NCT05883566

Brief Summary

Study involves the observation of the child's behavior during a dental treatment procedure. This allows for the evaluation of the child's experience of pain and discomfort through their facial expressions, body movements, and vocalizations during the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

May 21, 2023

Last Update Submit

September 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post operative pain

    Analysis of pain after the treatment pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured

    immediately after completion of the treatment within 60 seconds

Study Arms (2)

behaviour

EXPERIMENTAL
Behavioral: experimental

control

NO INTERVENTION

Interventions

experimentalBEHAVIORAL

During the procedure, the chairside assistant can capture video recordings of the child's behavior and facial expressions. These videos can be later reviewed by a trained observer who can evaluate the child's pain experience

behaviour

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age range: Children aged between 6-12 years old (or any other specific age range) will be included in the study.
  • Dental pain: Participants who have been diagnosed with dental pain by their dentist will be included.
  • Consent: Informed consent must be obtained from the child and their parents or guardians before the study.

You may not qualify if:

  • Participants with existing medical or psychological conditions that could affect the pain response for instance, children with chronic pain conditions or with a history of anxiety or depression.
  • Participants who have taken any pain medication within the past 24 hours as this could interfere with the pain response.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hira

Karachi, Sindh, 7500, Pakistan

Location

Hira Danish

Karachi, Sindh, 75500, Pakistan

Location

Related Publications (1)

  • Abbasi H, Saini RS, Binduhayyim RIH, Kuruniyan MS, Mosaddad SA, Heboyan A. Comparison of behavioural, physiological, and self-reported pain responses in Pakistani children with dental pain: a descriptive cross-sectional study. Eur Arch Paediatr Dent. 2025 Dec;26(6):1181-1192. doi: 10.1007/s40368-025-01090-x. Epub 2025 Aug 3.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

May 21, 2023

First Posted

June 1, 2023

Study Start

May 1, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations