The effect of white and pink noise on dental anxiety in children during dental treatment
| ISRCTN | ISRCTN11867479 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11867479 |
| Secondary identifying numbers | 3551 |
- Submission date
- 08/07/2025
- Registration date
- 28/07/2025
- Last edited
- 28/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims :
1. To compare the effectiveness of white noise and pink noise in reducing dental anxiety
2. To determine whether white or pink noise is more beneficial in calming children during dental procedures
3. To assess the potential of using sound therapy as a non-pharmacological method for anxiety management in pediatric dentistry
Who can participate?
Children aged 6–9 years receiving dental care (pulpotomy) at the Faculty of Dentistry, Damascus University
What does the study involve?
Before treatment, anxiety levels were evaluated by asking the child to select the face that best represented their emotional state. Baseline pulse rate was also recorded. Headphones were placed on the child for 10 minutes before the start of treatment, connected to a mobile phone playing a randomly assigned audio track (white or pink noise). Pulse rate was recorded again after 10 minutes of exposure to the sound.
The pulpotomy was performed using the standard technique. Anxiety levels and pulse readings were recorded again after anesthesia, after rubber dam placement, during pulp chamber access, and at the end of treatment and restoration.
What are the possible benefits and risks of participating?
Participating in the study may help reduce dental anxiety in children by introducing calming auditory stimuli (white or pink noise) during treatment. This could lead to a more comfortable experience for the child and may contribute to improved cooperation and better treatment outcomes.
There are minimal risks involved; the use of white and pink noise is non-invasive and safe. However, some children may find certain sounds unfamiliar or mildly irritating, and they are free to withdraw from the study at any time if discomfort occurs.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
27/05/2024 and will run for six months
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Dana Araman, danaaraman15@gmail.com
Contact information
Public, Scientific, Principal Investigator
Mazzeh
Damascus
-
Syria
| Phone | +963 (0)997215631 |
|---|---|
| danaaraman15@gmail.com |
Study information
| Study design | Randomized controlled clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Efficacy |
| Scientific title | The effect of white and pink noise on dental anxiety among children aged 6-9 years during pulpotomy procedure: a randomized controlled clinical study |
| Study objectives | The study aims to determine which type of auditory stimulus is more effective in creating a calming effect during dental treatment therapy, improving the overall patient experience and cooperation |
| Ethics approval(s) | Ethics approval not required |
| Health condition(s) or problem(s) studied | Dental anxiety in children during pulpotomy |
| Intervention | Three groups: white noise, pink noise and control group Before treatment, anxiety levels were evaluated using the facial image scale (FIS) by asking the child to select the face that best represented their emotional state. Baseline pulse rate was also recorded. Headphones were placed on the child for 10 minutes prior to the start of treatment, connected to a mobile phone playing a randomly assigned audio track (white or pink noise). Pulse rate was recorded again after 10 minutes of exposure to the sound. The pulpotomy was performed using the standard technique in accordance with the American Academy of Pediatric Dentistry (AAPD) guidelines. Inferior alveolar nerve block anesthesia was administered. FIS and pulse readings were recorded again post-anesthesia, after rubber dam placement, during pulp chamber access, and at the end of treatment and restoration. |
| Intervention type | Other |
| Primary outcome measure | 1. Anxiety measured using facial image scale at T0 = before starting the work, T1 = immediately after anesthesia and T2 = after the procedure is completed 2. Anxiety measured using pulse rate at T0 = before starting work, T1 = after 10 minutes of listening to music, T2 = immediately after anesthesia, T3 = when installing the rubber dam, T4 = when opening the pulp cavity, T5 = after the procedure is completed |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 27/05/2024 |
| Completion date | 01/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 9 Years |
| Sex | Both |
| Target number of participants | 75 |
| Total final enrolment | 75 |
| Key inclusion criteria | 1. Children aged 6–9 years 2. With or without previous dental experience 3. Mandibular molars requiring pulpotomy |
| Key exclusion criteria | 1. Children with systemic, mental, or auditory disorders 2. Children who dislike listening to music |
| Date of first enrolment | 01/10/2024 |
| Date of final enrolment | 01/12/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Syria
Sponsor information
University/education
Mazzeh Street
Damascus
80789
Syria
| Phone | +963 (11)33923223 |
|---|---|
| ap.srd@damascusuniversity.edu.sy | |
| Website | damasuniv.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Data sharing statement to be made available at a later date |
| Publication and dissemination plan | |
| IPD sharing plan | The datasets generated during the current study will be available upon request at a later date |
Editorial Notes
28/07/2025: Study's existence confirmed by Damascus University.
