An interventional study of Virtual reality headset and Audio-visual distraction with 2D cartoons in Dental Anxiety in Children and Pain Perception, sponsored by Sultan Qaboos University. Not yet recruiting at 2 sites in Oman. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Sultan Qaboos University · Not applicable, Interventional, and Supportive care
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).
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 168 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Sultan Qaboos University is the lead sponsor of 50 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children wear VR glasses to watch immersive 3D cartoons during dental extraction. Anxiety, pain, and cooperation are assessed using CFSS-DS, Wong-Baker FACES, VCARS, Frankl scale, and physiological parameters
Device: Virtual reality headset
Children watch 2D cartoons with headset during dental extraction. Anxiety, pain, and cooperation are measured using the same scales and physiological parameters as the VR group.
Behavioral: Audio-visual distraction with 2D cartoons
Children receive the standard tell-show-do technique with verbal distraction during dental extraction. Anxiety, pain, and cooperation are assessed using CFSS-DS, Wong-Baker FACES, VCARS, Frankl scale, and physiological parameters.
Behavioral: Tell-show-do with verbal distraction
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.
Children watch 2D cartoons with headset during dental extraction. This behavioral technique provides distraction to reduce dental anxiety and pain perception.
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.
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)
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
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
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
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
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
Plan to share: No — Individual participant data (IPD) will not be shared due to ethical considerations in pediatric populations, privacy concerns, and institutional policy. Only aggregated results will be published in peer-reviewed journals and presented at scientific meetings.
Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 11 months is close to that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Sultan Qaboos University