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Completed

NCT Number: NCT06814366

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University

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

About this study

Our study was carried out on 66 patients, who applied to Ankara University Department of Oral and Maxillofacial Surgery, suffering from impacted mandibular third molars.

Group white noise and music 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.

Group music only 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.

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

Surgical Procedure:

All patients were given a mouthwash with chlorhexidine gluconate before the surgery. Before the procedure, Nervus Alveolaris inferior block anesthesia and buccal infiltrative anesthesia were performed with 2.5% articain hydrochloride (Ultracain D-S forte ampoule, Sanofi Aventis) containing 1/100,000 epinephrine as a local anesthetic solution. In all three groups, a mucoperiosteal triangular flap was raised to reach the bone. After removing a sufficient amount of bone, the tooth was removed from the socket using a bein elevator. The original position of the flap was preserved, and the wounds were closed primarily using an atraumatic silk suture.

Data Collection The State-Trait Anxiety Inventory-State (STAI-S FORM) was administered to the patients before and after the procedure. Marking was made on the form containing a visual analog scale (VAS) for anxiety levels before the procedure. Post-procedure anxiety levels and pain/pressure feelings were marked on a separate form containing a VAS scale, and the desire to have the procedure performed again (1=never, 2=maybe/not sure, 3=willing) was questioned.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. STAI-S

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

    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.

  2. ANXIETY VAS

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

    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

  3. PAIN VAS

    Time frame: perioperative

    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

Other outcomes

  1. willingness

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

    The desire to undergo the surgical procedure again (1=never, 2=maybe/not sure, 3=willing) under the same conditions was questioned.

Sponsors and collaborators

Lead sponsor

Alanya Alaaddin Keykubat University

Other

Collaborators

  • Ankara University

Registry information

Official study title

The Effect of Music and White Noise on Patients' Anxiety and Pain During Surgery for Impacted Mandibular Third Molar: A Single-Blind Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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