History
# Registration date Revision Id
3 2020-02-04, 1398/11/15 121007
2 2020-01-17, 1398/10/27 118558
1 2019-09-21, 1398/06/30 104435
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  • Protocol summary

    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.
    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.
    تجسم بصری یک تصویر(برجسته ترین بخش) از صحنه آسیب زا مربوط به درد ناشی از سرطان. پی گیری بصری حرکت انگشت مداخله گر در همان حالتی که بیمار صحنه آسیب زا را پی در پی مجسم می کند. بیمار باید حرکات سریع انگشت مداخله گر را که در عرض میدان بینایی وی قرار دارد با حرکات سریع چشم دنبال کند. انگشت مداخله گر تقریباً 30 سانتی متر از چشمان بیمار فاصله داشته و از راست به چپ وبلعکس در میدان بینایی بیمار حرکت می کند. این حرکت شامل دوبار رفت و برگشت به طرفین در عرض یک ثانیه که یک چرخه محسوب می شود و هر 24-12 چرخه یک مجموعه است. این مجموعه بر اساس نیاز بیمار و همکاری او می تواند تا 5 جلسه و هر جلسه 30تا 45 دقیقه انجام شود (شاپیرو2010).بعد از پایان هر جلسه پرسشنامه ها توسط بیمار مجددا تکمیل می شوند.
    تجسم بصری یک تصویر(برجسته ترین بخش) از صحنه آسیب زا مربوط به درد ناشی از سرطان. پی گیری بصری حرکت انگشت مداخله گر در همان حالتی که بیمار صحنه آسیب زا را پی در پی مجسم می کند. بیمار باید حرکات سریع انگشت مداخله گر را که در عرض میدان بینایی وی قرار دارد با حرکات سریع چشم دنبال کند. انگشت مداخله گر تقریباً 30 سانتی متر از چشمان بیمار فاصله داشته و از راست به چپ وبلعکس در میدان بینایی بیمار حرکت می کند. این حرکت شامل دوبار رفت و برگشت به طرفین در عرض یک ثانیه که یک چرخه محسوب می شود و هر 24-12 چرخه یک مجموعه است. (شاپیرو2010).بعد از پایان هر جلسه پرسشنامه ها توسط بیمار مجددا تکمیل می شوند.
    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.
    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.
    گروه مداخله:روش درمانی EMDR برای هر بیمار به صورت انفرادی در اتاق مشاوره سه تا پنج جلسه یک ساعته(بر اساس شرایط بیمار) انجام خواهد شد. در هر جلسه قبل از مداخله و بعد از مداخله دو مقیاس ناراحتی ذهنی و مقیاس رتبه بندی درد مجددا توسط بیماران تکمیل می شود. تعدادبیماران در این گروه 30 نفر می باشد. گروه کنترل در جلسه اول پرسشنامه ویژگی های جمعیت شناختی ، مقیاس رتبه بندی درد و مقیاس ناراحتی ذهنی تکمیل شده، سپس بعد از پایان هر جلسه بدون هیچ گونه مداخله ای دوباره پرسشنامه های فوق توسط واحدهای مورد پژوهش تکمیل خواهد شد.تعدادبیماران در این گروه 30 نفر می باشد.
    گروه مداخله:روش درمانی EMDR برای هر بیمار به صورت انفرادی در اتاق مشاوره 7 جلسه یک ساعته(بر اساس شرایط بیمار) انجام خواهد شد. در هر جلسه قبل از مداخله و بعد از مداخله دو مقیاس ناراحتی ذهنی و مقیاس رتبه بندی درد مجددا توسط بیماران تکمیل می شود. تعدادبیماران در این گروه 30 نفر می باشد. گروه کنترل در جلسه اول پرسشنامه ویژگی های جمعیت شناختی ، مقیاس رتبه بندی درد و مقیاس ناراحتی ذهنی تکمیل شده، سپس بعد از پایان هر جلسه بدون هیچ گونه مداخله ای دوباره پرسشنامه های فوق توسط واحدهای مورد پژوهش تکمیل خواهد شد.تعدادبیماران در این گروه 30 نفر می باشد.
  • General information

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    60
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    2019-09-23, 1398/07/01
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    2019-11-11, 1398/08/20
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    2020-01-10, 1398/10/20
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    End of intervention. Begin Two-month follow-up of the samples after the intervention.
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    پایان مداخله.پیگیری دو ماهه نمونه ها بعد از انجام مداخله
    Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients
    Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients: Two month follow up
    بررسی اثربخشی حساسیت زدایی با حرکات چشم و پردازش مجدد بر شدت درد بیماران مبتلا به سرطان
    بررسی تاثیر روش حساسیت زدایی با حرکات چشم و پردازش مجدد بر شدت درد بیماران مبتلا به سرطان: پیگیری دو ماهه
    Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients
    Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients: Two month follow up
    بررسی اثربخشی حساسیت زدایی با حرکات چشم و پردازش مجدد بر شدت درد بیماران مبتلا به سرطان
    بررسی تاثیر روش حساسیت زدایی با حرکات چشم و پردازش مجدد بر شدت درد بیماران مبتلا به سرطان: پیگیری دو ماهه
  • Primary outcomes

    #1
    Evaluation before the intervention and immediately after intervention
    Evaluation before the intervention and immediately after intervention and follow-up two months after the end of the intervention
    سنجش قبل از مداخله و اندازه گیری بلافاصله بعد از مداخله
    سنجش قبل از مداخله و اندازه گیری بلافاصله بعد از مداخله و پیگیری دو ماهه بعد از پایان مداخله
    #2
    Evaluation before the intervention and immediately after intervention
    Evaluation before the intervention and immediately after intervention and follow-up two months after the end of the intervention
    سنجش قبل از مداخله و اندازه گیری بلافاصله بعد از مداخله
    سنجش قبل از مداخله و اندازه گیری بلافاصله بعد از مداخله و پیگیری دو ماهه بعد از پایان مداخله
  • Intervention groups

    #1
    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.
    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
    گروه مداخله:تعداد بیماران این گروه 30 نفر می باشد. روش درمانی EMDR برای هر بیمار به صورت انفرادی در اتاق مشاوره سه تا پنج جلسه یک ساعته(بر اساس شرایط بیمار) انجام خواهد شد. در هر جلسه قبل از مداخله و بعد از مداخله دو مقیاس ناراحتی ذهنی و مقیاس رتبه بندی درد مجددا توسط بیماران تکمیل می شود.ف
    گروه مداخله:تعداد بیماران این گروه 30 نفر می باشد. روش درمانی EMDR برای هر بیمار به صورت انفرادی در اتاق مشاوره 7جلسه یک ساعته(بر اساس شرایط بیمار) انجام شد. در هر جلسه قبل از مداخله و بعد از مداخله دو مقیاس ناراحتی ذهنی و مقیاس رتبه بندی درد مجددا توسط بیماران تکمیل شد.بعد از دو ماه پیگیری مجددا مقیاس های فوق توسط بیماران تکمیل خواهد شد
    #2
    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.
    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.
    گروه کنترل: گروه کنترل در جلسه اول پرسشنامه ویژگی های جمعیت شناختی ، مقیاس رتبه بندی درد و مقیاس ناراحتی ذهنی تکمیل شده، سپس بعد از پایان هر جلسه بدون هیچ گونه مداخله ای دوباره پرسشنامه های فوق توسط واحدهای مورد پژوهش تکمیل خواهد شد.
    گروه کنترل: گروه کنترل در جلسه اول پرسشنامه ویژگی های جمعیت شناختی ، مقیاس رتبه بندی درد و مقیاس ناراحتی ذهنی تکمیل شد سپس بعد از پایان هر جلسه بدون هیچ گونه مداخله ای دوباره پرسشنامه های فوق توسط واحدهای مورد پژوهش تکمیل شد.در گروه کنترل از شروع مداخله تا پایان پیگیری هیچ مداخله ای از طرف محقق صورت نگرفت و فقط مراقبت های روتین را دریافت نمودند. در این گروه در جلسه اول پرسشنامه ویژگی های جمعیت شناختی، مقیاس رتبه بندی درد و مقیاس ناراحتی ذهنی تکمیل شده، سپس دو ماه بعد بدون هیچ گونه مداخله ای دوباره پرسشنامه های فوق توسط واحدهای مورد پژوهش تکمیل خواهد شد..
  • Recruitment centers

    #1
    Name of recruitment center - English: Shahid Beheshti hospital
    Name of recruitment center - Persian: بیمارستان شهیدبهشتی
    Full name of responsible person - English: Naeem Abdi
    Full name of responsible person - Persian: نعیم عبدی
    Street address - English: Bagherhkan Ave. Yasuj
    Street address - Persian: خیابان باقرخان
    City - English: Yasuj
    City - Persian: یاسوج
    Province: Kohgilouyeh-va-Boyrahmad
    Country: Iran (Islamic Republic of)
    Postal code: 7591959497
    Phone: +98 74 3322 5041
    Fax:
    Email: abdi.naeim@yahoo.com
    Web page address:
    Name of recruitment center - English: Shahid Jalil hospital of Yasuj city
    Name of recruitment center - Persian: بیمارستان شهید جلیل یاسوج
    Full name of responsible person - English: Naeem Abdi
    Full name of responsible person - Persian: نعیم عبدی
    Street address - English: Bagherhkan Ave. Yasuj
    Street address - Persian: خیابان باقرخان
    City - English: Yasuj
    City - Persian: یاسوج
    Province: Kohgilouyeh-va-Boyrahmad
    Country: Iran (Islamic Republic of)
    Postal code: 7591959497
    Phone: +98 74 3322 5041
    Fax:
    Email: abdi.naeim@yahoo.com
    Web page address:

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
End of intervention. Begin Two-month follow-up of the samples after the intervention.
Acronym
IRCT registration information
IRCT registration number: IRCT20190822044581N1
Registration date: 2019-09-21, 1398/06/30
Registration timing: prospective

Last update: 2020-01-19, 1398/10/29
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
2019-11-11, 1398/08/20
Trial completion date
2020-01-10, 1398/10/20
Scientific title
Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients: Two month follow up
Public title
Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) on pain intensity in cancer patients: Two 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
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
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
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
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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