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IRCT20190822044581N1 IRCT 2019-09-21 Yasouj University of Medical Sciences 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 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. 2019-09-23 anticipated 60 Complete https://irct.ir/trial/41651 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. N/A Investigation the pain severity in patients with cancer. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There are not more details.
public Naeem Abdi
Montazeri Street, Yasuj
Yasuj Iran (Islamic Republic of) 7591959497 +98 74 3322 5041 abdi.naeim@yahoo.com Yasouj University of Medical Sciences scientific Naeem Abdi
Montazeri Street, Yasuj
Yasuj Iran (Islamic Republic of) 7591959497 +98 74 3322 5041 abdi.naeim@yahoo.com Yasouj University of Medical Sciences Iran (Islamic Republic of) 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 30 years 60 years Both Do not collaborate during the intervention Do not tolerate the route of EMDR Treatment - Other Treatment - Drugs 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 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. Pain intensity according to pain scale. Timepoint: Evaluation before the intervention and immediately after intervention and follow-up two months after the end of the intervention. Method of measurement: Pain intensity scale. Distress intensity according to Subjective units of Distress. Timepoint: Evaluation before the intervention and immediately after intervention and follow-up two months after the end of the intervention. Method of measurement: Subjective Units of Distress (SUD). Yasouj University of Medical Sciences Approved 2019-08-14 Ethics committee of Yasuj University of Medical Sciences. Alley.4, East Modaress Ave, Gachsaran town. Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)