Behavior ManagementNCT07770321
Effect of Audio-analgesia Using Binaural Beats and Instrumental Music on the Behaviour of Minimally Sedated Pediatric Patients
A study testing Audio analgesia, 0.3 mg/kg midazolam and 0.5 mg/kg midazolam in people with Behavior Management, run by Rania Ahmedien at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of audio analgesia (using binaural beats and instrumental music) in conjunction with a minimal dose of intranasal aerosolized midazolam on acquiring satisfactory patient cooperation. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Behavior Management
- What is being tested?
- Audio analgesia, 0.3 mg/kg midazolam and 0.5 mg/kg midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2025to 6 Apr 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Frankl scale score 1 or 2 (Definitely Negative or Negative behavior)
- American Society of Anesthesiologist I, II physical status (ASA I, II)
- Patient presenting with at least one primary molar indicated for extraction.
- Parent/guardian written consent.
Who cannot join
- Medically compromised patients.
- Cognitively impaired patients.
- Hearing disabilities.
- Mouth breathers.
- Hypersensitivity to local anesthetic drugs used.
- Patients with known allergy to midazolam.
- Teeth with ankylosed roots
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Audio-analgesia Using Binaural Beats and Instrumental Music on the Behaviour of Minimally Sedated Pediatric Patients: A Randomized Controlled Clinical Trial
The aim of this study is to evaluate the effect of audio analgesia (using binaural beats and instrumental music) in conjunction with a minimal dose of intranasal aerosolized midazolam on acquiring satisfactory patient cooperation.
- Conditions
- Behavior Management
- Being tested
- Audio analgesia, 0.3 mg/kg midazolam, 0.5 mg/kg midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio analgesiaOther
Patients received a procedural sedation session using audio analgesia using binaural beats and instrumental music
0.3 mg/kg midazolamDrug
Patients received a procedural sedation session, using aerosolized solution of 0.3 mg/kg Midazolam
0.5 mg/kg midazolamDrug
Patients received a procedural sedation session, using aerosolized solution of 0.5 mg/kg Midazolam
| Study group | Role | What they receive |
|---|---|---|
| 0.3 mg/kg aerosolized midazolam + audio analgesia | Experimental | Not described Receives: Other: Audio analgesia; Drug: 0.3 mg/kg midazolam |
| 0.3 mg/kg aerosolized midazolam | Experimental | Not described Receives: Drug: 0.3 mg/kg midazolam |
| 0.5 mg/kg aerosolized midazolam | Active comparator | Not described Receives: Drug: 0.5 mg/kg midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of treatment completion
The ease of treatment completion was measured using a five point scale (1-5) with higher scores indicating easier treatment
Measured: throughout the procedure completion
Child's dental anxiety
It was assessed using Venham's Clinical Anxiety Scale with scores ranging 0 (best) to 5 (worst)
Measured: throughout the procedure completion
Secondary outcomes (6)
Analgesic effect
It was assessed using the FLACC scale. The scale is scored in a range of 0-10 with 0 representing no pain.
Measured: throughout the procedure completion
Sedation Depth
The sedation depth was assessed by the Richmond Agitation Sedation Scale with scores ranging from -5 to +4, with lower scores indicating deeper sedation
Measured: throughout the procedure completion
Parental satisfaction
The parents/guardians will be asked to rate their overall satisfaction with care under sedation by using a simple image of 5 point Likert scale with higher scores indicating greater satisfaction
Measured: throughout the procedure completion
Oxygen saturation
Measured: From enrollment and throughout procedure completion
Heart rate
Measured: From enrollment and throughout procedure completion
Blood pressure
Measured: From enrollment and throughout procedure completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start12 Oct 2025
- Primary completion6 Apr 2026
- Study completion6 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior ManagementStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rania Ahmedien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rania Ahmedien, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770321
- Sponsor's protocol ID
- 1097-06-2025
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 18 Aug 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Audio-analgesia Using Binaural Beats and Instrumental Music on the Behaviour of Minimally Sedated Pediatric Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07770321
- Acronym / sponsor ID
- 1097-06-2025
- Conditions
- Behavior Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Rania AhmedienUniversity, hospital or other
- Study start
- 12 Oct 2025 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 18 Aug 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 effect of audio analgesia (using binaural beats and instrumental music) in conjunction with a minimal dose of intranasal aerosolized midazolam on acquiring satisfactory patient cooperation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.3 mg/kg aerosolized midazolam + audio analgesia | Experimental | Other: Audio analgesia, Drug: 0.3 mg/kg midazolam |
| 0.3 mg/kg aerosolized midazolam | Experimental | Drug: 0.3 mg/kg midazolam |
| 0.5 mg/kg aerosolized midazolam | Active comparator | Drug: 0.5 mg/kg midazolam |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Frankl scale score 1 or 2 (Definitely Negative or Negative behavior)
- American Society of Anesthesiologist I, II physical status (ASA I, II)
- Patient presenting with at least one primary molar indicated for extraction.
- Parent/guardian written consent.
Key exclusion criteria (7 listed)
- Medically compromised patients.
- Cognitively impaired patients.
- Hearing disabilities.
- Mouth breathers.
- Hypersensitivity to local anesthetic drugs used.
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 |
|---|---|---|
| Audio analgesiaPatients received a procedural sedation session using audio analgesia using binaural beats and instrumental music | Other | 0.3 mg/kg aerosolized midazolam + audio analgesia |
| 0.3 mg/kg midazolamPatients received a procedural sedation session, using aerosolized solution of 0.3 mg/kg Midazolam | Drug | 0.3 mg/kg aerosolized midazolam, 0.3 mg/kg aerosolized midazolam + audio analgesia |
| 0.5 mg/kg midazolamPatients received a procedural sedation session, using aerosolized solution of 0.5 mg/kg Midazolam | Drug | 0.5 mg/kg aerosolized midazolam |
Primary outcome
Ease of treatment completion
Time frame: throughout the procedure completion
The ease of treatment completion was measured using a five point scale (1-5) with higher scores indicating easier treatment
Child's dental anxiety
Time frame: throughout the procedure completion
It was assessed using Venham's Clinical Anxiety Scale with scores ranging 0 (best) to 5 (worst)
6 secondary outcomes
Analgesic effect
Time frame: throughout the procedure completion
Sedation Depth
Time frame: throughout the procedure completion
Parental satisfaction
Time frame: throughout the procedure completion
Oxygen saturation
Time frame: From enrollment and throughout procedure completion
Heart rate
Time frame: From enrollment and throughout procedure completion
Blood pressure
Time frame: From enrollment and throughout procedure completion
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 18 Aug 2026.
Related trials for Behavior Management
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
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.
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 Audio analgesia, 0.3 mg/kg midazolam and 0.5 mg/kg midazolam in people with Behavior Management, run by Rania Ahmedien 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 7 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 18 Aug 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?
Ease of treatment completion (time frame: throughout the procedure completion). The study lists 2 primary outcomes in all. 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 18 Aug 2026.