The Effect of Music and White Noise on Patients' Anxiety and Pain During Surgery for Impacted Mandibular Third Molar

NCT06814366 | Completed DMC

• 1 other identifier: AU-FD-OMFS-MAK-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effect of music and whitenoise on the anxiety and pain level of patients who had impacted third molars surgery. The main questions it aims to answer are:

• Does music and white noise have an effect on the patient's intraoperative pain/pressure/discomfort?
• Does music and white noise have an effect on the patient's anxiety level? The researchers compared the music and white noise, music-only and ambient noise groups to see if there was an effect on anxiety and pain levels. STAI-S form was applied to all participants before surgery. They marked their anxiety levels on the VAS scale. After the procedure, STAI-S form was applied and they marked the anxiety levels on the VAS scale. The pressure/pain level which they felt during the procedure was evaluated by VAS scale.

Conditions

Anxiety State; Pain

Keywords

tooth extraction; anxiety; white noise

Outcome Measures

Primary Outcomes (3)

• STAI-S

  State anxiety measured on STAI-S (Spielberger State Anxiety Inventory). The total score can range from 20 to 80, with higher scores indicating more anxiety.

  preoperative and through the surgery is over, about an hour after the patient entered the operating room

• ANXIETY VAS

  Anxiety measured on a VAS (Visual Analog Scale). A closed-ended scale of 0-10 cm ("0" no anxiety, "10" maximum imaginable anxiety) was used in the study

  preoperative and through the surgery is over, about an hour after the patient entered the operating room

• PAIN VAS

  Pain measured on a VAS (Visual Analog Scale ). A closed-ended scale of 0-10 cm ("0" no anxiety, "10" maximum imaginable anxiety) was used in the study

  perioperative

Other Outcomes (1)

• willingness

  through the surgery is over, about an hour after the patient entered the operating room

Study Arms (3)

group music and white noise

EXPERIMENTAL

Group music and white noise listened to a preselected playlist played against a pre-prepared standard white noise through headphones that prevent ambient noise during the procedure. The playlist consisted of popular songs of the time. The patient could choose the music they wanted to listen to from the playlist using a hand-held tablet.

Other: music and white noise intervention

group music only

EXPERIMENTAL

Group music listened to the same preselected playlist without white noise through noise-isolating headphones during the procedure. The patient could choose the music they wanted to listen to from the playlist using a hand-held tablet.

Other: music intervention

group control

NO INTERVENTION

Group control listened to the natural ambient noise during the procedure.

Interventions

music and white noise intervention OTHER

The experimental groups were played a combination of music and white noise through headphones that blocked ambient noise during the surgical procedure. A playlist consisting of the popular songs of the era was prepared in advance. The patient could choose the music they wanted to listen to from the playlist using a hand-held tablet.

group music and white noise

music intervention OTHER

The experimental groups were played music a through headphones that blocked ambient noise during the surgical procedure. A playlist consisting of the popular songs of the era was prepared in advance. The patient could choose the music they wanted to listen to from the playlist using a hand-held tablet.

group music only

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who applied to our clinic for impacted wisdom teeth extraction from the start date of the study
• Patients without any diagnosed psychological disorder
• Patients who gave their own voluntary consent to the study
• Patients who had no medical history that could affect third molar surgery,

You may not qualify if:

• Patients who do not agree to volunteer.
• Patients with any diagnosed psychological disorder
• Patients with mental and physical disorders that may hinder cooperation
• Pregnancy or lactating,
• Antidepressant or anxiolytic drug use, having a disease that could prevent the surgery,
• A severe infection around the impacted third molar
• A prior tooth extraction

Sponsors & Collaborators

• Alanya Alaaddin Keykubat University: lead
• Ankara University: collaborator

Study Sites (1)

Ankara University

Ankara, Yenimahalle/ankara, 06560, Turkey (Türkiye)

Location

Related Publications (3)

• Kim YK, Kim SM, Myoung H. Musical intervention reduces patients' anxiety in surgical extraction of an impacted mandibular third molar. J Oral Maxillofac Surg. 2011 Apr;69(4):1036-45. doi: 10.1016/j.joms.2010.02.045. Epub 2010 Aug 12.

  PMID: 20708320 BACKGROUND

• Song M, Li N, Zhang X, Shang Y, Yan L, Chu J, Sun R, Xu Y. Music for reducing the anxiety and pain of patients undergoing a biopsy: A meta-analysis. J Adv Nurs. 2018 May;74(5):1016-1029. doi: 10.1111/jan.13509. Epub 2017 Dec 21.

  PMID: 29171070 BACKGROUND

• Ilkkaya NK, Ustun FE, Sener EB, Kaya C, Ustun YB, Koksal E, Kocamanoglu IS, Ozkan F. The effects of music, white noise, and ambient noise on sedation and anxiety in patients under spinal anesthesia during surgery. J Perianesth Nurs. 2014 Oct;29(5):418-26. doi: 10.1016/j.jopan.2014.05.008.

  PMID: 25261145 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• mine alkaya karagoz, DDS

  Alanya Alaaddin Keykubat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal Investigator

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 7, 2025
• Study Start: May 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)