Protocol summary

Study aim
to assess the effect of distraction by using a virtual reality (VR) headset on pain perception and anxiety of pediatric dental patients
Design
A single-blind randomized cross-over clinical trial was designed on in which one group received the dental procedure under distraction by a VR headset while the other group received the procedure with no distraction. The sample consisted of 40 patients referred to the pediatric ward of Shahid Beheshti Dental School
Settings and conduct
The patients were randomly assigned to 2 groups (n=20). both groups received fluoride therapy in the first treatment session. In the second session, one group received the dental procedure under distraction with a VR headset while the other group served as control and received treatment with no distraction. This order was reversed in the third treatment session for treatment of the other quadrant of patients. Heart rate (HR), as an indicator of the anxiety level, was measured by a pulse oximeter, and pain level was quantified using the Wong-Baker Faces pain rating scale (WBFPS) preoperatively, after injection, and after termination of the procedure
Participants/Inclusion and exclusion criteria
The inclusion criteria were (I) age between 5-7 years, (II) requiring bilateral pulpotomy and subsequent placement of stainless-steel crowns for at least two mandibular teeth, and (III) willingness of the children and parents to use a VR headset. The exclusion criterion was having an anxiety disorder with a Screen for Child Anxiety Related Disorders (SCARED) score > 25.
Intervention groups
Use or non-use of virtual reality glasses in children during dental treatment
Main outcome variables
Pain and HR (indicative of anxiety level) were the primary outcomes.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210908052413N1
Registration date: 2024-11-18, 1403/08/28
Registration timing: retrospective

Last update: 2024-11-18, 1403/08/28
Update count: 0
Registration date
2024-11-18, 1403/08/28
Registrant information
Name
Kiana Poorzandpoush
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2242 4428
Email address
kianapoorzand@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Distracting Patients using Virtual Reality Glasses on the Perception of Pain and Anxiety in Children during Dental Treatment
Public title
"Effect of virtual reality glasses in pediatric dental treatment"
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
children aging 5 to 7 years old were selected who underwent bilateral pulpotomy with stainless SSC crown treatments
Exclusion criteria:
Children with previous anxiety disorder
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 40
More than 1 sample in each individual
Number of samples in each individual: 2
In cross over clinical trial method treatment will performe for each individual using virtual reality glasses and also without using virtual reality glasses and the studied variables will measure and analyze in both sessions.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the data analyst, the statistical consultant, will kept blind from being assigned to the study groups.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Medical Research, School of Dentistry, Shahid Beheshti University of Medical Sci
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2020-01-28, 1398/11/08
Ethics committee reference number
IR.SBMU.DRC.REC.1398.244

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F93.0
ICD-10 code description
Separation anxiety disorder of childhood

Primary outcomes

1

Description
The level of pain perceived by the child
Timepoint
Record the level of perceived pain before starting treatment, after anesthesia injection and at the end of treatment with or without the use of virtual reality glasses
Method of measurement
Wong Baker FACES Pain Rating Scale

2

Description
Measuring the level of anxiety and the level of cooperation of the child
Timepoint
Record and report the amount of movements as well as the general behavior of the child before, after the injection of anesthesia and also at the end of treatment with or without the use of virtual reality glasses
Method of measurement
Houpt Scale for Movement and General Behavior in Children

3

Description
pulse rate
Timepoint
Record and report pulse rate before starting treatment, after anesthesia injection and also at the end of treatment with or without the use of virtual reality glasses
Method of measurement
Finger pulse oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Children under pulpotomy in primary teeth to distract with virtual reality glasses during treatment in first session, The virtual reality glasses will be used by the Samsung brand 2017 model, and the children's favorite animation will be played that has already been announced. And then in the second session, for the same children, pulpotomy of primary teeth will be performed without the use of virtual reality glasses.
Category
Behavior

2

Description
Intervention group: Children under pulpotomy in primary teeth without distraction with virtual reality glasses during treatment in first session. And then in the second session, for the same children, pulpotomy of primary teeth will be performed with the use of virtual reality glasses. The virtual reality glasses will be used by the Samsung brand 2017 model, and the children's favorite animation will be played that has already been announced.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatric ward of school of dentistry, Shahid Beheshti University of Medical Siences
Full name of responsible person
Kiana Poorzandpoush
Street address
3th Floor, Bldg No.2 SBMU, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
Email
DentalSchoolInfo@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshju Blv., Velenjak St., Chamran Highway, Tehran, Iran,
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2387 2203
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
70
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kiana Poorzandpoush
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Daneshgah (Shahriari) Square, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2242 4428
Email
Kianapoorzand@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Yasaman Rezvani
Position
Faculty member,Department of pediatric dentistry, school pf dentistry, Shahid beheshti university of
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Daneshgah (Shahriari) Square, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 8827 9030
Email
yrezvani5@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Aliasghar Soleimani
Position
Assistant professor, Department of pediatric dentistry, school pf dentistry, Shahid beheshti univers
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Daneshgah (Shahriari) Square, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5351
Email
drsoleymaniali@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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The recorded data can be shared based on the studied indicators after identifying the sample individuals, These data include the numbers and scores reported from the Wong Baker FACES Pain Rating Scale, Houpt Scale, and numbers recorded from the finger pulse oximeter at specified times, as well as the results of statistical analysis of these data.
When the data will become available and for how long
e.g., starting 6 months after publication
To whom data/document is available
Researchers working in academic and scientific institutes can apply for access to the data.
Under which criteria data/document could be used
Performing statistical analyzes to compare data with other studies in this field is one of the conditions for access to data, so the analysis must be appropriate to the type of data received from the applicant.
From where data/document is obtainable
Applicants can obtain access to the data by submitting a request to the following emails in due time. Moderator: Sajjad Aghamohammadi Email address: sajadaghamohamadi@live.com WhatsApp number: 00989126671172
What processes are involved for a request to access data/document
After submitting the request by email and also sending the request to WhatsApp of the specified person, the applicant will be able to access the information within one week after submitting the request, if she has the requisite conditions.
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