Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
Study NCT ID:
NCT06814366
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2025-01-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Music and White Noise on Patients' Anxiety and Pain During Surgery for Impacted Mandibular Third Molar
Sponsor:
Alanya Alaaddin Keykubat University
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: