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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General information
15
30
1530
2019-11-11, 1398/08/20
2019-12-06, 1398/09/15
2019-1112-1106 00:00:00
2020-01-10, 1398/10/20
2020-02-04, 1398/11/15
2020-0102-1004 00:00:00
End of intervention. Begin Two-month follow-up of the samples after the intervention.
Recorrect the title of study and minimum of patients age as a inclusion critria
EndRecorrect the title of intervention. Begin Two-month follow-upstudy and minimum of the samples after the intervention.patients age as a inclusion critria
پایان مداخله.پیگیری دو ماهه نمونه ها بعد از انجام مداخله
اصلاح مجدد عنوان مطالعه و حداقل سن بیماران به عنوان معیار ورود
پایان مداخله.پیگیری دو ماهه نمونه ها بعد از انجام مداخلهاصلاح مجدد عنوان مطالعه و حداقل سن بیماران به عنوان معیار ورود
Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients: Two 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
EffectivenessThe effect of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients: Two a randomized controlled trial within a 2-month follow-up
بررسی تاثیر روش حساسیت زدایی با حرکات چشم و پردازش مجدد بر شدت درد بیماران مبتلا به سرطان: پیگیری دو ماهه
بررسی تاثیر روش حساسیت زدایی با حرکات چشم و پردازش مجدد بر شدت درد بیماران مبتلا به سرطان: یک مطالعه کارآزمایی تصادفی کنترل شده با ۲ ماه پیگیری
بررسی تاثیر روش حساسیت زدایی با حرکات چشم و پردازش مجدد بر شدت درد بیماران مبتلا به سرطان: یک مطالعه کارآزمایی تصادفی کنترل شده با ۲ ماه پیگیری دو ماهه
Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients: Two 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.
EffectivenessThe effect of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients: Two a randomized controlled trial within a 2-month follow-up.
بررسی تاثیر روش حساسیت زدایی با حرکات چشم و پردازش مجدد بر شدت درد بیماران مبتلا به سرطان: پیگیری دو ماهه
بررسی تاثیر روش حساسیت زدایی با حرکات چشم و پردازش مجدد بر شدت درد بیماران مبتلا به سرطان: یک مطالعه کارآزمایی تصادفی کنترل شده با پیگیری دو ماهه
بررسی تاثیر روش حساسیت زدایی با حرکات چشم و پردازش مجدد بر شدت درد بیماران مبتلا به سرطان: یک مطالعه کارآزمایی تصادفی کنترل شده با پیگیری دو ماهه
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
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
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
- ابتلا به بیماری سرطان طبق تشخیص پزشک متخصص که حداقل 6 ماه از آن گذشته باشد.
پایداری وضعیت همودینامیک بیمار
عدم استفاده از آرام بخش ها
درد متوسط تا شدید ناشی از سرطان بر اساس مقیاس درد
هوشیاری و آموزش پذیر بودن بیمار
سواد خواندن و نوشتن
عدم وجود اختلالات بینایی و استرابیسم
عدم سابقه مصرف مواد مخدر
نداشتن بیماری های سیستمیک که سیستم عصبی را تحت تأثیر قرار می دهند
- ابتلا به بیماری سرطان طبق تشخیص پزشک متخصص که حداقل 6 ماه از آن گذشته باشد.
پایداری وضعیت همودینامیک بیمار
عدم استفاده از آرام بخش ها
درد متوسط تا شدید ناشی از سرطان بر اساس مقیاس درد
هوشیاری و آموزش پذیر بودن بیمار
سواد خواندن و نوشتن
عدم وجود اختلالات بینایی و استرابیسم
عدم سابقه مصرف مواد مخدر
نداشتن بیماری های سیستمیک که سیستم عصبی را تحت تأثیر قرار می دهند
سن بیماران بین ۳۰ تا ۶۰ باشد
- ابتلا به بیماری سرطان طبق تشخیص پزشک متخصص که حداقل 6 ماه از آن گذشته باشد. پایداری وضعیت همودینامیک بیمار عدم استفاده از آرام بخش ها درد متوسط تا شدید ناشی از سرطان بر اساس مقیاس درد هوشیاری و آموزش پذیر بودن بیمار سواد خواندن و نوشتن عدم وجود اختلالات بینایی و استرابیسم عدم سابقه مصرف مواد مخدر نداشتن بیماری های سیستمیک که سیستم عصبی را تحت تأثیر قرار می دهند سن بیماران بین ۳۰ تا ۶۰ باشد
Health conditions studied
#1
Cancer
Investigation the pain severity in patients with cancer
CancerInvestigation the pain severity in patients with cancer
سرطان
بررسی شدت درد بیماران مبتلا به سرطان
بررسی شدت درد بیماران مبتلا به سرطان
Protocol summary
Study aim
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.
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 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.
Main outcome variables
Pain intensity; Distress intensity
General information
Reason for update
Recorrect the title of study and minimum of patients age as a inclusion critria
Acronym
IRCT registration information
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
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
2019-09-23, 1398/07/01
Actual recruitment end date
2019-12-06, 1398/09/15
Trial completion date
2020-02-04, 1398/11/15
Scientific title
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.
Public title
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
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
Age of patients is between 30-60
Exclusion criteria:
Do not collaborate during the intervention
Do not tolerate the route of EMDR
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
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
Investigation the pain severity in patients with 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 and follow-up two months after the end of the 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 and follow-up two months after the end of the 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 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
Category
Treatment - Other
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Jalil hospital of Yasuj city
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