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Effect of a Candy Flavoring Before Local Anesthesia on Anxiety and Pain Perception in Children

Sponsor
King Abdullah University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05727527
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
17
Anticipated Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized clinical trial that aims to test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception and anxiety when compared to negative control group. We expect that using the flavor before injecting local anesthesia will distract the child and reduce pain and anxiety.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Local Anesthesia 1
  • Procedure: Local Anesthesia 2
 N/A

Detailed Description

Background: Distraction techniques can be very useful in managing children on the dental chair and to guide their attention away from a painful stimulus. No studies so far have used a sugar-free solution as a distraction method.

Aim: To test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception and anxiety when compared to negative control group, using a split-mouth randomized study design.

Methods: A total of 200 children aged 4-10 years with no previous dental experience and require the same treatment on the upper primary first or second molars bilaterally will be included in this study. The children will be randomly allocated into two groups, group 1 will receive the first injection after applying a flavor, and group 2 will receive the first injection after applying sterile water. The children will receive the first injection on the right or left side and switch sides on the next visit. The observed pain perception will be assessed using the SEM scale. Wong-Baker Faces pain rating scale will be used to assess the pain reported by the child. Pulse rate, BMI, and sweet taste preference will also be recorded by an independent observer to ensure blinding.

Expected results: Using a sugar-free candy flavor before injecting local anesthesia will distract the child and reduce pain and anxiety accompanying local anesthesia.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Using a Sugar-free Candy Flavoring Before Local Anesthesia Injection on Anxiety and Pain Perception in Children: a Split-mouth Randomized Clinical Trial
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Study group

Will initially receive the infiltration injection after applying a candy flavor first, followed by sterile water in the next visit

Procedure: Local Anesthesia 1
Local anesthesia injection after applying a candy flavor

Procedure: Local Anesthesia 2
Local anesthesia injection after applying sterile water
Active Comparator: Control group

Will initially receive the infiltration injection after applying sterile water first, followed by candy flavor in the next visit

Procedure: Local Anesthesia 1
Local anesthesia injection after applying a candy flavor

Procedure: Local Anesthesia 2
Local anesthesia injection after applying sterile water

Outcome Measures

Primary Outcome Measures

  1. Pain score [During injection]

    Reported pain by the child will be assessed using the Wong-Baker FACES Pain Rating Scale

Secondary Outcome Measures

  1. Anxiety [Before and during injection]

    Anxiety will be assessed through pulse rate measurements recorded before, during and the injection using a fingertip pulse oximeter.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Healthy (ASA Grade 1 status) children

  • First dental experience for the child including local anesthesia.

  • Children with caries lesions that require restorative treatment.

  • Children who require the same treatment on upper primary first or second molars bilaterally.

Exclusion Criteria:

  • Children with poor behavior (unable to cooperate for dental treatment).

  • Previous unpleasant dental experience (dental phobia).

  • History of abscess, redness, fistula in the injection site (need for extraction).

  • Presence of a systemic disease, mental, cognitive and intellectual disabilities.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ola B. Al-Batayneh Irbid Jordan 22110

Sponsors and Collaborators

  • King Abdullah University Hospital

Investigators

  • Principal Investigator: Ola B. Al-Batayneh, Jordan University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
King Abdullah University Hospital
ClinicalTrials.gov Identifier:
NCT05727527
Other Study ID Numbers:
  • 692l2021
First Posted:
Feb 14, 2023
Last Update Posted:
Feb 14, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anesthetics

Study Results

No Results Posted as of Feb 14, 2023