1. Home
  2. Approved trials
  3. » فارسی

The effect of Virtual Reality distraction on pain and anxiety during dental Treatment in children

Protocol summary

Study aim
Determining the effect of Virtual Reality distraction on pain and anxiety during dental treatment in children
Design
Clinical trial with control group, no blinded, randomized , on 30 patients
Settings and conduct
We will examine 30 children aged 4 to 12 years referring to dental offices and clinics affiliated to Shahrekord University of Medical Sciences. These children will be randomly divided into two control and experimental groups, and a one-session pulpotomy will be considered for them. In the control group, the Tell-Show-Do behavioral guidance method will be used. In the study group, a virtual reality headset with the ability to play cartoons and movies in 3D will be used to distract the child. Finally, in both groups, the level of pain will be recorded and compared through the Wong-Baker Faces pain scale and the level of anxiety through the MCDAS scale (f) and using a pulse oximetry device and the effectiveness of using virtual reality. , will be measured.
Participants/Inclusion and exclusion criteria
Inclusion: Good cooperation, child and parent satisfaction, and the child's physical and mental is healthy Exclusion: children who were not sensitive to flash light or had not accidents in the eyes, face, and neck
Intervention groups
In the control group, the Tell-Show-Do behavioral guidance method will be used. it means that every dental procedure that is going to be performed for a child, the child should be well informed about it. In the studied group, a virtual reality headset is used, which will play the movie from the screen of the phone.
Main outcome variables
Pain score;Anxiety score;The level of dissolved oxygen in the blood heart rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230704058670N1
Registration date: 2023-11-17, 1402/08/26
Registration timing: prospective

Last update: 2023-11-17, 1402/08/26
Update count: 0
Registration date
2023-11-17, 1402/08/26
Registrant information
Name
Sajedeh Saberi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 910 392 6170
Email address
saberisajede78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Virtual Reality distraction on pain and anxiety during dental Treatment in children
Public title
The effect of Virtual Reality on pain and anxiety during dental treatment in children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Children with Frankl's behavior 3 and 4 Children who are free from any psychological as well as systemic illness Children without any anxiety disorders
Exclusion criteria:
Children whose parents were not willing to give consent to the study sensitivity to the motion or flash light or having accidents in the eyes, face, neck, or arms
Age
From 4 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign patients, the permutation block method will be used with a volume of 6. For this purpose, 5 blocks with a volume of 6 will be prepared by the RA software and will be available to the researchers. Each block will include 6 patients who will be divided into 2 intervention and control groups by one of the following modes: A: control group B: intervention group AAABBB, AABABB,ABABAB,BBBAAA,...
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 Shahrekord University of Medical Sciences, Shahrekord, Iran
Street address
Yeganeh St., 105 Alley, Sub 9, No. 27
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814874595
Approval date
2023-10-09, 1402/07/17
Ethics committee reference number
IR.SKUMS.MED.REC.1402.053

Health conditions studied

1

Description of health condition studied
Investigating distraction through virtual reality
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety score on the scale Faces version of the Modified Child Dental Anxiety Scale
Timepoint
Before and after the intervention
Method of measurement
Questionnaire of Faces version of the Modified Child Dental Anxiety Scale

2

Description
Wong-Baker Faces pain scale
Timepoint
After the intervention
Method of measurement
Questionnaire of Wong-Baker faces pain scale

Secondary outcomes

1

Description
The level of dissolved oxygen in the blood
Timepoint
Before the intervention and after the intervention
Method of measurement
Pulse oximetry device

2

Description
heart rate
Timepoint
Before the intervention and after the intervention
Method of measurement
Pulse oximetry device

Intervention groups

1

Description
Intervention group: In the studied group, a virtual reality headset is used, which will play the movie from the screen of the phone. The children of the study group were asked to watch the film for 5 minutes before starting the dental treatment and after a little rest, watch the continuation of the film during the dental treatment. After the completion of the treatment, the headset will be removed. Clinical examination and radiographic evaluation will be performed for these children, and the milk molar teeth that require a single-session pulpotomy in the upper and lower jaws will be determined. Teeth with deep caries but Without symptoms, those who do not have swelling, abscess and fistula related to teeth, as well as laxity and movement in clinical examinations, are selected. Also, no periapical radiolucency should be seen in the radiograph. In pulpotomy, when the coronal pulp is removed, the bleeding should be easy to control and the bleeding should stop within 5 minutes after using a pressure pack.
Category
Treatment - Devices

2

Description
Control group: In the control group, the traditional TSD behavioral guidance method will be used. The TSD method is one of the most common methods of behavioral management techniques, and it means that every dental procedure that is going to be performed on a child, the child must be well informed about it, so a demonstration is given to him using a simulator can be.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Personal office in shahrekord
Full name of responsible person
Doctor Fatemeh Naderi
Street address
Yeganeh St., 105 Alley, Sub 9, No. 27
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814874595
Phone
+98 910 392 6170
Email
Saberisajede78@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Doctor Elham Raesi
Street address
Yeganeh St., 105 Alley, Sub 9, No. 27
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814874595
Phone
+98 910 392 6170
Email
Saberisajede78@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Sajedeh-Saberi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Yeganeh St., 105 Alley, Sub 9, No. 27
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814874595
Phone
+98 910 392 6170
Email
saberisajede78@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Sajedeh-Saberi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Yeganeh St., 105 Alley, Sub 9, No. 27
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814874595
Phone
+98 910 392 6170
Email
saberisajede78@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Sajedeh-Saberi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Yeganeh St., 105 Alley, Sub 9, No. 27
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814874595
Phone
+98 910 392 6170
Email
saberisajede78@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The clinical study report will be reported as an article.
When the data will become available and for how long
The access period starts immediately after the results are printed
To whom data/document is available
Access is open to the public
Under which criteria data/document could be used
For more information
From where data/document is obtainable
Yeganeh St., 105 Alley, Sub 9, No. 27 Saberi-Sajedeh 09103926170 saberisajede@gmail.com
What processes are involved for a request to access data/document
The clinical study report will be made available to the public immediately after publication. For more information, send an email to saberisajede78@gmail.com.
Comments
Loading...