Comparison of Dental Pain Response in Children
Comparison of Behavioral , Physiological and Self-reported Pain Responses in Children With Dental Pain
1 other identifier
interventional
30
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2023
Shorter than P25 for not_applicable
2 active sites
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
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 21, 2023
CompletedFirst Posted
Study publicly available on registry
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedSeptember 11, 2023
September 1, 2023
2 months
May 21, 2023
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
EXPERIMENTALcontrol
NO INTERVENTIONInterventions
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
Eligibility Criteria
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
Hira Danish
Karachi, Sindh, 75500, Pakistan
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.
PMID: 40753526DERIVED
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