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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dental Anxiety

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 6, 2021
    Last Updated
    May 9, 2022
    Sponsor
    Cairo University
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    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
    result
    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
    result
    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
    result
    PubMed Identifier
    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
    result
    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
    result
    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
    result
    PubMed Identifier
    32694387
    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.
    Results Reference
    result
    PubMed Identifier
    32260538
    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.
    Results Reference
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    PubMed Identifier
    32440041
    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.
    Results Reference
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    Effect of Virtual Reality Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment

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