A Comparative Study of the Effect of Video Education and Guided Imagery on the Anxiety in patients before endoscopy
Design
Clinical trials involving control, video education and guided imagery, parallel-group, double-blind, 102 patients were selected and allocated for each permutation blocks grouped together.
Settings and conduct
The study is done in the endoscopic unit of Vasei Hospital in Sabzevar.After participation in the study, patients will be asked to attend one day before endoscopy in hospital and After completing the Spielberger anxiety questionnaire and demographic information, interventions are performed.
Repeating on the day of endoscopy, the Spielberger anxiety questionnaire is completed by patients before the procedure and the results are analyzed.
Participants/Inclusion and exclusion criteria
Not having a previous experience of endoscopy;Not having the necessary training before endoscopy;Non-emergency patient's condition for endoscopy
Intervention groups
A video education group that receives a education clip on how to handle the procedure, preparation and patient cooperation one day before endoscopy.
Guided imagery group to a guided imagery CD contains statements with headphones relaxing and beautiful scenery imagine a day before endoscopy and endoscopy day before the procedure listen.
Control group that receives routine care.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180226038867N1
Registration date:2018-03-17, 1396/12/26
Registration timing:prospective
Last update:2018-03-17, 1396/12/26
Update count:0
Registration date
2018-03-17, 1396/12/26
Registrant information
Name
Azam Shamekhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 5097
Email address
shamekhiA95@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of the Effect of Video Education and Guided Imagery on the Anxiety in patients before endoscopy
Public title
The Effect of Video Education and Guided Imagery on the Endoscopy Anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age:18 to 60 years old
Have complete satisfaction to participate in research
Have at least reading and writing skills
Not having previous history of endoscopy
Not having a severe illness such as cancer and chronic heart, lung, kidney disease
Not having known mental illness and anxiety disorders
Lack of Emergency Conditions for Endoscopy
No history of drug addiction and alcohol
Resident in the city of Sabzevar
Not having bad memories from the sea
Absence of disturbance in concentration and imagination
Not having vision and hearing impairment
Exclusion criteria:
Unwillingness to continue to participate in research
Emergency conditions for the patient such as bleeding and tear
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Patient selection method is randomized block permutations and will be assigned to three groups of control (34), one test (34) and two (34) test.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants - Clinical carers
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Asad Abadi Avenue, Central Organization of Sabzevar University of Medical Science
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618834733
Approval date
2018-03-10, 1396/12/19
Ethics committee reference number
IR.MEDSAB.REC.1396.177
Health conditions studied
1
Description of health condition studied
Patients undergoing endoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety based on the score obtained from the Spielberger questionnaire
Timepoint
One day before the endoscopy and endoscopy day before the procedure
Method of measurement
State-Trait Anxiety Inventory Spielberger
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Video education group,A day before the trial, they will see a 10-minute educational clip with a laptop
Category
Prevention
2
Description
Intervention group: The guided imagery group listens to the headphones one day before the procedure and day of the procedure to a 20-minute CD of guided imagery.
Category
Prevention
3
Description
Control group: Receive routine care without any special intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei Hospital
Full name of responsible person
Shamekhi Azam
Street address
Tohidshahr Blvd.,Vasei Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618834733
Phone
+98 51 4465 5097
Email
shamekhiA95@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Street address
Asadabadi street, the Central University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618834733
Phone
+98 51 4465 5097
Email
ShamekhiA95@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Azam Shamekhi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
5,Farhanghan, Farhanghan Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618834733
Phone
+98 51 4465 5097
Fax
Email
shamekhiA95@medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Azam Shamekhi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
5,Farhanghan, Farhanghan Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618834733
Phone
+98 51 4465 5097
Fax
Email
shamekhiA95@medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Azam Shamekhi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
5,Farhanghan, Farhanghan Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618834733
Phone
+98 51 4465 5097
Fax
Email
shamekhiA95@medsab.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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