Clinical trial NCT04731181: Effectiveness of Mobile Applications During the Administration of Local Anesthesia in Pediatric Dentistry
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel-group and allocation ratio (1:1) Intervention: mobile application (little lovely dentist). Control: Tell-Show-Do technique.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Preoperative anxiety
timeFrame: before administration of local anesthesia during the first dental visit
measure: postoperative anxiety
timeFrame: immediately after administration of local anesthesia during the first dental visit
measure: Preoperative anxiety score
timeFrame: before administration of local anesthesia during the first dental visit
measure: post-operative anxiety score
timeFrame: immediately after administration of local anesthesia during the first dental visit
Secondary outcomes:
measure: Postoperative pain
timeFrame: immediately after administration of local anesthesia during the first dental visit
measure: Attitude during the first and second dental visits using frankle behavior rating scale
timeFrame: during administration of local anasthesia during the the first and second dental visits (after 1 week)
measure: Attitude during the first and second dental visits using Venham's behavior rating scale
timeFrame: during administration of local anasthesia during the first and second dental visits (after 1 week)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry - Cairo University
Study officials:
affiliation: Cairo University
name: Passant Nagi, PHD
role: STUDY_DIRECTOR
References:
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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.pub2.
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