Pediatric Dental AnxietyNCT07617662
Brainwave Entrainment Technique in Managing Anxiety and Pain Perception in Pediatric Dental Patients.
A study testing Brainwave entrainment and Basic behavioral management technique in people with Pediatric Dental Anxiety and Pediatric Dental Pain, run by Alexandria University at 1 site in Egypt.
Trial summary
Pediatric dental anxiety and pain management present significant clinical challenges during routine treatment. While conventional behavior management techniques exist, their inconsistent effectiveness necessitates the continuous search for alternative solutions. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Pediatric Dental Anxiety, Pediatric Dental Pain
- What is being tested?
- Brainwave entrainment and Basic behavioral management technique
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 31 Aug 2026
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants enrolled in the study will be selected after fulfilling the following inclusion criteria:
- Healthy six to nine years old.
- Frankl behavioural rating score 2 during preoperative assessment
- Bilateral mandibular primary molars indicated for extraction.
- Written guardian consent.
Who cannot join
- Children with:
- Physical disabilities or psychiatric disorders
- Epilepsy.
- Visual or hearing disabilities
- On photophobia inducing or hearing altering medications.
- Hypersensitivity to local anesthetic drugs used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Brainwave Entrainment on Anxiety and Pain Perception in Pediatric Dental Patients (A Randomized Controlled Clinical Trial)
Pediatric dental anxiety and pain management present significant clinical challenges during routine treatment. While conventional behavior management techniques exist, their inconsistent effectiveness necessitates the continuous search for alternative solutions. Brainwave entrainment (BWE) , a novel approach using audiovisual stimuli to induce relaxing alpha waves (8-12 Hz) , shows promise in anxiety and pain management. However, its application in pediatric dentistry remains insufficiently explored, particularly for invasive dental procedures.
- Conditions
- Pediatric Dental Anxiety, Pediatric Dental Pain
- Being tested
- Brainwave entrainment, Basic behavioral management technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainwave entrainmentDevice
Children allocated ot this group will undergo 5.5 minutes of brainwave entrainment before dental treatment. This will be delivered through a headset and a multicolored eyeset compatible with smartphones with eyes closed.The entrainment device will be introduced to the children and the parents. The children will be given time to accommodate with the device before starting theprocedure and will undergo an entrainment stimulation. The frequency will be set at 10 Hz and the volume level will be set around 60dB to ensure uniformity among participants. However patients will have the option to modify the volume settings if they encounter discomfort.
Basic behavioral management techniqueBehavioural
Children allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do).
| Study group | Role | What they receive |
|---|---|---|
| brainwave entrainment group | Experimental | Children allocated to this group will undergo 5.5 minutes of brainwave entrainment before dental treatment. This will be delivered through a headset and a multicolored eyeset compatible with smartphones with eyes closed.The entrainment device will be introduced to the children and the parents. The children will be given time to accommodate with the device before starting theprocedure and will undergo an entrainment stimulation. The frequency will be set at 10 Hz and the volume level will be set around 60dB to ensure uniformity among participants. However patients will have the option to modify the volume settings if they encounter discomfort. Receives: Device: Brainwave entrainment |
| Basic behavior management technique | Active comparator | Children allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do). Receives: Behavioral: Basic behavioral management technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental anxiety assessment using Facial Image Scale
The FIS comprises one item with a response set of five faces (ranging from a very sad to a very smiley face). Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling
Measured: At baseline (preoperatively) - Immediately after extraction (postoperatively)
Secondary outcomes (4)
Dental anxiety assessment using Pulse rate
The pulse rate will be measured using a pulse oximeter
Measured: At baseline (preoperatively) - during injection - during extraction - immediately after extraction (postoperatively)
Dental anxiety assessment using Venham's Clinical Anxiety Scale
VCAS rates the child's anxiety into 6 categories with scores ranging from 0 to 5. A score of 0 means low anxiety and a score of 5 refers to debilitating anxiety so much so that the child is out of contact with the reality of the threat and the requirement of physical restraint. The operator will assign a score to each child based on the child's response by analvsis of the recorded videotape.
Measured: At baseline (preoperatively) - during needle penetration - during extraction - immediately after extraction (postoperatively)
Dental pain assessment using Faces Pain Scale - Revised
The Faces pain scale - Revised features 6 gender neutral faces arranged horizontally, showing increasing levels of pain from "no pain" (leftmost face, scored as 0) to "very much pain" (rightmost face, scored as 10). Children will be asked to point to the face that best matches their pain level.
Measured: Immediately after injection - Immediately after extraction
Dental pain assessment using Face, Legs, Activity, Cry, Consolability Scale
It evaluates 5 behavioral categories namely Face, Legs, Activity, Cry, Consolability. Each category is scored 0-2, yielding a total pain score of 0-10 (higher = more severe pain). The operator will assign a score to each category based on the child's response by analysis of the recorded videotape.
Measured: During injection - During extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jun 2026
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malak Hazem, Alexandria University
- Investigators
- Abdelwahab Samaha, PHD, Study director, Alexandria UniversityNadia Aziz Wahba, PHD, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617662
- Sponsor's protocol ID
- 1128-08/2025
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Brainwave Entrainment on Anxiety and Pain Perception in Pediatric Dental Patients (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07617662
- Acronym / sponsor ID
- 1128-08/2025
- Conditions
- Pediatric Dental Anxiety, Pediatric Dental Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 1 Jun 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.
Pediatric dental anxiety and pain management present significant clinical challenges during routine treatment. While conventional behavior management techniques exist, their inconsistent effectiveness necessitates the continuous search for alternative solutions. Brainwave entrainment (BWE) , a novel approach using audiovisual stimuli to induce relaxing alpha waves (8-12 Hz) , shows promise in anxiety and pain management. However, its application in pediatric dentistry remains insufficiently explored, particularly for invasive dental procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brainwave entrainment group | Experimental | Device: Brainwave entrainmentChildren allocated to this group will undergo 5.5 minutes of brainwave entrainment before dental treatment. This will be delivered through a headset and a multicolored eyeset compatible with smartphones with eyes closed.The entrainment device will be introduced to the children and the parents. The children will be given time to accommodate with the device before starting theprocedure and will undergo an entrainment stimulation. The frequency will be set at 10 Hz and the volume level will be set around 60dB to ensure uniformity among participants. However patients will have the option to modify the volume settings if they encounter discomfort. |
| Basic behavior management technique | Active comparator | Behavioral: Basic behavioral management techniqueChildren allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do). |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participants enrolled in the study will be selected after fulfilling the following inclusion criteria:
Key exclusion criteria (6 listed)
- Children with:
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 |
|---|---|---|
| Brainwave entrainmentChildren allocated ot this group will undergo 5.5 minutes of brainwave entrainment before dental treatment. This will be delivered through a headset and a multicolored eyeset compatible with smartphones with eyes closed.The entrainment device will be introduced to the children and the parents. The children will be given time to accommodate with the device before starting theprocedure and will undergo an entrainment stimulation. The frequency will be set at 10 Hz and the volume level will be set around 60dB to ensure uniformity among participants. However patients will have the option to modify the volume settings if they encounter discomfort. | Device | brainwave entrainment group |
| Basic behavioral management techniqueChildren allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do). | Behavioural | Basic behavior management technique |
Primary outcome
Dental anxiety assessment using Facial Image Scale
Time frame: At baseline (preoperatively) - Immediately after extraction (postoperatively)
The FIS comprises one item with a response set of five faces (ranging from a very sad to a very smiley face). Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling
4 secondary outcomes
Dental anxiety assessment using Pulse rate
Time frame: At baseline (preoperatively) - during injection - during extraction - immediately after extraction (postoperatively)
Dental anxiety assessment using Venham's Clinical Anxiety Scale
Time frame: At baseline (preoperatively) - during needle penetration - during extraction - immediately after extraction (postoperatively)
Dental pain assessment using Faces Pain Scale - Revised
Time frame: Immediately after injection - Immediately after extraction
Dental pain assessment using Face, Legs, Activity, Cry, Consolability Scale
Time frame: During injection - During extraction
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 1 Oct 2026.
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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.
Abdelwahab Samaha, PHD study director
Alexandria University
Nadia Aziz Wahba, 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 Brainwave entrainment and Basic behavioral management technique in people with Pediatric Dental Anxiety and Pediatric 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 5 inclusion and 6 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 1 Oct 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. 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?
Dental anxiety assessment using Facial Image Scale (time frame: At baseline (preoperatively) - Immediately after extraction (postoperatively)). 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 1 Oct 2026.