical Care Nursing
Street address
Montazeri Street, Yasuj
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Yasuj University of Medical Sciences
Full name of responsible person
Dr. Mousavi
Street address
Shahadat 12, Bagher Khan Blvd, Yasuj
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Yasuj 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
Yasuj University Of Medical Sciences
Full name of responsible person
Mohammad Behnammoghadam
Position
MSc
Other areas of specialty/work
Street address
Yasuj University Of Medical Sciences
City
Yasuj
Postal code
Phone
+98 74 3322 5041
Fax
Email
mbehnam1363@gmail.com; mbehnammoghadam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University Of Medical Sciences
Full name of responsible person
Mohammad Behnammoghadam
Position
MSc
Other areas of specialty/work
Street address
Shahadat 12, Bagher Khan Blvd, Yasuj
City
Yasuj
Postal code
Phone
+98 74 3322 5041
Fax
Email
mbehnammoghadam@yahoo.com; mbehnam1363@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Mohammad Behnammoghadam
Position
Msc
Other areas of specialty/work
Street address
Shahid Motahari Blvd, Yasuj
City
Yasuj
Postal code
7591959497
Phone
+98 74 3322 5041
Fax
+98 74 3322 5041
Email
mbehnammoghadam@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)