The present study will be aimed to investigate the effects of virtual reality technology on pre-operative anxiety in children. As an experimental study, it has a control group with pretests and posttests. Moreover, the statistical population will comprised of all children candidate for surgeries at Dr Mohammad Kermanshahi Hospital in Kermanshah, Iran. Of the whole statistical population, 20 children will selected through the convenience sampling and randomly assigned to two groups (10 in the experimental group and 10 in the control one). Not to mention, the inclusion criteria will be the pre-operative anxiety. The examinees will give the pre-tests, and then the participants in the experimental group will provide with virtual reality. In other words, their eyes will equipped with glasses with a broad field of vision while watching the simulated process of entering the operating room. in control group we will use of intimacy and companion of parents for subjects. In addition, the examinees will given the anxiety questionnaires about two or three hours prior to going into the operating room. Furthermore, the findings in both groups will be compared with each other in the pre and post-test stages. One of the primary outcomes of this therapeutic method is the reduction of the pre-operative anxiety in children.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021525433N3
Registration date:2017-04-28, 1396/02/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-28, 1396/02/08
Registrant information
Name
Fatemeh Dehghan
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3432 1439
Email address
srghasemi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual reality technology on Preoperative anxiety in children
Public title
The effect of virtual reality technology on Preoperative anxiety in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:age range of between 8 and 12 years, candidate for abdominal surgery, no history of abdominal surgery, no mental illness through patient's file or asking from patient's companion.
Exclusion criteria: stress or particular problems when using the glasses and virtual reality handset. previous history of using virtual reality instrument.
Age
From 7 years old to 16 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In the present study we will use closed pocket for random assignment. By asking patients to chose a sheet and then will be assigned to experimental or control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor of Research,No 2 Building , Kermanshah University of Medical Sciences,Martyr Shahid Beheshti, Kermanshahi
City
Kermanshah
Postal code
Approval date
2017-02-14, 1395/11/26
Ethics committee reference number
KUMS.REC.1395.659
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
f41
ICD-10 code description
anxiety disorders, nonorganic or unspecified
Primary outcomes
1
Description
anxiety
Timepoint
Before surgery
Method of measurement
Beak Anxiety Questionnaire
Secondary outcomes
1
Description
Relaxation
Timepoint
Before surgery
Method of measurement
Questionnaire
Intervention groups
1
Description
Control group: Caress
Category
Behavior
2
Description
Intervention group: Virtual reality technology
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Mohammad Kermanshahi Hospital
Full name of responsible person
Rostam Jalali
Street address
Hilal Ahmar crossroads, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Kermanshah University of Medical Sciences
Full name of responsible person
Korosh Hamzai
Street address
Vice President of Research, Building 2, Kermanshah University of Medical Sciences,Martyr Shahed Behesht, Kermanshahi
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Position
Research Assistant
Other areas of specialty/work
Street address
Vice Chancellor of Research, Building 2, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah,
City
Kermanshah
Postal code
Phone
+98 83 3432 1439
Fax
Email
fateme.dehghan1368@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Rostam Jalali
Position
PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Dolatabad, Kermanshah