The use of a dental storybook for reduction of dental anxiety among children
| ISRCTN | ISRCTN44193972 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44193972 |
| Secondary identifying numbers | IRB E-18-3190, CDRC (No. PR 0104). |
- Submission date
- 02/02/2022
- Registration date
- 04/02/2022
- Last edited
- 06/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Dental anxiety is fear, anxiety or stress associated with a dental setting. Dental anxiety is one of the major challenges in child dentistry that may result in the avoidance of dental treatment and affect the overall treatment quality.
Aim: To evaluate the effectiveness of a specially-designed dental storybook in reducing dental anxiety among children.
Who can participate?
Children aged 6-8 years old due to have dental treatment
What does the study involve?
Children were randomly divided into two groups: the intervention group (received the storybook) and the control group. Three dental visits (screening, examination and cleaning, and treatment) were provided for each child. Anxiety and behavior were assessed following each visit.
What are the possible benefits and risks of participating?
Benefits: children benefited from having the storybooks, fluoride application, and dental cavities treatment
Risks: there are no potential risks expected
Where is the study run from?
Dental University Hospital, King Saud University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
January 2019 to March 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr. Alrouh Alsaadoon, alrouhms@gmail.com
Contact information
Public
Almursalat
Riyadh
11612
Saudi Arabia
| Phone | +966 533399779 |
|---|---|
| 437203999@student.ksu.edu.sa |
Scientific
Almursalat
Riyadh
11612
Saudi Arabia
| Phone | +966 533399779 |
|---|---|
| alrouhms@gmail.com |
Study information
| Study design | Multicenter interventional double-blinded randomized 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 contact details to request a participant information sheet |
| Scientific title | The use of a dental storybook as a dental anxiety reduction medium among pediatric patients: A randomized controlled clinical trial |
| Study objectives | Children who receive the dental storybook will show a reduction of dental anxiety levels compared to those who will not receive it. |
| Ethics approval(s) | Approved 20/03/2019, Institutional Review Board (IRB) at the College of Medicine, King Saud University (P.O.Box, 7805 Riyadh 11472 DEM 65, Saudi Arabia; +966 114691531; irb.medksu@hotmail.com), ref: PR 0104 |
| Health condition(s) or problem(s) studied | Dental anxiety in children |
| Intervention | Eighty-eight children (6–8 years old) were randomly divided into two groups: the intervention group (received the storybook) and the control group (did not receive the storybook). Three dental visits (screening, examination and cleaning, and treatment) were provided for each child. Anxiety was assessed following each visit using the Children’s Fear Survey Schedule-Dental Subscale (CFSS-DS) and the Venham clinical anxiety scale (VCAS). The behavior was assessed using Frankl’s scale. All the eligible children were randomized to one of the two groups using the block randomization method: an intervention group (who received the storybook) and a control group (who did not receive the storybook). The required sample size of 105 was divided into seven blocks with 15 subjects in each block. A block of 15 two-digit random numbers was generated from which odd/even random numbers were allotted to the intervention and control groups. An independent trial investigator performed allocation concealment with sequentially numbered, opaque, and sealed envelopes (not measuring the study’s outcomes). The allocation ratio was intended to be equal. The main investigator (outcome assessor AR. S) was blinded to the group allocations. |
| Intervention type | Behavioural |
| Primary outcome measure | Dental anxiety is measured using the self-report 15-items Arabic Version of Children’s Fear Survey Schedule-Dental Subscale (CFSS-DS) questionnaires, and Venham clinical anxiety scale (VCAS) at screening visit, examination visit, and treatment visit (with a one-week interval between each visit). |
| Secondary outcome measures | Behavior was assessed using Frankl’s behavior rating scale at screening visit, examination visit, and treatment visit (with a one-week interval between each visit). |
| Overall study start date | 15/01/2019 |
| Completion date | 22/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 8 Years |
| Sex | Both |
| Target number of participants | 88 |
| Total final enrolment | 88 |
| Key inclusion criteria | 1. Children aged 6-8 years old 2. Medically fit children with ASA I (a normal healthy patient) according to the American Society of Anesthesiologists Classification 3. Children/parents who can read and understand Arabic 4. The need for restorative treatment (occlusal fillings) that required local anesthesia in the upper arch |
| Key exclusion criteria | 1. Children with special needs 2. Children who have a complete audio-visual impairment 3. Children with learning difficulties or mental retardation 4. Children of non-Arabic speakers 5. Previous treatment with nitrous, sedation, or general anesthesia 6. Conditions requiring emergency dental treatment (abscess, draining sinus, cellulitis) 7. The need for pharmacological management to cooperate; and known dental phobia |
| Date of first enrolment | 21/03/2019 |
| Date of final enrolment | 10/03/2020 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
P.O BOX 60169
Riyadh
12372
Saudi Arabia
Sponsor information
Government
P.O BOX 145111
Riyadh
11362
Saudi Arabia
| Phone | +966 114670000 |
|---|---|
| info@ksu.edu.sa | |
| Website | http://ksu.edu.sa/en/ |
"ROR" |
https://ror.org/02f81g417 |
Funders
Funder type
University/education
Government organisation / Local government
- Location
- Saudi Arabia
Results and Publications
| Intention to publish date | 09/02/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/03/2022 | 04/04/2022 | Yes | No | |
| Results article | 22/08/2022 | 06/03/2024 | Yes | No |
Editorial Notes
06/03/2024: Publication reference added.
04/04/2022: Publication reference added.
04/02/2022: Trial's existence confirmed by King Saud University.
