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To evaluate the mobile games' effect on patient acceptance of local anesthesia and decreasing dental pain and anxiety levels in pediatric patients.
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.
Taking personal data, medical and dental history.
Diagnosis and determination of the required treatment.
Measuring preoperative anxiety using a pulse oximeter.
Evaluate preoperative anxiety using RMS-pictorial scale.
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
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 .
Measuring postoperative anxiety using the pulse oximeter.
Evaluate postoperative anxiety using RMS-pictorial scale.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mobile application (little lovely dentist). | Experimental | intervention mobile application simulating the dental procedure that will be done to the child |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile application (little lovely dentist). | Behavioral | mobile application |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Attitude during the first and second dental visits using frankle behavior rating scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Passant Nagi, PHD | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry - Cairo University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22033741 | Result | 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. | |
| 26005465 | 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. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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parallel-group and allocation ratio (1:1) Intervention: mobile application (little lovely dentist). Control: Tell-Show-Do technique.
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evaluation of child behavior during the first and second visits using frankle behavior rating scale in a numerical unit rating 1-4 where,
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) |
| 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.
| during administration of local anasthesia during the first and second dental visits (after 1 week) |
| 28879259 | 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. |
| 30194611 | 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. |
| 25572374 | 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. |
| 32104910 | 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. |
| 24163548 | 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. |
| 29179365 | Result | Behavior Guidance for the Pediatric Dental Patient. Pediatr Dent. 2017 Sep 15;39(6):246-259. No abstract available. |
| 30859131 | 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. |