Comparison of Dental Pain Response in Children

Sponsor

Altamash Institute of Dental Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT05883566

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Anxiety	Behavioral: experimental	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Comparison of Behavioral , Physiological and Self-reported Pain Responses in Children With Dental Pain

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: behaviour	Behavioral: experimental 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
No Intervention: control

Arm

Intervention/Treatment

Experimental: behaviour

Behavioral: experimental

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

No Intervention: control

Outcome Measures

Primary Outcome Measures

Post operative pain [immediately after completion of the treatment within 60 seconds]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hira	Karachi	Sindh	Pakistan	7500
2	Hira Danish	Karachi	Sindh	Pakistan	75500

Sponsors and Collaborators

Altamash Institute of Dental Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hira Abbasi, Principle investigator, Altamash Institute of Dental Medicine

ClinicalTrials.gov Identifier:

NCT05883566

Other Study ID Numbers:

Dental Pain in children

First Posted:

Jun 1, 2023

Last Update Posted:

Jun 2, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Toothache

Study Results

No Results Posted as of Jun 2, 2023