The effect of vibration on anxiety and pain during a dental shot in children
| ISRCTN | ISRCTN43760800 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43760800 |
| Secondary identifying numbers | MS994 |
- 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
Plain English Summary
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
Scientific
Tanzeem Kafafrsouseh - Building N.243
Damascus
22743
Syria
 ORCID ID |
0000-0002-0793-8689 |
|---|---|
| Phone | +963 (0)932075397 |
| amer93albouni@gmail.com |
Study information
| Study design | Randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effect of vibration on anxiety and pain during injections of local anesthesia in children |
| Study hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Vibraject |
| Primary outcome measure | 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 |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 20/04/2020 |
| Overall study end date | 01/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 30 |
| Participant inclusion criteria | 1. Medically fit children 2. Required bilateral maxillary dental treatment 3. Positive or definitely positive behavior |
| Participant exclusion criteria | 1. Children suffering from medical illness 2. Cannot comprehend the pain measures 3. Negative or definitely negative behavior |
| Recruitment start date | 28/04/2021 |
| Recruitment end date | 01/08/2021 |
Locations
Countries of recruitment
- Syria
Study participating centre
Mazzah High Way
Damascus
22743
Syria
Sponsor information
University/education
Alabaramkeh
Damascus
22743
Syria
| Phone | +963 (0)1133923192 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | After finishing the procedure and writing the article, the researchers are planning to publish (with all results, statistical analysis and some photos) in Damascus University's journal, and many other international journals. |
| 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). |
Editorial Notes
10/05/2021: Trial's existence confirmed by Damascus University.
