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

May 3, 2024 updated by: King Abdullah University Hospital

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

This is a randomized clinical trial that aimed to test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception when compared to a negative control group. Applying the flavor before injecting local anesthesia helped in distracting the child and reduced the associated pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 84 children, aged 4-9 years with no previous dental experience and require the same treatment on the upper primary first or second molars bilaterally were included in this study. Each child received two injections. The children were randomly allocated into two groups, group 1 received the first injection after applying a flavor, and group 2 received the first injection after applying sterile water. The children received the first injection either on the right or left side, and switched sides on the next visit, resulting in (n=168) total injections. The observed pain perception was 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 were also recorded by an independent observer to ensure blinding.

Results: Using a sugar-free candy flavor before injecting local anesthesia helps in reducing pain accompanying local anesthesia.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 22110
        • Ola B. Al-Batayneh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: During injection
Reported pain by the child will be assessed using the Wong-Baker Faces Pain Rating Scale, Scores range from 0-10, higher scores mean more pain
During injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Before and during injection
Anxiety will be assessed through pulse rate measurements recorded before, during and the injection using a fingertip pulse oximeter.
Before and during injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

February 5, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 692l2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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