Effectiveness of eye movement desensitization and reprocessing (EMDR) on pain intensity in cancer patients
Design
Trial has a control and an intervention group with parallel group and unblinded
Settings and conduct
We want patients to visualize the worst picture of pain that is related to cancer and then follow the finger of researcher that is in front of patient face in 30 centimeter distance. Each move, going and getting back, lasts 1 sec. This is called one cycle. 12 to 24 cycles are called a collection. After any collection, we stop the procedure and want patient to take a deep breath. Then patients fill the questionnaires again. This procedure proceed according to the demand and motivation of each patient. This route lasts 30-45 minutes.
Participants/Inclusion and exclusion criteria
Patient with cancer disease according to diagnosis of doctor that at least pass over six months.
Intermediate to severe pain according to pain scale
Do not collaborate during the intervention
Do not tolerate the route of EMDR
Intervention groups
Intervention: for each patient personally the route of EMDR will take place in 3-5 sessions. Before and after intervention both scales(SUD and Pain scales) will filled by patients.The number of patients in this group is 30.
Control: In first session all of questionnaires will filled and then without any intervention questionnaires will filled again.The number of patients in this group is 30.
Main outcome variables
Pain intensity; Distress intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190822044581N1
Registration date:2019-09-21, 1398/06/30
Registration timing:prospective
Last update:2019-09-21, 1398/06/30
Update count:2
Registration date
2019-09-21, 1398/06/30
Registrant information
Name
Naeem Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3222 3853
Email address
naiem.abdi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients
Public title
Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with cancer disease according to diagnosis of doctor that at least pass over six months.
Stabilization of hemodynamic condition
Do not use of relaxation drugs
Intermediate to severe pain according to pain scale
Consciousness and trainable
literacy
Have not any visual disorders
Do not use of narcotics
Do not have any systemic disorders
Exclusion criteria:
Do not collaborate during the intervention
Do not tolerate the route of EMDR
Age
From 15 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
Samples will be allocated randomly by block assignment between the two groups.considering the highest sample size needed for each of the study groups and a possible attrition of 20%, a total of 60 people was estimated as the sample size with 30 people for each group.
During random block assignment, the order of the participants in the intervention and control groups was determined as follows:
By multiplying the number of study groups (two groups) by 2, the number of samples per block was calculated as 4; then, by calculating the factorial of each block sample size (4!=4×3×2×1=24), the number of blocks generated from all possible orders was obtained as 24; since the number of people in each block was 4 and the estimated sample size was 60 based on the following description, by matching 13 random numbers generated by Sample Randomizer with the mentioned block numbers, the order of 60 research subjects was determined, numbers one to sixty were allocated to the subject and control groups, and the random allocation list was edited.
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
Ethics committee of Yasuj University of Medical Sciences.
Street address
Alley.4, East Modaress Ave, Gachsaran town.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581698999
Approval date
2019-08-14, 1398/05/23
Ethics committee reference number
IR.YUMS.REC.1398.074
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity according to pain scale
Timepoint
Evaluation before the intervention and immediately after intervention
Method of measurement
Pain intensity scale
2
Description
Distress intensity according to Subjective units of Distress
Timepoint
Evaluation before the intervention and immediately after intervention
Method of measurement
Subjective Units of Distress (SUD)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The number of patients in this group is 30.Intervention: for each patient personally the route of EMDR will take place in 3-5 sessions. Before and after intervention both scales(SUD,PAIN SCALE) will filled by patients.
Category
Treatment - Other
2
Description
Control group: In first session all of questionnaires(demographic, sud and pain scale) will filled and then without any intervention questionnaires will be filled by patients again.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Naeem Abdi
Street address
Bagherhkan Ave. Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591959497
Phone
+98 74 3322 5041
Email
abdi.naeim@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Malekzadeh
Street address
Montazeri Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591959497
Phone
+98 74 3322 5041
Email
abdi.naeim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Naeem Abdi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Montazeri Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591959497
Phone
+98 74 3322 5041
Email
abdi.naeim@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Naeem Abdi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Montazeri Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591959497
Phone
+98 74 3322 5041
Email
abdi.naeim@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Naeem Abdi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Montazeri Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591959497
Phone
+98 74 3322 5041
Email
abdi.naeim@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