Effectiveness of Mobile Applications During the Administration of Local Anesthesia in Pediatric Dentistry

NCT04731181 | Completed

• 1 other identifier: mobile app in dentistry
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the mobile games' effect on patient acceptance of local anesthesia and decreasing dental pain and anxiety levels in pediatric patients.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (4)

• Preoperative anxiety

  Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter (IMDK) in beat per minute unit (BPM)

  before administration of local anesthesia during the first dental visit

• postoperative anxiety

  postoperative anxiety will be measured immediately after administration of local anesthesia using a fingertip pulse oximeter (IMDK) in beat per minute unit (BPM)

  immediately after administration of local anesthesia during the first dental visit

• Preoperative anxiety score

  will be assessed by RMS-pictorial scale ( Raghavendra, Madhuri, Sujata - pictorial scale) before administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety

  before administration of local anesthesia during the first dental visit

• post-operative anxiety score

  will be assessed by RMS-pictorial scale ( Raghavendra, Madhuri, Sujata - pictorial scale) immediately after administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety

  immediately after administration of local anesthesia during the first dental visit

Secondary Outcomes (3)

• Postoperative pain

  immediately after administration of local anesthesia during the first dental visit

• Attitude during the first and second dental visits using frankle behavior rating scale

  during administration of local anasthesia during the the first and second dental visits (after 1 week)

• Attitude during the first and second dental visits using Venham's behavior rating scale

  during administration of local anasthesia during the first and second dental visits (after 1 week)

Study Arms (2)

mobile application (little lovely dentist).

EXPERIMENTAL

intervention mobile application simulating the dental procedure that will be done to the child

Behavioral: mobile application (little lovely dentist).

Tell-Show-Do technique.

NO INTERVENTION

control behavior technique where ''tell'' is to tell the child about the procedure in non-threatening words, ''show'' is to demonstrate the procedure to the child, and ''do'' is the execution of the procedure

Interventions

mobile application (little lovely dentist). BEHAVIORAL

mobile application

mobile application (little lovely dentist).

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4-6 years.
• Children without any systemic or mental disorders.
• Children without any prior experience with the dental environment or treatment procedures (first dental visit).
• Children whose behavior could be rated as positive or negative based on the Frankl behavior rating scale.

You may not qualify if:

• Children seeking dental treatment that does not necessitate local anesthesia.
• Children suffering from any systemic or mental disorders.
• Children who are not willing to participate in the study

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, Egypt

Location

Related Publications (9)

• Steimer T. The biology of fear- and anxiety-related behaviors. Dialogues Clin Neurosci. 2002 Sep;4(3):231-49. doi: 10.31887/DCNS.2002.4.3/tsteimer.

  PMID: 22033741 RESULT

• Saatchi M, Abtahi M, Mohammadi G, Mirdamadi M, Binandeh ES. The prevalence of dental anxiety and fear in patients referred to Isfahan Dental School, Iran. Dent Res J (Isfahan). 2015 May-Jun;12(3):248-53.

  PMID: 26005465 RESULT

• Shim YS, Kim AH, Jeon EY, An SY. Dental fear & anxiety and dental pain in children and adolescents; a systemic review. J Dent Anesth Pain Med. 2015 Jun;15(2):53-61. doi: 10.17245/jdapm.2015.15.2.53. Epub 2015 Jun 30.

  PMID: 28879259 RESULT

• Ghanei M, Arnrup K, Robertson A. Procedural pain in routine dental care for children: a part of the Swedish BITA study. Eur Arch Paediatr Dent. 2018 Oct;19(5):365-372. doi: 10.1007/s40368-018-0368-2. Epub 2018 Sep 7.

  PMID: 30194611 RESULT

• Shetty RM, Khandelwal M, Rath S. RMS Pictorial Scale (RMS-PS): an innovative scale for the assessment of child's dental anxiety. J Indian Soc Pedod Prev Dent. 2015 Jan-Mar;33(1):48-52. doi: 10.4103/0970-4388.149006.

  PMID: 25572374 RESULT

• Monteiro J, Tanday A, Ashley PF, Parekh S, Alamri H. Interventions for increasing acceptance of local anaesthetic in children and adolescents having dental treatment. Cochrane Database Syst Rev. 2020 Feb 27;2(2):CD011024. doi: 10.1002/14651858.CD011024.pub2.

  PMID: 32104910 RESULT

• Saxena P, Gupta SK, Newaskar V, Chandra A. Advances in dental local anesthesia techniques and devices: An update. Natl J Maxillofac Surg. 2013 Jan;4(1):19-24. doi: 10.4103/0975-5950.117873.

  PMID: 24163548 RESULT

• Behavior Guidance for the Pediatric Dental Patient. Pediatr Dent. 2017 Sep 15;39(6):246-259. No abstract available.

  PMID: 29179365 RESULT

• Radhakrishna S, Srinivasan I, Setty JV, D R MK, Melwani A, Hegde KM. Comparison of three behavior modification techniques for management of anxious children aged 4-8 years. J Dent Anesth Pain Med. 2019 Feb;19(1):29-36. doi: 10.17245/jdapm.2019.19.1.29. Epub 2019 Feb 28.

  PMID: 30859131 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Passant Nagi, PHD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: parallel-group and allocation ratio (1:1) Intervention: mobile application (little lovely dentist). Control: Tell-Show-Do technique.

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 29, 2021
• Study Start: October 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

EG (1)