NCT07740525

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 17, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 17, 2026

Last Update Submit

July 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Heart rate

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

    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.

    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.

Study Arms (2)

Audiovisual aids

EXPERIMENTAL
Behavioral: Audiovisual Aids

Parental Presence

ACTIVE COMPARATOR
Behavioral: Parental Presence

Interventions

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

Audiovisual aids

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

Parental Presence

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 4-11 years
  • Requiring restorative treatment
  • ASA I and II

You may not qualify if:

  • Children with special healthcare needs Emergency dental treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Operative dentistry department,PIMS

Islamabad, Federal, Pakistan

RECRUITING

MeSH Terms

Interventions

Audiovisual Aids

Intervention Hierarchy (Ancestors)

Educational TechnologyTechnologyTechnology, Industry, and Agriculture

Central Study Contacts

Ajwa Ismail, MDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-Graduate Resident

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 31, 2026

Study Start

June 5, 2026

Primary Completion

July 31, 2026

Study Completion

July 31, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations