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

NCT05083988 | Unknown

• 1 other identifier: Dental anxiety reduction
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (4)

• 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

• postoperative anxiety

  using a fingertip pulse oximeter in beat per minute unit (BPM)

  immediately after dental extraction

• 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

• 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 Outcomes (2)

• subjective pain

  immediately after extraction.

• objective pain

  during dental extraction procedure.

Study Arms (2)

audiovisual distraction

EXPERIMENTAL

Device: virtual reality glasses

audiodistraction

EXPERIMENTAL

Device: music

Interventions

virtual reality glasses DEVICE

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

Also known as: audiovisual distraction

audiovisual distraction

music DEVICE

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.

Also known as: audiodistraction

audiodistraction

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 5-8 years.
• Children without any mental or systemic disorder.
• Children need extraction of primary molars under local anesthesia.

You may not qualify if:

• Children with visual impairment.
• Children with hearing disabilities.
• Patients or caregivers who refuse to sign the consent.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (10)

• 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.

  PMID: 33605356 RESULT

• 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.

  PMID: 31879625 RESULT

• 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.

  PMID: 34172032 RESULT

• 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.

  PMID: 31723668 RESULT

• 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.

  PMID: 29415697 RESULT

• 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.

  PMID: 33245591 RESULT

• 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.

  PMID: 31266156 RESULT

• 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.

  PMID: 32694387 RESULT

• 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.

  PMID: 32260538 RESULT

• 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.

  PMID: 32440041 RESULT

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

omneya Ahmed Abdelrazik, B.D.S Cairo university

CONTACT

00201016300046; omneya.saleh@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: parallel-group and allocation ratio (1:1) Intervention: virtual reality glasses. Control: audiodistraction using music

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share