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Completed

NCT Number: NCT04731181

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

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

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry - Cairo University

Cairo, Egypt

About this study

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)

  • 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-pictorial scale.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mobile application (little lovely dentist).

Behavioral

mobile application

Primary outcomes

  1. Preoperative anxiety

    Time frame: before administration of local anesthesia during the first dental visit

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

  2. postoperative anxiety

    Time frame: immediately after administration of local anesthesia during the first dental visit

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

  3. Preoperative anxiety score

    Time frame: before administration of local anesthesia during the first dental visit

    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

  4. post-operative anxiety score

    Time frame: immediately after administration of local anesthesia during the first dental visit

    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

Secondary outcomes

  1. Postoperative pain

    Time frame: immediately after administration of local anesthesia during the first dental visit

    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

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

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

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 29, 2021
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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