Effect of a Candy Flavoring Before Local Anesthesia on Anxiety and Pain Perception in Children
NCT ID: NCT05727527
Last Updated: 2024-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2022-04-01
2023-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Study group
Will initially receive the infiltration injection after applying a candy flavor first, followed by sterile water in the next visit
Local Anesthesia 1
Local anesthesia injection after applying a candy flavor
Local Anesthesia 2
Local anesthesia injection after applying sterile water
Control group
Will initially receive the infiltration injection after applying sterile water first, followed by candy flavor in the next visit
Local Anesthesia 1
Local anesthesia injection after applying a candy flavor
Local Anesthesia 2
Local anesthesia injection after applying sterile water
Interventions
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Local Anesthesia 1
Local anesthesia injection after applying a candy flavor
Local Anesthesia 2
Local anesthesia injection after applying sterile water
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
4 Years
10 Years
ALL
Yes
Sponsors
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King Abdullah University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ola B. Al-Batayneh
Role: PRINCIPAL_INVESTIGATOR
Jordan University of Science and Technology
Locations
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Ola B. Al-Batayneh
Irbid, , Jordan
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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692l2021
Identifier Type: -
Identifier Source: org_study_id
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