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

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ClinicalTrials.gov Identifier: NCT05083988
Recruitment Status : Not yet recruiting
First Posted : October 19, 2021
Last Update Posted : May 12, 2022
Sponsor:
Information provided by (Responsible Party):
Omneya Ahmed AbdelRazik saleh, Cairo University

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.

Condition or disease Intervention/treatment Phase
Dental Anxiety Device: virtual reality glasses Device: music Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: parallel-group and allocation ratio (1:1) Intervention: virtual reality glasses. Control: audiodistraction using music
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of Virtual Reality Distraction Versus Audio Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment (A Randomized Clinical Trial)
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: audiodistraction




Primary Outcome Measures :
  1. 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)

  2. postoperative anxiety [ Time Frame: immediately after dental extraction ]
    using a fingertip pulse oximeter in beat per minute unit (BPM)

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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.


  2. 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



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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05083988


Contacts
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Contact: omneya Ahmed Abdelrazik, B.D.S Cairo university 00201016300046 omneya.saleh@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
Publications of Results:

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Responsible Party: Omneya Ahmed AbdelRazik saleh, principle investigator, Cairo University
ClinicalTrials.gov Identifier: NCT05083988    
Other Study ID Numbers: Dental anxiety reduction
First Posted: October 19, 2021    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders