Protocol summary
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Study aim
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Effectiveness of eye movement desensitization and reprocessing (EMDR) on pain intensity in cancer patients
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Design
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Trial has a control and an intervention group with parallel group and unblinded
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention: for each patient personally the route of EMDR will take place in 7 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.
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Main outcome variables
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Pain intensity; Distress intensity
General information
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Reason for update
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Recorrect the title of study and minimum of patients age as a inclusion critria
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190822044581N1
Registration date:
2019-09-21, 1398/06/30
Registration timing:
prospective
Last update:
2020-02-08, 1398/11/19
Update count:
2
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Registration date
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2019-09-21, 1398/06/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-09-23, 1398/07/01
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Expected recruitment end date
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2019-11-22, 1398/09/01
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Actual recruitment start date
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2019-09-23, 1398/07/01
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Actual recruitment end date
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2019-12-06, 1398/09/15
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Trial completion date
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2020-02-04, 1398/11/15
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Scientific title
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The effect of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients: a randomized controlled trial within a 2-month follow-up.
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Public title
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The effect of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients: a randomized controlled trial within a 2-month follow-up
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
Age of patients is between 30-60
Exclusion criteria:
Do not collaborate during the intervention
Do not tolerate the route of EMDR
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Age
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From 30 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-08-14, 1398/05/23
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Ethics committee reference number
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IR.YUMS.REC.1398.074
Health conditions studied
1
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Description of health condition studied
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Investigation the pain severity in patients with cancer
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Pain intensity according to pain scale
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Timepoint
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Evaluation before the intervention and immediately after intervention and follow-up two months after the end of the intervention
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Method of measurement
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Pain intensity scale
2
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Description
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Distress intensity according to Subjective units of Distress
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Timepoint
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Evaluation before the intervention and immediately after intervention and follow-up two months after the end of the intervention
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Method of measurement
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Subjective Units of Distress (SUD)
Intervention groups
1
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Description
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Intervention group:The number of patients in this group is 30.Intervention: for each patient personally the route of EMDR took place in 7 sessions. Before and after intervention both scales(SUD,PAIN SCALE) were filled by patients. After two months of follow-up, the above measures will be completed by the patients again
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Category
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Treatment - Other
2
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Description
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Control group: In first session all of questionnaires(demographic, sud and pain scale) filled and then without any intervention questionnaires were filled by patients again. The control group received no intervention from the beginning of the intervention until the end of the follow-up and received only routine care. In the first session, the demographic characteristics questionnaire, pain rating scale and mental distress scale will be completed in the first session, then the questionnaires will be completed two months later without any intervention.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yasouj University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available