Virtual Reality Glasses Integrated With Sign Language on Dental Anxiety Among Children With Hearing Impairment During Pulpotomy Procedure

Sponsor
Hams Hamed Abdelrahman (Other)
Overall Status
Recruiting
CT.gov ID
NCT06153823
Collaborator
(none)
40
1
2
5
8

Study Details

Study Description

Brief Summary

To evaluate the impact of using virtual reality glasses using sign language as a distraction method to reduce the dental anxiety in moderate to severe hearing-impaired children compared to the conventional behavior management technique during pulpotomy treatment.

The study will be a randomized controlled parallel two arms clinical trial, a total of 40 healthy children aged 5-7 years with moderate to severe hearing disability, will be selected from Pediatric Dentistry and dental public health Department, Faculty of Dentistry, Alexandria University, Egypt. Children selected should have at least one primary molar indicated for pulpotomy. The eligible participants will be randomly assigned to one of two groups: the study group, which will use virtual reality glasses with sign language as a distraction method to manage children's behavior, and the control group, which will use the conventional behavior management strategies including show-tell-do, and positive reinforcement. Local anesthesia will be given and pulpotomy procedure will be done on the selected tooth followed by stainless steel crown restoration. Pre and post-operative assessment of child's dental anxiety will be done using three methods: physiologically using pulse oximeter for measuring the heart rate, objectively using Venham clinical anxiety rating scale, and subjectively using the modified facial image scale.

Condition or Disease Intervention/Treatment Phase
  • Other: virtual reality glasses
  • Other: Tell Show and Do
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Virtual Reality Glasses Integrated With Sign Language on Dental Anxiety Among Children With Hearing Impairment During Pulpotomy Procedure (Randomized Controlled Clinical Trial)
Actual Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: virtual reality glasses

Other: virtual reality glasses
child behavior management will be done by using VR glasses distraction

Active Comparator: show-tell-do technique.

Other: Tell Show and Do
child behavior management will be done by using tell show and do technique

Outcome Measures

Primary Outcome Measures

  1. Change in child anxiety level [up to 2 months]

    This objective measure scores the child's level of anxiety with a correlating behavior description It consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact.

Secondary Outcome Measures

  1. Change in heart rate [up to 2 months]

    Heart rate (HR) is a physiological sign of pain. It will be measured using a pulse oximeter

  2. Change in child anxiety level by subjective method [up to 2 months]

    A modified face scale will be used to subjectively record anxiety . It consists of three schematic faces with different facial expressions for happy and sad faces representing: (A) satisfaction; (B) indifference; and (C) dissatisfaction, respectively

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 7 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Children with Frankl behavior rating score 2 or 3.

  • Children requiring pulpotomy in one of their primary molars.

  • Parents who accepted to give their consent and participate in the study.

Exclusion Criteria:
  • Children with any medical condition other than hearing disability (ASA II, III & IV).

  • Syndromic children with hearing impairment.

  • Children with previous bad dental experience.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alexandria Faculty of Dentistry Alexandria Egypt

Sponsors and Collaborators

  • Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
ClinicalTrials.gov Identifier:
NCT06153823
Other Study ID Numbers:
  • 0665-04/2023
First Posted:
Dec 1, 2023
Last Update Posted:
Dec 1, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2023