Clinical trial NCT04932759: The Effect Of Music Listened By Patients With Moderate Dental Anxiety During The Restoration Of Occlusal Caries
Official title: Investigation Of The Effect Of Music Listened By Patients With Moderate Dental Anxiety During The Restoration Of Posterior Occlusal Dental Caries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Music
Physical Stress
Keywords: dental anxiety
music
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control and study group
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is aimed to evaluate the effect of music listened by patients with moderate dental anxiety during the restoration of posterior occlusal dental caries on vital signs of the participants.

Detailed description: The study will be applied on 70 patients; 35 patients will be in the control group (the group not listening to music during treatment), 35 patients will be in the experimental group (the group listening to music during treatment).

Modified Dental Anxiety Scale consisting of 5 questions will be applied to the participants who come to the clinic and have occlusal dental caries in the posterior region. The participants whose scores are between 10-18 according to this scale will be included in the study. One occlusal tooth decay will be treated. Before starting treatment, saliva cortisol levels, heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements will be made. The participants will be asked to spit in sterile plastic containers for saliva cortisol measurement. During dental treatment, the participants will listen to music in experimental group. In control group the participant will not listen to music. Heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements will be repeated in the middle of the treatment (without going through the restoration phase when the cavity is opened). Saliva cortisol levels, heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements will be repeated when the treatment is completed. The questionnaire containing the modified dental anxiety scale will be re-administered to the participants.

Eligibility criteria: Inclusion Criteria:

Must be healthy volunteers, Clinical diagnosis of at least one occlusal dental caries, Must have moderate dental anxiety

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Exclusion Criteria:Unhealthy volunteers, Teeth with dental cavities in the adjacent teeth where the rubber dam would not be placed, and dental caries closer than 1 mm to the pulp tissue were not included in the study

Primary outcomes:
measure: Salivary cortisol level
timeFrame: Before-after
measure: Vital anxiety signs
timeFrame: Before-after
Secondary outcomes:
measure: Modified dental anxiety questionnaire
timeFrame: Before-after
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Faculty of Dentistry
Study officials:
affiliation: Asst Prof
name: KIVANÇ DÜLGER
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Mejia-Rubalcava C, Alanis-Tavira J, Mendieta-Zeron H, Sanchez-Perez L. Changes induced by music therapy to physiologic parameters in patients with dental anxiety. Complement Ther Clin Pract. 2015 Nov;21(4):282-6. doi: 10.1016/j.ctcp.2015.10.005. Epub 2015 Oct 27.
citation: Bradt J, Teague A. Music interventions for dental anxiety. Oral Dis. 2018 Apr;24(3):300-306. doi: 10.1111/odi.12615. Epub 2017 Jan 5.