Back to resultsComparison of Dental Pain Response in Children
Primary Purpose
Dental Anxiety
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
experimental
Sponsored by
About this trial
This is an interventional supportive care trial for Dental Anxiety
Eligibility Criteria
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.
Sites / Locations
- Hira
- Hira Danish
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
behaviour
control
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05883566
First Posted
May 21, 2023
Last Updated
September 8, 2023
Sponsor
Altamash Institute of Dental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05883566
Brief Title
Comparison of Dental Pain Response in Children
Official Title
Comparison of Behavioral , Physiological and Self-reported Pain Responses in Children With Dental Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Altamash Institute of Dental Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
behaviour
Arm Type
Experimental
Arm Title
control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
experimental
Intervention Description
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
Primary Outcome Measure Information:
Title
Post operative pain
Description
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
Time Frame
immediately after completion of the treatment within 60 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hira
City
Karachi
State/Province
Sindh
ZIP/Postal Code
7500
Country
Pakistan
Facility Name
Hira Danish
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75500
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Dental Pain Response in Children
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