Effect of Virtual Reality Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment

Dental Anxiety Clinical Trial

Official title:

Effect of Virtual Reality Distraction Versus Audio Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment (A Randomized Clinical Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05083988
• Other study ID #: Dental anxiety reduction
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Cairo University
• Contact: omneya Ahmed Abdelrazik, B.D.S Cairo university
• Phone: 00201016300046
• Email: omneya.saleh[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. Taking personal data, medical and dental history.

2. Diagnosis and determination of the required treatment.

3. Measuring preoperative anxiety (expressed by heart rate) using a pulse oximeter.

4. 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.

5. Administration of topical anesthesia.

6. Administration of local anesthesia.

7. Check the effectiveness of local anesthesia using dental probe.

8. Extraction of the affected tooth.

9. Measuring postoperative anxiety (expressed by heart rate) using the pulse oximeter.

10. Evaluate the objective pain using Face, Legs, Cry, Consolabiliy scale .

11. Self-reporting of subjective pain using Visual analogue scale.

12. Post extraction instructions are given to the patient.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

Device:
• virtual reality glasses
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
• music
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (10)

CustÓdio 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 — View Citation

Dahlander A, Soares F, Grindefjord M, Dahllöf G. Factors Associated with Dental Fear and Anxiety in Children Aged 7 to 9 Years. Dent J (Basel). 2019 Jul 1;7(3). pii: E68. doi: 10.3390/dj7030068. — View 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/s12903-0 — View 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. Ep — View Citation

López-Valverde N, Muriel Fernández J, López-Valverde A, Valero Juan LF, Ramírez 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: Systemat — View 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 — View 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. — View 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, — View 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 a — View Citation

Sivakumar P, Gurunathan D. Behavior of Children toward Various Dental Procedures. Int J Clin Pediatr Dent. 2019 Sep-Oct;12(5):379-384. doi: 10.5005/jp-journals-10005-1670. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preoperative anxiety	Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter in beat per minute unit (BPM)	before administration of local anesthesia
Primary	postoperative anxiety	using a fingertip pulse oximeter in beat per minute unit (BPM)	immediately after dental extraction
Primary	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	before administration of local anesthesia
Primary	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	immediately after dental extraction
Secondary	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.	immediately after extraction.
Secondary	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	during dental extraction procedure.