NCT03923088

Brief Summary

Dental anxiety is fear associated with the thought of visiting the dentist for preventive care and dental procedures. Children with dental anxiety characterized by crying before dental checkup, tachycardia and aggressively clinging to the accompanying parent. It has been cited as the fifthmost common cause of anxiety by Agras et al. Dental anxiety may have major and long-lasting implications for the child and their family. Cohen et al reported that dental anxiety affects an individual's life in multiple ways. The physiological impacts included signs and symptoms of the fright response and feelings of exhaustion after a dental appointment, while the cognitive impacts included an array of negative thoughts, beliefs, and fears. Dental anxiety in children could remain a problem in adulthood if not handled properly thus it will affect oral health and psycho-social condition. This research is conducted to deliver different concepts in psychological and behavioral techniques in management of anxious pediatric dental patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

April 16, 2019

Last Update Submit

April 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • cooperation measured by modified venham rating scale

    Modified Venham rating scale provides details of positive and negative child's behavior. The scale ranges from total cooperation (0) to no cooperation (5)

    1 hour

Study Arms (3)

jacobson's progressive muscle relaxation technique

EXPERIMENTAL
Behavioral: jacobson's progressive muscle relaxation technique

audiovisual distraction technique

EXPERIMENTAL
Behavioral: audio-visual distraction technique

conventional

NO INTERVENTION

Interventions

This involves tensing specific muscle groups for 5-7 seconds, followed by 20 seconds of relaxation. The method can be demonstrated chairside, and should be practiced and rehearsed by the patient at home. Four major muscle groups are commonly tensed and relaxed. These are: 1) feet, calves, thighs, and buttocks; 2) hands, forearms, and biceps; 3) chest, stomach, and lower back; and 4) head, face, throat, and shoulders

jacobson's progressive muscle relaxation technique

audiovisual distraction not only leads to full involvement of scenes (visual and auditory), but it also induces a positive emotional reaction resulting in a relaxed experience.

audiovisual distraction technique

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children: 6 to 9 years old children. Teeth: tooth requiring dental treatment

You may not qualify if:

  • Children having allergy to local anaesthesia or systemic problem. Refusal of participation Mentally ill or mentally retarded children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator Dina Hussien Abdelhafez

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 22, 2019

Study Start

June 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

April 22, 2019

Record last verified: 2019-04