Evaluation of Audiovisual Aids and Parental Presence for Anxiety Reduction in Pediatric Dental Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-11
SponsorPakistan Institute of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 4-11 years

Requiring restorative treatment

ASA I and II

Disqualifiers

Children with special healthcare needs Emergency dental treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Audiovisual Aids

    Behavioral

    Children receive audiovisual distraction for example cartoons during procedure to reduce dental anxiety.

  • Parental Presence

    Behavioral

    One parent will remain present with the child during procedure for reassurance and reduce anxiety

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Audiovisual aidsExperimental treatment 1 intervention
Group B: Parental PresenceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Heart rate

Heart rate (beats per minute) will be measured using a pulse oximeter to assess physiological anxiety during dental treatment.

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
2

Oxygen Saturation

Oxygen Saturation (SpO2, %) will be measured using a pulse oximeter to assess physiological changes associated with dental anxiety during dental treatment.

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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