Tooth ExtractionAV AcupointNCT07371442
Effect of AV Distraction and Acuapoint Stimulation in Pediatric Extraction on Pain and Anxiety
A study testing Acualief, Audiovisual and TELL SHOW DO in people with Tooth Extraction and Local Anesthesia, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effectiveness of audiovisual distraction and acuapoint stimulation on anxiety and pain perception during tooth extraction in children. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction, Local Anesthesia, Anxiety
- What is being tested?
- Acualief, Audiovisual and TELL SHOW DO
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1- Children with behavior rating score 2,3 according to Frankl's behavior rating scale.
- 2- Children aged 5-8 years requiring primary tooth extraction. 3- Healthy children free of systemic diseases
Who cannot join
- 1- Children with special health care needs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Audiovisual Distraction and Acuapoint Stimulation on Anxiety and Pain Perception During Tooth Extraction in Children: A Randomized Controlled Clinical Study.
The aim of this study is to evaluate the effectiveness of audiovisual distraction and acuapoint stimulation on anxiety and pain perception during tooth extraction in children.
- Conditions
- Tooth Extraction, Local Anesthesia, Anxiety, Pain
- Being tested
- Acualief, Audiovisual, TELL SHOW DO
- Keywords
- Audiovisual, acuapoint, acupressure, TSD, pain, anxiety, tooth extraction
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcualiefDevice
Aculief acupressure device will be placed on the LI4 Point (figure 1) which is located on the hand between the thumb and index finger, also described as the depression where the index finger and thumb bone go apart. The LI4 point will be identified in each patient by asking the patient to adduct the thumb and index finger. The duration will be 5 minutes before LA administration.
The administration of local anesthesia in all groups will be achieved by 1.8 ml of 2% Lidocaine with 1/100,000 epinephrine using a 30-gauge long needle
AudiovisualDevice
A dental video story will be presented to the patient using an iPad device connected to a noise cancellation headphone.
TELL SHOW DOBehavioural
This group will be treated using Tell-show-do technique
| Study group | Role | What they receive |
|---|---|---|
| dental story | Experimental | A dental video story will be presented to patient using an iPad device connected to a noise cancellation headphone. Receives: Device: Audiovisual |
| Aculief | Experimental | Aculief acupressure device will be placed on the LI4 Point which is located on the hand between the thumb and index finger, also described as the depression where the index finger and thumb bone go apart. The LI4 point will be identified in each patient by asking the patient to adduct the thumb and index finger. The duration will be 5 minutes before LA administration. to patients Receives: Device: Acualief |
| TSD | Experimental | This group will be treated using Tell-show-do technique Receives: Behavioral: TELL SHOW DO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety will be measured by A) Pulse oximeter: Pulse oximeter was used to observe the physiological functions like heart rate and SpO₂.
- Venham's picture test: the child was presented with eight different cards. Each card held two pictures-a representation of the child expressing anxiety along with another representation of the same child in a relaxed mood. The child was asked to point out the picture in each pair that resembled how he/she was feeling. There was also an order in which the pictures had to be presented. Assigning the image depicting anxiety the score of 1 and the relaxed image the score of 0 helped in the coding process.
Measured: Will be measured 5 minutes before LA , immediately before extraction and immediately after extraction The total VPT score was obtained by summing the values across all eight panels, with higher scores indicating greater levels of anxiety (range: 0-8).
Secondary outcomes (1)
Pain of the patient
will be evaluated by Wong baker FACES pain scale which is consist of six faces numbered ordinary from 0 to 5. ranging from a no pain (score 0) to one showing severe pain (score 5)
Measured: Will be evaluated immediately after the local anesthesia and tooth extraction using Wong Baker FACES Pain rating scale, ranging from a no pain (score 0) to one showing severe pain (score 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start2 Feb 2025
- Primary completion15 Jul 2025
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371442
- Sponsor's protocol ID
- A03012024PP
- Acronym
- AV Acupoint
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Audiovisual Distraction and Acuapoint Stimulation on Anxiety and Pain Perception During Tooth Extraction in Children: A Randomized Controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT07371442
- Acronym / sponsor ID
- AV Acupoint / A03012024PP
- Conditions
- Tooth Extraction, Local Anesthesia, Anxiety, Pain
- Keywords
- Audiovisual, acuapoint, acupressure, TSD, pain, anxiety, tooth extraction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 28 Jan 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 aim of this study is to evaluate the effectiveness of audiovisual distraction and acuapoint stimulation on anxiety and pain perception during tooth extraction in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dental story | Experimental | Device: AudiovisualA dental video story will be presented to patient using an iPad device connected to a noise cancellation headphone. |
| Aculief | Experimental | Device: AcualiefAculief acupressure device will be placed on the LI4 Point which is located on the hand between the thumb and index finger, also described as the depression where the index finger and thumb bone go apart. The LI4 point will be identified in each patient by asking the patient to adduct the thumb and index finger. The duration will be 5 minutes before LA administration. to patients |
| TSD | Experimental | Behavioral: TELL SHOW DOThis group will be treated using Tell-show-do technique |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1- Children with behavior rating score 2,3 according to Frankl's behavior rating scale.
- 2- Children aged 5-8 years requiring primary tooth extraction. 3- Healthy children free of systemic diseases
Key exclusion criteria (1 listed)
- 1- Children with special health care needs.
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 |
|---|---|---|
| AcualiefAculief acupressure device will be placed on the LI4 Point (figure 1) which is located on the hand between the thumb and index finger, also described as the depression where the index finger and thumb bone go apart. The LI4 point will be identified in each patient by asking the patient to adduct the thumb and index finger. The duration will be 5 minutes before LA administration. The administration of local anesthesia in all groups will be achieved by 1.8 ml of 2% Lidocaine with 1/100,000 epinephrine using a 30-gauge long needle | Device | Aculief |
| AudiovisualA dental video story will be presented to the patient using an iPad device connected to a noise cancellation headphone. | Device | dental story |
| TELL SHOW DOThis group will be treated using Tell-show-do technique | Behavioural | TSD |
Primary outcome
Anxiety
Time frame: Will be measured 5 minutes before LA , immediately before extraction and immediately after extraction The total VPT score was obtained by summing the values across all eight panels, with higher scores indicating greater levels of anxiety (range: 0-8).
Anxiety will be measured by A) Pulse oximeter: Pulse oximeter was used to observe the physiological functions like heart rate and SpO₂. B) Venham's picture test: the child was presented with eight different cards. Each card held two pictures-a representation of the child expressing anxiety along with another representation of the same child in a relaxed mood. The child was asked to point out the picture in each pair that resembled how he/she was feeling. There was also an order in which the pictures had to be presented. Assigning the image depicting anxiety the score of 1 and the relaxed image the score of 0 helped in the coding process.
1 secondary outcome
Pain of the patient
Time frame: Will be evaluated immediately after the local anesthesia and tooth extraction using Wong Baker FACES Pain rating scale, ranging from a no pain (score 0) to one showing severe pain (score 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acualief, Audiovisual and TELL SHOW DO in people with Tooth Extraction and Local Anesthesia, run by Mansoura 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 2 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 28 Jan 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?
This study is still under way. Results are not available in the source record yet.
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?
Anxiety (time frame: Will be measured 5 minutes before LA , immediately before extraction and immediately after extraction The total VPT score was obtained by summing the values across all eight panels, with higher scores indicating greater levels of anxiety (range: 0-8).). 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 28 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.