Effectiveness of pink noise on reducing pain and anxiety during primary molars pulpotomy

Effectiveness of pink noise on reducing pain and anxiety during primary molars pulpotomy compared with music: a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17507312

Enrollment

Registered

2025-08-04

Start date

2024-10-03

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental pain and anxiety Oral Health

Interventions

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 repr

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
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)	—

Countries

Syria

Contacts

Public ContactMawia Karkoutly

Mawia95.karkoutly@damascusuniversity.edu.sy+963 992647528

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026