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

Primary Purpose

Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mobile application (little lovely dentist).
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anxiety

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Dentistry - Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mobile application (little lovely dentist).

Tell-Show-Do technique.

Arm Description

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

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

Outcomes

Primary Outcome Measures

Preoperative anxiety
Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter (IMDK) in beat per minute unit (BPM)
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)
Preoperative anxiety score
will be assessed by RMS-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial 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
post-operative anxiety score
will be assessed by RMS-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial 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

Secondary Outcome Measures

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
Attitude during the second dental visit using frankle behavior rating scale
evaluation of child behavior during the second visit 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.
Attitude during the second dental visit using Venham's behavior rating scale
evaluation of child behavior during the second visit 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.

Full Information

First Posted
January 19, 2021
Last Updated
September 1, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04731181
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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-pectorial 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 6) Administration of local anesthesia with the observation of intraoperative signs of pain or anxiety. 7) Measuring postoperative anxiety using the pulse oximeter. 8) Evaluate postoperative anxiety using RMS-pectorial scale. 9) Evaluate postoperative pain using the visual analog scale. 10) Asking the child and the parent about satisfaction. 11) Evaluation of child behavior during the second dental visit using Venham's behavior rating scale and Frankl behavior rating scale. outcome: ry: Pre and postoperative anxiety using Pulse oximeter and RMS-pectorial scale. ry: Postoperative pain using Visual analog scale, Intraoperative assessment of pain and anxiety by Observing the child, Child satisfaction by asking the child, Parent satisfaction by asking the parent, Completion of treatment and Attitude during the second dental visit using -Venham's behavior rating scale-Frankl behavior rating scale. the study will be held in 2 visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel-group and allocation ratio (1:1) Intervention: mobile application (little lovely dentist). Control: Tell-Show-Do technique.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mobile application (little lovely dentist).
Arm Type
Experimental
Arm Description
intervention mobile application simulating the dental procedure that will be done to the child
Arm Title
Tell-Show-Do technique.
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
mobile application (little lovely dentist).
Intervention Description
mobile application
Primary Outcome Measure Information:
Title
Preoperative anxiety
Description
Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter (IMDK) in beat per minute unit (BPM)
Time Frame
before administration of local anesthesia during the first dental visit
Title
postoperative anxiety
Description
postoperative anxiety will be measured immediately after administration of local anesthesia using a fingertip pulse oximeter (IMDK) in beat per minute unit (BPM)
Time Frame
immediately after administration of local anesthesia during the first dental visit
Title
Preoperative anxiety score
Description
will be assessed by RMS-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial 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
Time Frame
before administration of local anesthesia during the first dental visit
Title
post-operative anxiety score
Description
will be assessed by RMS-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial 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
Time Frame
immediately after administration of local anesthesia during the first dental visit
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
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
Time Frame
immediately after administration of local anesthesia during the first dental visit
Title
Attitude during the second dental visit using frankle behavior rating scale
Description
evaluation of child behavior during the second visit 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.
Time Frame
during administration of local anasthesia during the second dental visit (after 1 week)
Title
Attitude during the second dental visit using Venham's behavior rating scale
Description
evaluation of child behavior during the second visit 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.
Time Frame
during administration of local anasthesia during the second dental visit (after 1 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marian Mamdouh, Master's
Phone
+20 01287231534
Email
marian.mamdouh@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Passant Nagi, PHD
Phone
+20 1280557107
Email
lpassant.nagi@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Passant Nagi, PHD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry - Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
marian mamdouh, master
Phone
01287231534
Email
marian.mamdouh@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
passant nagi, PHD
Phone
01280557107
Email
passant.nagi@dentistry.cu.edu.eg

12. IPD Sharing Statement

Citations:
PubMed Identifier
22033741
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.
Results Reference
result
PubMed Identifier
26005465
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.
Results Reference
result
PubMed Identifier
28879259
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.
Results Reference
result
PubMed Identifier
30194611
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.
Results Reference
result
PubMed Identifier
25572374
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.
Results Reference
result
PubMed Identifier
32104910
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.
Results Reference
result
PubMed Identifier
24163548
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.
Results Reference
result
PubMed Identifier
29179365
Citation
Behavior Guidance for the Pediatric Dental Patient. Pediatr Dent. 2017 Sep 15;39(6):246-259. No abstract available.
Results Reference
result
PubMed Identifier
30859131
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. Epub 2019 Feb 28.
Results Reference
result

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

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