Effectiveness of pink noise on reducing pain and anxiety during primary molars pulpotomy
| ISRCTN | ISRCTN17507312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17507312 |
- Submission date
- 02/08/2025
- Registration date
- 04/08/2025
- Last edited
- 04/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Pink noise has more energy in lower frequencies, making it sound deeper and more balanced, similar to natural sounds. Examples include the sound of crashing waves, falling rain, and rustling leaves. Pink noise improves sleep quality, aids relaxation, treats tinnitus, reduces stress, enhances comfort in office environments, boosts productivity, and decreases anxiety during dental procedures.
Another type of auditory stimulus used in clinical settings is children's songs, which serve as preferred music. These songs modulate pain-related activity in the brain's anterior cingulate cortex, and effectively raise pain thresholds by increasing endorphin production. Listening to music for 10 minutes is a sufficient duration to allow its anxiety-reducing effects to take hold. Studies suggest that waiting in dental clinics while listening to music is equally effective in lowering anxiety levels compared to taking benzodiazepines. The current study aimed to evaluate and compare the effects of pink noise and children's songs on anxiety and pain in children aged 6–9 years during pulpotomy procedures. The null hypothesis is that there is no significant difference in the reduction of anxiety and pain levels during pulpotomy procedures in children aged 6–9 years when exposed to pink noise compared to children’s songs.
Who can participate?
1. Children aged 6–9 years.
2. Classified as "definitely positive" or "positive" on Frankel’s behavior rating scale.
3. Requiring pulpotomy treatment in mandibular primary molars.
What does the study involve?
Following screening against inclusion criteria, 75 eligible patients were enrolled and randomly allocated into three study groups:
• Group 1: Pink noise (n = 25).
• Group 2: Children’s songs (n = 25).
• Group 3: Control group, tell-show-do (TSD) technique (n = 25).
What are the possible benefits and risks of participating?
Possible benefits are: Performing non-urgent dental treatment in the mandibular arch.
Possible risk is: Injection will be painful if the device is not effective.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
October 2024 and December 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Mawia Karkoutly, mawia95.karkoutly@damascusuniversity.edu.sy, mawiamaherkarkoutly@hotmail.com
Contact information
Public, Scientific, Principal Investigator
Mazzeh
Damascus
-
Syria
 ORCID ID |
0000-0003-0227-1560 |
|---|---|
| Phone | +963 992647528 |
| Mawia95.karkoutly@damascusuniversity.edu.sy |
Study information
| Study design | Randomized controlled trial with a double-blinded three-arm parallel-group |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effectiveness of pink noise on reducing pain and anxiety during primary molars pulpotomy compared with music: a randomized clinical trial |
| Study objectives | The current study aimed to evaluate and compare the effects of pink noise and children's songs on anxiety and pain in children aged 6–9 years during pulpotomy procedures. |
| Ethics approval(s) |
Approved 27/05/2024, The Biomedical Research Ethics Committee (BMREC) of Damascus University (Mazzeh, Damascus, -, Syria; +963 992647528; info@damascusuniversity.edu.sy), ref: N3551/2024 |
| Health condition(s) or problem(s) studied | Dental pain and anxiety |
| Intervention | Baseline anxiety levels were evaluated by measuring pulse rate and administering the FI scale. Children were shown two sets of five facial expressions and instructed to choose the image that best represented their current anxiety state. Children in the pink noise group listened using headphones. In the children's songs group, the child was asked to choose one of the songs from their favorite program and cartoon movies on YouTube, so that it would be familiar to them to listen to. The music or pink sound continued throughout the session through headphones. In the TSD technique group, the procedure was first explained verbally and then demonstrated in a child-friendly manner before treatment initiation. The "Do" phase was implemented during actual treatment without altering the initial explanation. Pulse rate was recorded after conditioning the child using the TSD technique or after listening to the songs or pink noise for 10 minutes. The conventional pulpotomy procedure is based on AAPD guidelines. Following IANB administration, pulse rate, FLACC behavioral pain scores, and FI scale ratings were documented. Pulse rate and FLACC behavioral pain scores were repeated after rubber dam placement and again following cavity preparation and pulp amputation, including during hemorrhage control with a moist cotton pellet. Final pulse rate and FI scale assessments were conducted upon completion. |
| Intervention type | Other |
| Primary outcome measure | 1. Pulse rate was objectively measured as an indicator of dental anxiety using a finger pulse oximeter (Alpha, Prolinx GmbH, Düsseldorf, Germany). Measurements were recorded at six critical time points: Baseline (t0). Following patient conditioning before treatment initiation (t1). Immediately after IANB administration (t2). Post rubber dam placement (t3). Following pulp amputation (t4). Upon treatment completion (t5) 2. The Face, Legs, Activity, Cry, and Consolability (FLACC) Behavioral Pain Assessment Scale (FLACC) behavioral pain scale, a nonverbal pain assessment tool, was recorded at three critical time points: Immediately after IANB administration (t2). Post rubber dam placement (t3). Following pulp amputation (t4) |
| Secondary outcome measures | Subjective anxiety levels were assessed using a 5-point pictorial scale (Facial Image (FI) Scale) with facial expressions ranging from very happy (score = 1) to very fearful (score = 5). The children were asked to choose the face that best matched their emotional state at three-time points: Baseline (t0), immediately after IANB administration (t2), and following pulp amputation (t4) |
| Overall study start date | 03/04/2024 |
| Completion date | 17/12/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| 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. Classified as "definitely positive" or "positive" on Frankel’s behavior rating scale. 3. Requiring pulpotomy treatment in mandibular primary molars. |
| Key exclusion criteria | 1. Children with oral, mental, and/or systemic conditions that could affect treatment outcomes. 2. Children who had taken sedative or analgesic medications within the 24 hours preceding the dental examination. |
| Date of first enrolment | 03/10/2024 |
| Date of final enrolment | 28/11/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
-
Syria
Sponsor information
University/education
Mazzeh
Damascus
-
Syria
| Phone | +963 992647528 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from mawia95.karkoutly@damascusuniversity.edu.sy, mawiamaherkarkoutly@hotmail.com The type of data that will be shared: Not currently known Timing for availability: Upon a reasonable request Whether consent from participants was required and obtained: Informed consent was obtained |
Editorial Notes
04/08/2025: Trial's existence confirmed by Damascus University.
