Dental PainNCT07411157
Technology-based Distraction Techniques in Managing Children With Attention-deficit/Hyperactivity Disorder
A study testing Virtual reality glasses, White noise and Basic behavior management techniques in people with Dental Pain, run by Alexandria University at 1 site in Egypt.
Trial summary
The present study aims to assess and compare the effectiveness of different technology-based distraction techniques on pain perception and dental anxiety in children with Attention Deficit/Hyperactivity Disorder during different dental procedures Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Dental Pain
- What is being tested?
- Virtual reality glasses, White noise and Basic behavior management techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with ADHD according to the DSM-V criteria and diagnosis confirmed by a pediatric neurologist.
- All children should be on stimulant medication.
- No previous dental experience.
- Written consent of the legal guardian.
Who cannot join
- Children with physical disabilities or other psychiatric disorders.
- Children with visual or hearing disabilities.
- Patients requiring emergency treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric Neurology Outpatient Clinic, Faculty of Medicine, Alexandria University, Egypt
Alexandria, Alexandria Governorate, 21527
About this study
Official title: Effectiveness of Technology-based Distraction Techniques on Pain Perception of Children With Attention-deficit Hyperactivity Disorder During Different Dental Procedures: A Randomized Controlled Clinical Trial
The present study aims to assess and compare the effectiveness of different technology-based distraction techniques on pain perception and dental anxiety in children with Attention Deficit/Hyperactivity Disorder during different dental procedures
- Conditions
- Dental Pain
- Being tested
- Virtual reality glasses, White noise, Basic behavior management techniques
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality glassesBehavioural
Children allocated to this group were distracted using VR glasses during dental treatment which is an individual headset that has earphones incorporated. Age-appropriate cartoons and movies were shown to the children. The VR glasses were then introduced to the children. The children were given time to accommodate with the device before starting the procedure. The VR glasses were applied during the treatment.
White noiseBehavioural
Wireless kids' headphones were introduced to the children allocated to this group. They were given some time to accommodate with the headphones. Then, the white noise was played and children were asked to concentrate on the music during the procedure. White noise stimulus was set at 70decibels, within the "normal conversation" volume range and below what is considered harmful to hearing. The white noise of rain sound, managed with an iPhone application called Muse. The decibel level of white noise was calibrated using a portable digital sound level meter
Basic behavior management techniquesBehavioural
Children allocated to this group were managed by the basic behavior guidance techniques: (Tell-ShowDo). No adjunctive distraction tool were used.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality glasses | Experimental | Not described Receives: Behavioral: Virtual reality glasses |
| White noise | Active comparator | Not described Receives: Behavioral: White noise |
| Basic behavior management techniques | Sham comparator | Not described Receives: Behavioral: Basic behavior management techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-related behavior
Children's behavior using the revised Face, Leg, Activity, Cry, Consolability scale (r-FLACC). The r-FLACC scale has been identified as a recommended measurement tool for assessing pain in children aged 0 to 18 years, with a high level of intra- and inter-reliability. Each of the r-FLACC's categories is scored from 0 to 2, which results in a total score between 0 and 10: 0 'relaxed and comfortable'; 1-3 'mild discomfort'; 4-6 'moderate pain'; and 7-10 'severe pain or discomfort or both. The operator assigned a score to each child based on the child's behavior by analysis of the recorded videotape.
Measured: The scores were assessed perioperative at 4 procedures: • During needle penetration. • During rubber dam clamp application. • During caries removal. • During placement of composite restoration.
Secondary outcomes (2)
Pulse rate
The pulse rate was measured using a pulse oximeter. Normal range is considered from 70-110.
Measured: The pulse rate was recorded at the baseline and perioperative during needle penetration, rubber dam clamp application, caries removal, placement of composite restoration, and postoperatively after composite finishing and occlusal adjustment.
Self reported pain
Self-reported pain was measured using the Wong-Baker FACES rating scale using six cartoon faces, from a broad smile (0, "No Hurt") to a tearful frown (10, "Hurts Worst"), to help children indicate their pain level, with scores increasing by twos (0, 2, 4, 6, 8, 10) to represent mild to severe pain.
Measured: The scale was administered at the baseline (preoperative) and postoperatively at the end of the visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start10 Jul 2023
- Primary completion1 Dec 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Aly, Alexandria University
- Investigators
- Nahla A. Aly, MSc, Principal investigator, Alexandria UniversityAmina M. Abdelrahman, PhD, Study director, Alexandria UniversityKarin ML Dowidar, PhD, Study chair, Alexandria UniversityTarek Omar, PhD, Study director, Alexandria UniversityNourhan M. Aly, PhD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411157
- Sponsor's protocol ID
- 9205200
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Technology-based Distraction Techniques on Pain Perception of Children With Attention-deficit Hyperactivity Disorder During Different Dental Procedures: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07411157
- Acronym / sponsor ID
- 9205200
- Conditions
- Dental Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to assess and compare the effectiveness of different technology-based distraction techniques on pain perception and dental anxiety in children with Attention Deficit/Hyperactivity Disorder during different dental procedures
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual reality glasses | Experimental | Behavioral: Virtual reality glasses |
| White noise | Active comparator | Behavioral: White noise |
| Basic behavior management techniques | Sham comparator | Behavioral: Basic behavior management techniques |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children diagnosed with ADHD according to the DSM-V criteria and diagnosis confirmed by a pediatric neurologist.
- All children should be on stimulant medication.
- No previous dental experience.
- Written consent of the legal guardian.
Key exclusion criteria (3 listed)
- Children with physical disabilities or other psychiatric disorders.
- Children with visual or hearing disabilities.
- Patients requiring emergency treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality glassesChildren allocated to this group were distracted using VR glasses during dental treatment which is an individual headset that has earphones incorporated. Age-appropriate cartoons and movies were shown to the children. The VR glasses were then introduced to the children. The children were given time to accommodate with the device before starting the procedure. The VR glasses were applied during the treatment. | Behavioural | Virtual reality glasses |
| White noiseWireless kids' headphones were introduced to the children allocated to this group. They were given some time to accommodate with the headphones. Then, the white noise was played and children were asked to concentrate on the music during the procedure. White noise stimulus was set at 70decibels, within the "normal conversation" volume range and below what is considered harmful to hearing. The white noise of rain sound, managed with an iPhone application called Muse. The decibel level of white noise was calibrated using a portable digital sound level meter | Behavioural | White noise |
| Basic behavior management techniquesChildren allocated to this group were managed by the basic behavior guidance techniques: (Tell-ShowDo). No adjunctive distraction tool were used. | Behavioural | Basic behavior management techniques |
Primary outcome
Pain-related behavior
Time frame: The scores were assessed perioperative at 4 procedures: • During needle penetration. • During rubber dam clamp application. • During caries removal. • During placement of composite restoration.
Children's behavior using the revised Face, Leg, Activity, Cry, Consolability scale (r-FLACC). The r-FLACC scale has been identified as a recommended measurement tool for assessing pain in children aged 0 to 18 years, with a high level of intra- and inter-reliability. Each of the r-FLACC's categories is scored from 0 to 2, which results in a total score between 0 and 10: 0 'relaxed and comfortable'; 1-3 'mild discomfort'; 4-6 'moderate pain'; and 7-10 'severe pain or discomfort or both. The operator assigned a score to each child based on the child's behavior by analysis of the recorded videotape.
2 secondary outcomes
Pulse rate
Time frame: The pulse rate was recorded at the baseline and perioperative during needle penetration, rubber dam clamp application, caries removal, placement of composite restoration, and postoperatively after composite finishing and occlusal adjustment.
Self reported pain
Time frame: The scale was administered at the baseline (preoperative) and postoperatively at the end of the visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Yes
Related trials for Dental Pain
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Recruiting
Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
Anesthesia, Anxiety
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
Recruiting
Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
Dental Anxiety, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nahla A. Aly, MSc principal investigator
Alexandria University
Amina M. Abdelrahman, PhD study director
Alexandria University
Karin ML Dowidar, PhD study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality glasses, White noise and Basic behavior management techniques in people with Dental Pain, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-related behavior (time frame: The scores were assessed perioperative at 4 procedures: • During needle penetration. • During rubber dam clamp application. • During caries removal. • During placement of composite restoration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.