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

Anxiety Clinical Trial

Official title:

Mobile App (Little Lovely Dentist) Versus Tell-Show-Do Technique in Reduction of Anxiety and Pain During Administration of Local Anaesthesia in Children (A Randomized Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04731181
• Other study ID #: mobile app in dentistry
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention group: mobile application (little lovely dentist) control group: Tell-Show-Do technique. in children aged 4-6 years who need local anesthesia for dental treatment during their first dental visit.

For both groups:

Verbal assent from participating patients and written consent from their legal guardians will be taken.

1. Taking personal data, medical and dental history.

2. Diagnosis and determination of the required treatment.

3. Measuring preoperative anxiety using a pulse oximeter.

4. Evaluate preoperative anxiety using RMS-pictorial scale.

5. Using the behavior guidance technique:

Intervention group: Allow the child to play the module simulating the required procedure. Control group: tell-show-do technique is used to explain the procedure to the child

6. Administration of local anesthesia and evaluation of child behaviour during the administration of local anaesthesia using Venham's behaviour rating scale and Frankl behaviour rating scale .

7. Measuring postoperative anxiety using the pulse oximeter.

8. Evaluate postoperative anxiety using RMS-pictorial scale.

9. Evaluate postoperative pain using the visual analog scale.

in second visit (after 1 week)

1) Evaluation of child behavior during the second dental visit using Venham's behavior rating scale and Frankl behavior rating scale. outcome:

1. ry: Pre and postoperative anxiety using Pulse oximeter and RMS-pictorial scale.

2. ry: Postoperative pain using Visual analog scale, evaluation of attitude during the administration of local anaesthesia at first and second dental visits using -Venham's behavior rating scale-Frankl behavior rating scale. the study will be held in 2 visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• mobile application (little lovely dentist).
mobile application

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

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

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. — View Citation

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.pu — View Citation

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. Ep — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Postoperative pain	Postoperative pain will be measured immediately after administration of local anesthesia by the visual analog scale in a numerical unit 0-10 where 0 denotes no pain and 10 denotes the worst pain	immediately after administration of local anesthesia during the first dental visit
Secondary	Attitude during the first and second dental visits using frankle behavior rating scale	evaluation of child behavior during the first and second visits using frankle behavior rating scale in a numerical unit rating 1-4 where,; Definitely Negative: Refusal of treatment, crying forcefully, fearful, or any other overt evidence of extreme negativism.; Negative: Reluctant to accept treatment, uncooperative, some evidence of negative attitude but not pronounced withdrawn.; Positive: Acceptance of treatment; at times curious, willing to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively; Definitely positive: Good rapport with the dentist, interested in dental procedures, and laughing and enjoying the situation.	during administration of local anasthesia during the the first and second dental visits (after 1 week)
Secondary	Attitude during the first and second dental visits using Venham's behavior rating scale	evaluation of child behavior during the first and second visits using Venham's behavior rating scale in a numerical unit using score 0-3 where, 0- Total cooperation, best working conditions, no crying, or physical protest.; Mild, soft verbal protest or quiet crying as a signal of discomfort, but doesn't obstruct progress. Appropriate behavior for the procedure.; Protest more prominent. Both crying and hand signals. May move head around making it hard to perform the treatment. Protest more distracting and troublesome. However, the child still complies with the request to cooperate.; Protest presents a real problem to the dentist. Complies with demands reluctantly, requiring more effort by dentist + Body movement.	during administration of local anasthesia during the first and second dental visits (after 1 week)