Musical Intervention for Dental Anxiety

NCT07240233 | Enrolling By Invitation

• 1 other identifier: NP110925
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if listening to music during dental procedures lowers anxiety in adults. The main questions it aims to answer are: does music during the procedure lower dental anxiety, and does wearing headphones without audio to reduce ambient noise also lower dental anxiety. Researchers will compare three groups to see these effects: music via headphones, headphones without audio, and standard care without headphones or music. Participants will:

• Complete a short anxiety questionnaire before the dental procedure.
• Receive one of the three approaches during the procedure: music via headphones, headphones without audio, or no headphones/music.
• Complete a short anxiety questionnaire after the dental procedure.

Conditions

Dental Anxiety

Keywords

Dental anxiety; Dental fear; Odontophobia; Music therapy; Therapeutic music listening

Outcome Measures

Primary Outcomes (2)

• State Anxiety

  State anxiety measured by the STAI Y-1 - State Anxiety Inventory

  Participants are assessed at the beginning and at the end of each dental appointment throughout a 5-month period

• Dental anxiety

  Dental anxiety measured by the MDAS - Modified Dental Anxiety Scale

  Participants are assessed at the beginning and at the end of each dental appointment throughout a 5-month period

Study Arms (3)

Music via headphones

EXPERIMENTAL

Participants wear wireless, supra-aural headphones delivering a standardized playlist of classical and baroque pieces

Other: Music via headphones

Headphones without audio

ACTIVE COMPARATOR

Participants wear the same model headphones with no audio to provide passive attenuation of ambient noise

Other: Headphones without audio

Standard care

NO INTERVENTION

no headphones or music; routine dental care proceeds per usual practice

Interventions

Music via headphones OTHER

Wear wireless, supra-aural headphones delivering a standardized playlist of classical and baroque pieces

Music via headphones

Headphones without audio OTHER

wear the same model headphones with no audio to provide passive attenuation of ambient noise

Headphones without audio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults receiving care at the university-affiliated dental clinic, legally able to consent and willing to participate voluntarily.
• Ability to read and independently complete brief self-report questionnaires before and after the visit.

You may not qualify if:

• Self-reported hearing impairment, current use of hearing aids, or other auditory conditions that interfere with safe headphone use or outcome validity.
• Use of sedative medication prior to the visit for the current appointment, or acute intoxication that may alter anxiety ratings.
• Cognitive impairment or other condition that limits capacity to provide informed consent or to complete study questionnaires reliably.
• Unwillingness to wear headphones during the procedure if randomized to a headphone arm, or refusal to participate/withdrawal of consent at any time.
• Any urgent clinical indication that, in the clinician's judgment, precludes headphone use (for example, need for uninterrupted verbal interaction or imaging incompatible with wearing the device).
• Reported history of severe adverse reactions to headphone use (for example, marked discomfort, vertigo) or skin sensitivity incompatible with device contact points.
• Inability to protect privacy or comply with basic study procedures (for example, cannot complete pre- and post-visit questionnaires within the clinic workflow)

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead

Study Sites (1)

Egas Moniz School of Health and Science

Almada, Portugal

Location

Related Publications (14)

• Zwiri A, Alam MK, Alshammari WA, Almazyad FM, Noor NFBM. Exploration of the Role of Music Therapy in Reducing Dental Anxiety. J Pharm Bioallied Sci. 2025 Jun;17(Suppl 2):S1273-S1275. doi: 10.4103/jpbs.jpbs_85_25. Epub 2025 Jun 18.

  PMID: 40655808 BACKGROUND

• T Zaatar M, Alhakim K, Enayeh M, Tamer R. The transformative power of music: Insights into neuroplasticity, health, and disease. Brain Behav Immun Health. 2023 Dec 12;35:100716. doi: 10.1016/j.bbih.2023.100716. eCollection 2024 Feb.

  PMID: 38178844 BACKGROUND

• Steenen SA, Linke F, van Westrhenen R, de Jongh A. Interventions to reduce adult state anxiety, dental trait anxiety, and dental phobia: A systematic review and meta-analyses of randomized controlled trials. J Anxiety Disord. 2024 Jul;105:102891. doi: 10.1016/j.janxdis.2024.102891. Epub 2024 Jun 24.

  PMID: 38945067 BACKGROUND

• Shih KC, Hsu WT, Yang JL, Man KM, Chen KB, Lin WY. The Effect of Music Distraction on Dental Anxiety During Invasive Dental Procedures in Children and Adults: A Meta-Analysis. J Clin Med. 2024 Oct 29;13(21):6491. doi: 10.3390/jcm13216491.

  PMID: 39518630 BACKGROUND

• Packyanathan JS, Lakshmanan R, Jayashri P. Effect of music therapy on anxiety levels on patient undergoing dental extractions. J Family Med Prim Care. 2019 Dec 10;8(12):3854-3860. doi: 10.4103/jfmpc.jfmpc_789_19. eCollection 2019 Dec.

  PMID: 31879625 BACKGROUND

• Lee HY, Nam ES, Chai GJ, Kim DM. Benefits of Music Intervention on Anxiety, Pain, and Physiologic Response in Adults Undergoing Surgery: A Systematic Review and Meta-analysis. Asian Nurs Res (Korean Soc Nurs Sci). 2023 Aug;17(3):138-149. doi: 10.1016/j.anr.2023.05.002. Epub 2023 Jun 3.

  PMID: 37276961 BACKGROUND

• Hao T, Pang J, Liu Q, Xin P. A systematic review and network meta-analysis of virtual reality, audiovisuals and music interventions for reducing dental anxiety related to tooth extraction. BMC Oral Health. 2023 Sep 22;23(1):684. doi: 10.1186/s12903-023-03407-y.

  PMID: 37735362 BACKGROUND

• de Witte M, Pinho ADS, Stams GJ, Moonen X, Bos AER, van Hooren S. Music therapy for stress reduction: a systematic review and meta-analysis. Health Psychol Rev. 2022 Mar;16(1):134-159. doi: 10.1080/17437199.2020.1846580. Epub 2020 Nov 27.

  PMID: 33176590 BACKGROUND

• Dalli OE, Yildirim Y, Aykar FS, Kahveci F. The effect of music on delirium, pain, sedation and anxiety in patients receiving mechanical ventilation in the intensive care unit. Intensive Crit Care Nurs. 2023 Apr;75:103348. doi: 10.1016/j.iccn.2022.103348. Epub 2022 Dec 2.

  PMID: 36470699 BACKGROUND

• Crego A, Carrillo-Diaz M, Armfield JM, Romero M. From public mental health to community oral health: the impact of dental anxiety and fear on dental status. Front Public Health. 2014 Feb 28;2:16. doi: 10.3389/fpubh.2014.00016. eCollection 2014.

  PMID: 24616889 BACKGROUND

• Aravena PC, Almonacid C, Mancilla MI. Effect of music at 432 Hz and 440 Hz on dental anxiety and salivary cortisol levels in patients undergoing tooth extraction: a randomized clinical trial. J Appl Oral Sci. 2020;28:e20190601. doi: 10.1590/1678-7757-2019-0601. Epub 2020 May 11.

  PMID: 32401941 BACKGROUND

• Ainscough SL, Windsor L, Tahmassebi JF. A review of the effect of music on dental anxiety in children. Eur Arch Paediatr Dent. 2019 Feb;20(1):23-26. doi: 10.1007/s40368-018-0380-6. Epub 2018 Oct 29.

  PMID: 30374854 BACKGROUND

• Aardal V, Willumsen T, Evensen KB. Differences in anxiety, depression, and oral health-related quality of life among dental anxiety patients with and without reported abuse experience. Eur J Oral Sci. 2024 Apr;132(2):e12976. doi: 10.1111/eos.12976. Epub 2024 Feb 2.

  PMID: 38305706 BACKGROUND

• Aardal V, Evensen KB, Willumsen T, Hervik Bull V. The complexity of dental anxiety and its association with oral health-related quality of life: An exploratory study. Eur J Oral Sci. 2023 Feb;131(1):e12907. doi: 10.1111/eos.12907. Epub 2022 Nov 23.

  PMID: 36418106 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: November 20, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

PT (1)