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

May 9, 2022 updated by: Omneya Ahmed AbdelRazik saleh, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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:

  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.

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: audiovisual distraction
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
Other Names:
  • audiovisual distraction
Experimental: audiodistraction
Device: 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.
Other Names:
  • audiodistraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preoperative anxiety
Time Frame: before administration of local anesthesia
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
Time Frame: immediately after dental extraction
using a fingertip pulse oximeter in beat per minute unit (BPM)
immediately after dental extraction
preoperative anxiety
Time Frame: before administration of local anesthesia
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
Time Frame: immediately after dental extraction
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective pain
Time Frame: immediately after extraction.

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.
objective pain
Time Frame: during dental extraction procedure.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

October 6, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dental anxiety reduction

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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