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| ID | Type | Description | Link |
|---|---|---|---|
| OMSBoard-2026 | Other Grant/Funding Number | Oman Medical Specialty Board |
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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, SpOâ‚‚), and behavioral cooperation (Frankl scale).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Virtual Reality Distraction | Experimental | 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 |
|
| Arm 2: Audio-Visual Distraction | Active Comparator | 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. |
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| Arm 3: Conventional Tell-Show-Do | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 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). | 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 (SpOâ‚‚) | Oxygen saturation will be monitored using a pulse oximeter. The unit of measure is percentage (%). In healthy children, normal SpOâ‚‚ values are typically 95-100% at rest. Lower values indicate poorer physiological status (i.e., worse outcomes). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at the end of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr.Zamzam AlQulhati Ali AlQulhati, BDS, MFD ( RSCI) | Contact | +96895573313 | zalqulhati@gmail.com | |
| Azza AlShidhani Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd) | Contact | +96895692669 | azzak@squ.edu.om |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Azza Khalid AlSHidhani, DclinDent (Ed), MPaeds (RCSEd) | Pediatric dental clinic , Dental and maxillofacial department (SQUH), University Medical City, | Study Director |
| Dr. Khalifa Mohammed AlAzri, DclinDent (Ed), MPaeds (RCSEd) | Pediatric dental clinic, Dental Center (Alkhoudh), The Medical City of Military and Security Services |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sultan Qaboos University Hospital - Dental & Maxillofacial Department | Muscat | Oman |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38087294 | Background | Barros Padilha DX, Veiga NJ, Mello-Moura ACV, Nunes Correia P. Virtual reality and behaviour management in paediatric dentistry: a systematic review. BMC Oral Health. 2023 Dec 12;23(1):995. doi: 10.1186/s12903-023-03595-7. | |
| 39465519 | Background | Kasimoglu Y, Alpaycetin E, Ince G, Tuna Ince EB. Reduction of Dental Anxiety in Children Using Virtual Reality: A Randomised Controlled Trial. Eur J Paediatr Dent. 2025 Sep 1;26(3):185-191. doi: 10.23804/ejpd.2024.2109. Epub 2024 Oct 1. |
| Label | URL |
|---|---|
| Royal College of Surgeons of England. (n.d.). Non-pharmacological behavior management in dentistry. The Royal College of Surgeons of England. | View source |
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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.
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This is a three-arm, parallel group randomized controlled trial in children aged 6-10 years undergoing simple dental extraction. Participants are assigned to virtual reality distraction, audio-visual distraction, or conventional tell-show-do. The study is open-label with outcomes assessed at baseline, injection, extraction, and post-procedure.
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| 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. |
|
| 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 |
| Child Behavior (Observation) | Child behavior will be assessed using the Frankl Behavior Rating Scale. This scale has four degrees:
The total score range is 1 to 4. Higher scores indicate more cooperative behavior (better outcome). | Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure |
| Study Director |
| Dr. Zamzam Ali Alqulhati, BDS, MFD(RCSI) | Oman Medical Specialty Boaered | Principal Investigator |
| The Medical City of Military and Security Service (Dental Center-AlKhoudh ) | Muscat | Oman |
|
| 34300185 | Background | Gomez-Polo C, Vilches AA, Ribas D, Castano-Seiquer A, Montero J. Behaviour and Anxiety Management of Paediatric Dental Patients through Virtual Reality: A Randomised Clinical Trial. J Clin Med. 2021 Jul 7;10(14):3019. doi: 10.3390/jcm10143019. |