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NCT Number: NCT07693764

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

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).

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Key information

Conditions

Dental Anxiety in Children Pain Perception

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan Qaboos University Hospital - Dental & Maxillofacial Department, Muscat, Oman

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • No prior experience using VR glasses
  • Requiring extraction of mandibular deciduous molar under local anesthesia

Exclusion criteria

  • 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
  • Children wearing glasses
  • Presence of intra-oral swelling

Treatment and study plan

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.

Primary outcomes

  1. Child Dental Anxiety (Self-Report)

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

    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.

  2. Child Dental Anxiety (Observation-based Assessment)

    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

    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).

  3. 3a: Physiological Monitoring - Pulse Rate

    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

    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).

  4. 3b: Physiological Monitoring - Oxygen Saturation (SpO₂)

    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

    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).

Secondary outcomes

  1. Pain Perception (Self-Report)

    Time frame: at the end of the procedure

    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)

  2. Child Behavior (Observation)

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

    Child behavior will be assessed using the Frankl Behavior Rating Scale. This scale has four degrees:

    • (Definitely Negative): Refusal of treatment, forceful crying, fearfulness, or extreme negativism.
    • (Negative): Reluctant to accept treatment, uncooperative, some negative attitude but not pronounced.
    • (Positive): Acceptance of treatment, cautious behavior, willingness to comply with the dentist, sometimes with reservation.
    • (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).

Study contacts

Contact information is provided by the study sponsor or research team.

Azza AlShidhani Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)

CONTACT

[email protected]

+96895692669

Dr.Zamzam AlQulhati Ali AlQulhati, BDS, MFD ( RSCI)

CONTACT

[email protected]

+96895573313

Sponsors and collaborators

Lead sponsor

Sultan Qaboos University

Other

Registry information

Official study title

"Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction: A Randomized Controlled Trial"

Acronym: VR-PED

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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