The effect of vibration on anxiety and pain during a dental shot in children

ISRCTN	ISRCTN43760800
DOI	https://doi.org/10.1186/ISRCTN43760800
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	MS994
Sponsor	Damascus University
Funder	Damascus University

Submission date: 12/04/2021
Registration date: 10/05/2021
Last edited: 10/05/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The most common reasons why people stop going to the dentist are dental insecurity and anxiety. Children who experience extreme discomfort during dental operations are more likely to have behavioral issues during later appointments, requiring more restraint and taking longer. Furthermore, children who are in pain will delay receiving appropriate dental treatment and are more likely to do so in the future. This study aims to evaluate the effect of a vibration-assisted syringe on pain and anxiety in children.

Who can participate?
Healthy children aged 6-10 years

What does the study involve?
Each child undergoes both anesthetic injections (the conventional injection and the vibration-assisted injection) at two separate dental visits 2 weeks apart. Pain and anxiety levels are compared at the two visits.

What are the possible benefits and risks of participating?
The vibration-assisted syringe may cause less pain. There are no known risks.

Where is the study run from?
Damascus University (Syria)

When is the study starting and how long is it expected to run for?
April 2020 to September 2021

Who is funding the study?
Damascus University (Syria)

Who is the main contact?
Dr Muhammad Amer Albouni
amer93albouni@gmail.com

Contact information

Dr Muhammad Amer Albouni
Scientific

Tanzeem Kafafrsouseh - Building N.243
Damascus
22743
Syria

ORCID ID	0000-0002-0793-8689
Phone	+963 (0)932075397
Email	amer93albouni@gmail.com

Study information

Primary study design	Interventional
Study design	Randomized controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The effect of vibration on anxiety and pain during injections of local anesthesia in children
Study objectives	To evaluate the effect of a vibration-assisted syringe on pain perception in children.
Ethics approval(s)	Approved 29/04/2020, Damascus University Rector (Baramkeh, Damascus, Syria; +966 (0)55 506 3806; no email), ref: 994MS
Health condition(s) or problem(s) studied	Pain perception during injections of local anesthesia
Intervention	This study is conducted using a split-mouth design. Each child is subjected to both anesthetic injections, the conventional injection and the vibration-assisted injection, at two separate dental visits. To determine if the vibratory device (Vibraject; Vibraject® MiltexInc LLC., York, PA, USA) is used or not for the first visit the operator selects one of two cards with either the letter V or C printed on (denoting vibration-assisted or conventional) from an opaque bag. To determine the first side (right or left) to be injected the researchers considered the child's chief complaint. There is no follow up.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Vibraject
Primary outcome measure(s)	1. Pain measured using the visual analogue score (VAS) at the end of anaesthesia 2. Anxiety measured using the faces anxiety scale (FAS) at the anaesthesia administration time
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	01/09/2021

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	30
Key inclusion criteria	1. Medically fit children 2. Required bilateral maxillary dental treatment 3. Positive or definitely positive behavior
Key exclusion criteria	1. Children suffering from medical illness 2. Cannot comprehend the pain measures 3. Negative or definitely negative behavior
Date of first enrolment	28/04/2021
Date of final enrolment	01/08/2021

Locations

Countries of recruitment

Syria

Study participating centre

Damascus University

Department of Pediatric Dentistry
Mazzah High Way
Damascus
22743
Syria

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Muhammad Amer Albouni (amer93albouni@gmail.com).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/05/2021: Trial's existence confirmed by Damascus University.