Effect of Virtual Reality Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment
Primary Purpose
Dental Anxiety
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
virtual reality glasses
music
Sponsored by
About this trial
This is an interventional health services research trial for Dental Anxiety
Eligibility Criteria
Inclusion Criteria:
- Children aged 5-8 years.
- Children without any mental or systemic disorder.
- Children need extraction of primary molars under local anesthesia.
Exclusion Criteria:
- Children with visual impairment.
- Children with hearing disabilities.
- Patients or caregivers who refuse to sign the consent.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
audiovisual distraction
audiodistraction
Arm Description
Outcomes
Primary Outcome Measures
preoperative anxiety
Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter in beat per minute unit (BPM)
postoperative anxiety
using a fingertip pulse oximeter in beat per minute unit (BPM)
preoperative anxiety
RMS-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial scale) before administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
postoperative anxiety
S-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial scale) immediatly after extraction in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
Secondary Outcome Measures
subjective pain
using Visual analogue scale (vas scale) (0-10) , self reported pain as the child choose a number from 0 to 10 which describes the intensity of his or her pain.
0 =no pain 10=extreme pain.
objective pain
using FLCCS (0-10)valuated by the outcomes assessor. The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05083988
Brief Title
Effect of Virtual Reality Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment
Official Title
Effect of Virtual Reality Distraction Versus Audio Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment (A Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the study is to evaluate and compare the effect of virtual reality glasses (VR) as an audiovisual distraction method to audio distraction using music on child's dental anxiety during dental treatment.
Detailed Description
a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention group: audiovisual distraction using virtual reality glasses control group :audio distraction using music. in children aged 5-8 years who need dental extraction for primary molars.
For both groups:
Taking personal data, medical and dental history.
Diagnosis and determination of the required treatment.
Measuring preoperative anxiety (expressed by heart rate) using a pulse oximeter.
Using the behavior guidance technique:
Intervention group: The Child is introduced to the virtual reality glasses device, and was given instructions on how to use it and was allowed to choose one of previously chosen cartoons to be played during the procedure.
Control group: The child is introduced to the headphones and was given instructions on how to use it, and a relaxing music is played during the procedure.
Administration of topical anesthesia.
Administration of local anesthesia.
Check the effectiveness of local anesthesia using dental probe.
Extraction of the affected tooth.
Measuring postoperative anxiety (expressed by heart rate) using the pulse oximeter.
Evaluate the objective pain using Face, Legs, Cry, Consolabiliy scale .
Self-reporting of subjective pain using Visual analogue scale.
Post extraction instructions are given to the patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel-group and allocation ratio (1:1) Intervention: virtual reality glasses. Control: audiodistraction using music
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
audiovisual distraction
Arm Type
Experimental
Arm Title
audiodistraction
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
virtual reality glasses
Other Intervention Name(s)
audiovisual distraction
Intervention Description
a system composed of a head-mounted wide view display placed in front of the eyes and headphones placed in ears, it has the ability to block the real-world stimuli. This could distract the patient from the dental environment, which helps reduce anxiety
Intervention Type
Device
Intervention Name(s)
music
Other Intervention Name(s)
audiodistraction
Intervention Description
Music can be used to distract patients from the anxiety provoking stimulus. It helps the patient to escape from the stressful reality as it activates imaginary. Psychosocially music can offer peace and comfort to patients during dental treatment as it helps in making the environment less threatening.
Primary Outcome Measure Information:
Title
preoperative anxiety
Description
Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter in beat per minute unit (BPM)
Time Frame
before administration of local anesthesia
Title
postoperative anxiety
Description
using a fingertip pulse oximeter in beat per minute unit (BPM)
Time Frame
immediately after dental extraction
Title
preoperative anxiety
Description
RMS-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial scale) before administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
Time Frame
before administration of local anesthesia
Title
postoperative anxiety
Description
S-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial scale) immediatly after extraction in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
Time Frame
immediately after dental extraction
Secondary Outcome Measure Information:
Title
subjective pain
Description
using Visual analogue scale (vas scale) (0-10) , self reported pain as the child choose a number from 0 to 10 which describes the intensity of his or her pain.
0 =no pain 10=extreme pain.
Time Frame
immediately after extraction.
Title
objective pain
Description
using FLCCS (0-10)valuated by the outcomes assessor. The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain
Time Frame
during dental extraction procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children aged 5-8 years.
Children without any mental or systemic disorder.
Children need extraction of primary molars under local anesthesia.
Exclusion Criteria:
Children with visual impairment.
Children with hearing disabilities.
Patients or caregivers who refuse to sign the consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
omneya Ahmed Abdelrazik, B.D.S Cairo university
Phone
00201016300046
Email
omneya.saleh@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33605356
Citation
CustOdio NB, Cademartori MG, Azevedo MS, Mendes MA, Schardozim LR, Costa LRRSD, Goettems ML. Efficacy of audiovisual distraction using eyeglasses during dental care: a randomized clinical trial. Braz Oral Res. 2021 Feb 12;35:e26. doi: 10.1590/1807-3107bor-2021.vol35.0026. eCollection 2021.
Results Reference
result
PubMed Identifier
31879625
Citation
Packyanathan JS, Lakshmanan R, Jayashri P. Effect of music therapy on anxiety levels on patient undergoing dental extractions. J Family Med Prim Care. 2019 Dec 10;8(12):3854-3860. doi: 10.4103/jfmpc.jfmpc_789_19. eCollection 2019 Dec.
Results Reference
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PubMed Identifier
34172032
Citation
Felemban OM, Alshamrani RM, Aljeddawi DH, Bagher SM. Effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients: a randomized clinical trial. BMC Oral Health. 2021 Jun 25;21(1):321. doi: 10.1186/s12903-021-01678-x.
Results Reference
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PubMed Identifier
31723668
Citation
Nunna M, Dasaraju RK, Kamatham R, Mallineni SK, Nuvvula S. Comparative evaluation of virtual reality distraction and counter-stimulation on dental anxiety and pain perception in children. J Dent Anesth Pain Med. 2019 Oct;19(5):277-288. doi: 10.17245/jdapm.2019.19.5.277. Epub 2019 Oct 30.
Results Reference
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29415697
Citation
Scheerman JFM, van Meijel B, van Empelen P, Kramer GJC, Verrips GHW, Pakpour AH, Van den Braak MCT, van Loveren C. Study protocol of a randomized controlled trial to test the effect of a smartphone application on oral-health behavior and oral hygiene in adolescents with fixed orthodontic appliances. BMC Oral Health. 2018 Feb 7;18(1):19. doi: 10.1186/s12903-018-0475-9.
Results Reference
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PubMed Identifier
33245591
Citation
Grisolia BM, Dos Santos APP, Dhyppolito IM, Buchanan H, Hill K, Oliveira BH. Prevalence of dental anxiety in children and adolescents globally: A systematic review with meta-analyses. Int J Paediatr Dent. 2021 Mar;31(2):168-183. doi: 10.1111/ipd.12712. Epub 2020 Sep 9.
Results Reference
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PubMed Identifier
31266156
Citation
Dahlander A, Soares F, Grindefjord M, Dahllof G. Factors Associated with Dental Fear and Anxiety in Children Aged 7 to 9 Years. Dent J (Basel). 2019 Jul 1;7(3):68. doi: 10.3390/dj7030068.
Results Reference
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Citation
Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.
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Citation
Lopez-Valverde N, Muriel Fernandez J, Lopez-Valverde A, Valero Juan LF, Ramirez JM, Flores Fraile J, Herrero Payo J, Blanco Antona LA, Macedo de Sousa B, Bravo M. Use of Virtual Reality for the Management of Anxiety and Pain in Dental Treatments: Systematic Review and Meta-Analysis. J Clin Med. 2020 Apr 5;9(4):1025. doi: 10.3390/jcm9041025.
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Citation
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Effect of Virtual Reality Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment
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