Anxiety in ChildrenNCT07740525
Evaluation of Audiovisual Aids and Parental Presence for Anxiety Reduction in Pediatric Dental Patients
A study testing Audiovisual Aids and Parental Presence in people with Anxiety in Children, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
This randomized control trial aims to compare the effectiveness of audiovisual distraction and parental presence in reducing dental anxiety among pediatric patients ongoing treatment. Anxiety will be measured using validated behavioral and physiological measures. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Anxiety in Children
- What is being tested?
- Audiovisual Aids and Parental Presence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jun 2026to 31 Jul 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4-11 years
- Requiring restorative treatment
- ASA I and II
Who cannot join
- Children with special healthcare needs Emergency dental treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Operative dentistry department,PIMS
Islamabad, Federal
Ajwa Ismail, MDS, +923100571531, ajwa1009@gmail.com
Ajwa Ismail, MDS, ajwa1009@gmail.com
About this study
Official title: Effectiveness of Behavior Modification Techniques on Anxiety Reduction in Pediatric Patients: Audiovisual Aids and Parental Presence Comparison
This randomized control trial aims to compare the effectiveness of audiovisual distraction and parental presence in reducing dental anxiety among pediatric patients ongoing treatment. Anxiety will be measured using validated behavioral and physiological measures.
- Conditions
- Anxiety in Children
- Being tested
- Audiovisual Aids, Parental Presence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual AidsBehavioural
Children receive audiovisual distraction for example cartoons during procedure to reduce dental anxiety.
Parental PresenceBehavioural
One parent will remain present with the child during procedure for reassurance and reduce anxiety
| Study group | Role | What they receive |
|---|---|---|
| Audiovisual aids | Experimental | Not described Receives: Behavioral: Audiovisual Aids |
| Parental Presence | Active comparator | Not described Receives: Behavioral: Parental Presence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate (beats per minute) will be measured using a pulse oximeter to assess physiological anxiety during dental treatment.
Measured: At Visit 1: Heart rate will be measured before the procedure, during the procedure, and immediately after the procedure At Visit 2: Heart rate will be measured before the procedure, during the procedure, and immediately after the procedure
Oxygen Saturation
Oxygen Saturation (SpO2, %) will be measured using a pulse oximeter to assess physiological changes associated with dental anxiety during dental treatment.
Measured: Oxygen Saturation will be measured At Visit 1: before the procedure, during the procedure, and immediately after the procedure. At Visit 2: before the procedure, during the procedure, and immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start5 Jun 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety in ChildrenStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ajwa Ismail, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740525
- Sponsor's protocol ID
- F-5-2/2024(ERRC)/26th-PIMS
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Behavior Modification Techniques on Anxiety Reduction in Pediatric Patients: Audiovisual Aids and Parental Presence Comparison
- ClinicalTrials.gov ID
- NCT07740525
- Acronym / sponsor ID
- F-5-2/2024(ERRC)/26th-PIMS
- Conditions
- Anxiety in Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 31 Jul 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.
This randomized control trial aims to compare the effectiveness of audiovisual distraction and parental presence in reducing dental anxiety among pediatric patients ongoing treatment. Anxiety will be measured using validated behavioral and physiological measures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audiovisual aids | Experimental | Behavioral: Audiovisual Aids |
| Parental Presence | Active comparator | Behavioral: Parental Presence |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 4-11 years
- Requiring restorative treatment
- ASA I and II
Key exclusion criteria (1 listed)
- Children with special healthcare needs Emergency dental 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 |
|---|---|---|
| Audiovisual AidsChildren receive audiovisual distraction for example cartoons during procedure to reduce dental anxiety. | Behavioural | Audiovisual aids |
| Parental PresenceOne parent will remain present with the child during procedure for reassurance and reduce anxiety | Behavioural | Parental Presence |
Primary outcome
Heart rate
Time frame: At Visit 1: Heart rate will be measured before the procedure, during the procedure, and immediately after the procedure At Visit 2: Heart rate will be measured before the procedure, during the procedure, and immediately after the procedure
Heart rate (beats per minute) will be measured using a pulse oximeter to assess physiological anxiety during dental treatment.
Oxygen Saturation
Time frame: Oxygen Saturation will be measured At Visit 1: before the procedure, during the procedure, and immediately after the procedure. At Visit 2: before the procedure, during the procedure, and immediately after the procedure.
Oxygen Saturation (SpO2, %) will be measured using a pulse oximeter to assess physiological changes associated with dental anxiety during dental treatment.
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 31 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual Aids and Parental Presence in people with Anxiety in Children, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 3 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: looking for participants now, as of the sponsor's last update on 31 Jul 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 Pakistan. 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?
Contact Ajwa Ismail, MDS (+923100571531, ajwa1009@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: At Visit 1: Heart rate will be measured before the procedure, during the procedure, and immediately after the procedure At Visit 2: Heart rate will be measured before the procedure, during the procedure, and immediately after the procedure). 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 31 Jul 2026.