Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-10
SponsorSultan Qaboos University

About this trial

The goal of this clinical trial is to learn if virtual reality distraction can reduce dental anxiety and pain perception in children aged 6-10 years undergoing simple dental extraction. The main questions it aims to answer are:

Does virtual reality distraction lower dental anxiety compared to audio-visual distraction and conventional tell-show-do techniques?

Does virtual reality distraction reduce pain perception during dental extraction?

Researchers will compare virtual reality distraction, audio-visual distraction (2D cartoons with headset), and conventional tell-show-do with verbal distraction to see which method is most effective in improving child cooperation and reducing anxiety and pain.

Participants will:

Wear VR glasses to watch immersive 3D cartoons, or

Watch 2D cartoons with headset, or

Receive the conventional tell-show-do technique with verbal distraction.

Outcome measures will include child dental anxiety (CFSS-DS, VCARS), pain perception (Wong-Baker FACES), physiological parameters (pulse rate, SpO₂), and behavioral cooperation (Frankl scale).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 6 to 10 years

Classified as ASA class 1 or 2 (healthy or with mild systemic disease)

Those who demonstrated Frankl behavior rating 2 and 3 toward dental procedures

Children with NO previous exposure to invasive dental procedure

Disqualifiers

ASA 3 and above

Those who demonstrated Frankl behavior rating 1 and 4 toward dental procedures

Special needs ( intellectual and developmental)

Children on psychotropic medication

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual reality headset

    Device

    Children wear a virtual reality headset to watch immersive 3D cartoons during dental extraction. This device provides distraction to reduce dental anxiety and pain perception.

  • Audio-visual distraction with 2D cartoons

    Behavioral

    Children watch 2D cartoons with headset during dental extraction. This behavioral technique provides distraction to reduce dental anxiety and pain perception.

  • Tell-show-do with verbal distraction

    Behavioral

    Children receive the standard tell-show-do technique with verbal distraction during dental extraction. This behavioral method is used to reduce dental anxiety and improve cooperation.

Treatment groups

168 Participants
are divided into 3 treatment groups
Group A: Arm 1: Virtual Reality DistractionExperimental treatment 1 intervention
Group B: Arm 2: Audio-Visual DistractionActive comparator 1 intervention
Group C: Arm 3: Conventional Tell-Show-DoActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Child Dental Anxiety (Self-Report)

Change in child dental anxiety will be measured using the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS, Arabic version). The CFSS-DS consists of 15 items, each scored from 1 (not afraid) to 5 (very afraid), yielding a total score range of 15 to 75. Higher scores indicate greater dental anxiety (worse outcome). The unit of measure is the CFSS-DS score.

Time frame
Time Points: Baseline (before starting the procedure) and post-operative assessments ( after finishing the extraction)
2

Child Dental Anxiety (Observation-based Assessment)

Change in child dental anxiety will also be assessed using Venham's Clinical Anxiety Rating Scale (VCARS). This observational scale is scored from 0 (relaxed) to 5 (out of control), with a total score range of 0 to 5. Higher scores indicate greater observed anxiety (worse outcome).

Time frame
Time points: This scale will be measured at 4 time points during the procedure: T0(baseline)= 15 min before starting the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 mins after the extraction
3

3a: Physiological Monitoring - Pulse Rate

Pulse rate will be monitored using a pulse oximeter. The unit of measure is beats per minute (bpm). In children, the normal resting pulse rate varies by age: Preschool children (3-5 years): \~80-120 bpm School-aged children (6-12 years): \~70-118 bpm Adolescents (13-18 years): \~60-100 bpm Higher values during the dental procedure indicate greater physiological arousal (worse outcome).

Time frame
Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction
4

3b: Physiological Monitoring - Oxygen Saturation (SpO₂)

Oxygen saturation will be monitored using a pulse oximeter. The unit of measure is percentage (%). In healthy children, normal SpO₂ values are typically 95-100% at rest. Lower values indicate poorer physiological status (i.e., worse outcomes).

Time frame
Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction

Secondary outcomes

1

Pain Perception (Self-Report)

Self-reported pain perception will be measured using the Wong-Baker FACES Pain Rating Scale (Arabic version). This scale ranges from 0 (no pain) to 10 (worst pain), represented by facial expressions. Higher scores indicate greater pain intensity (worse outcome), and lower scores indicate less pain intensity (better outcome)

Time frame
at the end of the procedure
2

Child Behavior (Observation)

Child behavior will be assessed using the Frankl Behavior Rating Scale. This scale has four degrees: 1. (Definitely Negative): Refusal of treatment, forceful crying, fearfulness, or extreme negativism. 2. (Negative): Reluctant to accept treatment, uncooperative, some negative attitude but not pronounced. 3. (Positive): Acceptance of treatment, cautious behavior, willingness to comply with the dentist, sometimes with reservation. 4. (Definitely Positive): Good rapport with the dentist, interested in dental procedures, laughing and enjoying the situation. The total score range is 1 to 4. Higher scores indicate more cooperative behavior (better outcome).

Time frame
Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: