Determination of the effect of sensitization with eye movements and re-processing on death anxiety in patients with gastroesophageal cancer in Qazvin province hospital in 1397
Design
Clinical practice with two groups of intervention and control, randomized
Settings and conduct
In intervention group, Eye Movement Desensitization and Reprocessing treatment method was done individually conduct for each patient in the consultation room 90 minutes, within 5 sessions over a month.
Participants/Inclusion and exclusion criteria
Intolerance to anxiety and reluctance to continue participating in the study;
The desire to participate in this study؛
Diagnosis of cancer by a specialist؛
Non-cardiovascular disease؛
Ability to collaborate and answer questions؛
Intervention groups
Patients are divided into two groups of intervention and control. An intervention group and a control group.
In the intervention group, sensitization was performed with eye movement and re-processing.The control group did not receive any intervention and only the questionnaire was redistributed on time and data were collected.
Main outcome variables
death anxiety ; Eye movement desensitization and reprossesing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190613043885N1
Registration date:2019-11-23, 1398/09/02
Registration timing:retrospective
Last update:2019-11-23, 1398/09/02
Update count:0
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Najime Fotovat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3451 9369
Email address
n.fotovat@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
2019-03-21, 1398/01/01
Actual recruitment end date
2019-07-22, 1398/04/31
Trial completion date
2019-07-22, 1398/04/31
Scientific title
Effect of Eye Movement Desensitization and Reprocessing ( EMDR) on death anxiety in patients with gastrointestinal cancer
Public title
Effect of Eye Movement Desensitization and Reprocessing ( EMDR) on death anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in this study
Not having other psychological problems
People have not participated in any training course to relieve anxiety
Being aware of the cancer
Ability to cooperate and answer questions
Diagnosis of cancer by a specialist
Not Strabismus
Non-Cardiovascular disease
Exclusion criteria:
Cancer of other organs of the body
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Actual sample size reached:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized
The randomization algorithm is performed using Smith's method. By using randomized blocks method (four blocks of letters A and B), eligible samples are assigned to two intervention groups.The randomization tool consists of some cards which have a combinations of two letters A and two letters B. These combinations are then randomly selected each time to determine how the four samples are placed in each group.
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 Qazvin University of Medical Sciences
Street address
Bahonar Street, Golestan Residence, University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2018-12-30, 1397/10/09
Ethics committee reference number
IR.QUMS.REC.1397.259
Health conditions studied
1
Description of health condition studied
death anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
death anxiety
Timepoint
Measurement of anxiety death before intervention and immediately after intervention
Method of measurement
Templer death anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sensitization with eye movements and re-processing. The method of doing this study is to move the fingers and retrieve the memory of the annoying events simultaneously and to replace the pleasant memories with the annoying ones. In this way, the patient is asked to follow the intervening finger movements while contemplating the disturbing events, and in the next step the patient is asked to close his or her mind and think of a positive memory and take a few deep breaths.
Category
Treatment - Other
2
Description
Control group:In the control group, no intervention will be performed and the subjects will complete the questionnaires on time.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Dr. Ali Akbar Karami
Street address
Ghazvin Bahonar Street Golestan Dormitory
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
N.fotovat@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Mohammad Sheikhi
Street address
Qazvin, Golestan Residence, Bahonar Street
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
najme.ftv@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Najime Fotovat
Position
student of university
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin, Golestan Residence, Bahonar Street
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 982833336001
Email
najme.ftv@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Najime Fotovat
Position
student of university
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin Bahonar Street
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
najme.ftv@gmail.com
Web page address
http://hosqods.qums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
najime fotovat
Position
student of university
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghazvin Bahonar Street Golestan Dormitory
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
najme.ftv@gmail.com
Web page address
http://www.qums.ac.ir/
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available