The effect of eye movement desensitization and reprocessing on fear of hypoglycemia in type 2 diabetic patients
Design
The study design was that subjects were divided into intervention and control groups. This study was a single-blind study. Randomization was performed using blue and red cards. One nurse in the Velayat hospital distributed red and blue cards to 72 patients who were eligible for the study, Each patient chose a card and none of the patients were aware of the card allocation to the intervention or control groups. The red card was assigned to the intervention group and the blue card to the control group.
Settings and conduct
The study was conducted in the internal ward of Qazvin Velayat hospital and 72 patients with type 2 diabetes were admitted to the hospital at the time.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
patients with type 2 diabetes; at least 25 years old; Confirmation of diabetes by a specialist; Treated with oral anti-diabetic or insulin medications
Non-inclusion criteria:
history of anxiety disorders; phobia and other mental disorders; history of seizures; history of strabismus and other visual disorders
Intervention groups
There were two intervention and control groups in this study. In the intervention group, eye movements desensitization and reprocessing were performed in two 45 minute sessions and in the control group no intervention was performed.
Main outcome variables
fear of hypoglycemia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181201041813N1
Registration date:2019-11-13, 1398/08/22
Registration timing:registered_while_recruiting
Last update:2019-11-13, 1398/08/22
Update count:0
Registration date
2019-11-13, 1398/08/22
Registrant information
Name
hamidreza salimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3527 5377
Email address
h.salimi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2020-01-19, 1398/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Eye Movement Desensitization and Reprocessing (EMDR) on fear of hypoglycemia in type 2 diabetic pathient
Public title
The Effect of Eye Movement Desensitization and Reprocessing (EMDR) on fear of hypoglycemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 25 years of age
confirming diabetes type 2 by a specialist in medicine
being treated with oral anti-diabetes medications or insulin
Exclusion criteria:
history of strabismus and other visual impairments
history of seizure
history of anxiety disorders, phobias and other psychiatric disorders,
Age
From 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
After selection of 72 patients , randomization was performed using blue and red cards. One of the nursing staff distributed the cards among the patients and each patient chose a card. Those who chose red cards entered the intervention group and those who chose blue cards entered the control group. None of the patients and the person who distributed the cards between them had any information about the cards
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants in this study were not aware of the random allocation of the groups, but the researcher was fully aware.
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 Blvd, Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Approval date
2018-12-11, 1397/09/20
Ethics committee reference number
IR.QUMS.REC.1397.230
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
fear of hypoglycemia
Timepoint
In this study, fear of hypoglycemia was measured at baseline, one month after intervention, and three months after intervention
Method of measurement
fear of hypoglycemia questioner
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, eye movements desensitization and reprocessing were performed in two separate 45-minute sessions for each patient in the Internal Ward of the velayat Hospital. In each intervention session, the intervention was performed by the researcher in several stages. Each phase consisted of 24 sweep cycles using finger gestures, each cycle being equal to one second, and the interval between patient and therapist equal to one meter during the intervention. The patient was asked to recall past hypoglycemic events while following his finger movements.
Category
Treatment - Other
2
Description
Control group: The control group received no intervention and patients were recalled to complete the questionnaire at baseline, one month after the study, and three months after the study.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Medical-Educational Hospital
Full name of responsible person
Hamidreza Salimi
Street address
Bahonar Blvd, Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
hamidrezasalimi1995@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Doctor Amir Peymani
Street address
Bahonar Blvd, Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
hamidrezasalimi1995@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Hamidreza Salimi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar Blvd, Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
hamidrezasalimi1995@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hamidreza Salimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar Blvd, Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
hamidrezasalimi1995@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hamidreza Salimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar Blvd, Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
hamidrezasalimi1995@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study data will be presented as individuals unrecognizable upon completion of the study. The intervention protocol will also be available to researchers after the paper is published.
When the data will become available and for how long
1 year after publishing the results
To whom data/document is available
University of Medical Sciences
Under which criteria data/document could be used
The data will be provided when the researcher arrives with the necessary equipment from medical universities.These include plans approved by medical science universities that have received a code of ethics And researchers will be allowed any statistical analysis.
From where data/document is obtainable
Qazvin University of Medical Sciences
What processes are involved for a request to access data/document
The researcher should apply by submitting a letter from the relevant medical university.