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

NCT05727527 | Completed

• 1 other identifier: 692l2021
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Local Anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain score

  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 Outcomes (1)

• Anxiety

  Before and during injection

Study Arms (2)

Study group

ACTIVE COMPARATOR

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

Procedure: Local Anesthesia 1; Procedure: Local Anesthesia 2

Control group

ACTIVE COMPARATOR

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

Procedure: Local Anesthesia 1; Procedure: Local Anesthesia 2

Interventions

Local Anesthesia 1 PROCEDURE

Local anesthesia injection after applying a candy flavor

Control group; Study group

Local Anesthesia 2 PROCEDURE

Local anesthesia injection after applying sterile water

Control group; Study group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah University Hospital: lead

Study Sites (1)

Ola B. Al-Batayneh

Irbid, 22110, Jordan

Location

Related Publications (9)

• Alanazi KJ, Pani S, AlGhanim N. Efficacy of external cold and a vibrating device in reducing discomfort of dental injections in children: A split mouth randomised crossover study. Eur Arch Paediatr Dent. 2019 Apr;20(2):79-84. doi: 10.1007/s40368-018-0399-8. Epub 2018 Dec 5.

  PMID: 30519955 BACKGROUND

• Al-Khotani A, Bello LA, Christidis N. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial. Acta Odontol Scand. 2016 Aug;74(6):494-501. doi: 10.1080/00016357.2016.1206211. Epub 2016 Jul 13.

  PMID: 27409593 BACKGROUND

• Asvanund Y, Mitrakul K, Juhong RO, Arunakul M. Effect of audiovisual eyeglasses during local anesthesia injections in 5- to 8-year-old children. Quintessence Int. 2015 Jun;46(6):513-21. doi: 10.3290/j.qi.a33932.

  PMID: 25918755 BACKGROUND

• Ghaderi F, Ahmadbeigi M, Vossoughi M, Sardarian A. The efficacy of administrating a sweet-tasting solution for reducing the pain related to dental injections in children: A randomized controlled trial. Int J Paediatr Dent. 2021 Mar;31(2):184-190. doi: 10.1111/ipd.12697. Epub 2020 Aug 25.

  PMID: 32757418 BACKGROUND

• Ghadimi S, Estaki Z, Rahbar P, Shamshiri AR. Effect of visual distraction on children's anxiety during dental treatment: a crossover randomized clinical trial. Eur Arch Paediatr Dent. 2018 Aug;19(4):239-244. doi: 10.1007/s40368-018-0352-x. Epub 2018 Jun 12.

  PMID: 29949082 BACKGROUND

• Jones CM, Heidmann J, Gerrish AC. Children's ratings of dental injection and treatment pain, and the influence of the time taken to administer the injection. Int J Paediatr Dent. 1995 Jun;5(2):81-5. doi: 10.1111/j.1365-263x.1995.tb00169.x.

  PMID: 7547818 BACKGROUND

• Nuvvula S, Alahari S, Kamatham R, Challa RR. Effect of audiovisual distraction with 3D video glasses on dental anxiety of children experiencing administration of local analgesia: a randomised clinical trial. Eur Arch Paediatr Dent. 2015 Feb;16(1):43-50. doi: 10.1007/s40368-014-0145-9. Epub 2014 Sep 26.

  PMID: 25256207 BACKGROUND

• Srouji R, Ratnapalan S, Schneeweiss S. Pain in children: assessment and nonpharmacological management. Int J Pediatr. 2010;2010:474838. doi: 10.1155/2010/474838. Epub 2010 Jul 25.

  PMID: 20706640 BACKGROUND

• Pepino YM, Mennella JA. Sucrose-induced analgesia is related to sweet preferences in children but not adults. Pain. 2005 Dec 15;119(1-3):210-218. doi: 10.1016/j.pain.2005.09.029. Epub 2005 Nov 18.

  PMID: 16298489 BACKGROUND

Study Officials

• Ola B. Al-Batayneh

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 14, 2023
• Study Start: April 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

JO (1)