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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03428282
Date of registration:	26/12/2017
Prospective Registration:	No
Primary sponsor:	Damascus University
Public title:	Pain and Anxiety Control During Traditional Mandibular Anesthesia in Children Using Distracting Tools
Scientific title:	Effectiveness of Audio Visual Distraction Using Virtual Reality Eyeglasses Versus Tablet Device in Child Behavioral Management During Inferior Alveolar Nerve Block
Date of first enrolment:	May 15, 2017
Target sample size:	102
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03428282
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
Phase:	N/A

Countries of recruitment
Syrian Arab Republic

Contacts

Name:	Nada Bshara, MD MSc Phd
Address:
Telephone:
Email:
Affiliation:	Associate Professor of Pedodontics, University of Damascus Dental School, Syria

Name:	Zuhair AlNerabieah, DDS
Address:
Telephone:
Email:
Affiliation:	MSc student in Pedodontics, University of Damascus Dental School, Syria

Name:	Mohammed Nour Al-Halabi, DDS
Address:
Telephone:
Email:
Affiliation:	MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria

Key inclusion & exclusion criteria

Inclusion Criteria:

1. age between 6 and 10 years.

2. no previous dental experience.

3. definitely positive or positive ratings of Frank scale.

4. Need of IAN block for any dental treatment.

Exclusion Criteria:

1. previous dental experience

2. systematic or mental disorders.

3. definitely negative or negative ratings of Frankel scale

4. Any contraindication for regional anesthesia

Age minimum: 6 Years
Age maximum: 10 Years
Gender: All

Health Condition(s) or Problem(s) studied

Inferior Alveolar Nerve Block

Intervention(s)

Procedure: Tablet Device

Drug: Anesthesia

Procedure: VR Box

Primary Outcome(s)

Pain levels [Time Frame: five minutes following the inferior alveolar nerve block injection.]

Change in physiological pulse rate [Time Frame: (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug]

Anxiety levels [Time Frame: Within the first minute of injecting the needle into the oral mucosa (oral tissues).]

Secondary Outcome(s)

Secondary ID(s)

UDDS-Pedo-03-2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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