- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06814366
The Effect of Music and White Noise on Patients' Anxiety and Pain During Surgery for Impacted Mandibular Third Molar
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yenimahalle/ankara
-
Ankara, Yenimahalle/ankara, Turkey, 06560
- Ankara University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group music and white noise
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.
|
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.
|
|
Experimental: group music only
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.
|
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.
|
|
No Intervention: group control
Group control listened to the natural ambient noise during the procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
preoperative and through the surgery is over, about an hour after the patient entered the operating room
|
|
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
|
preoperative and through the surgery is over, about an hour after the patient entered the operating room
|
|
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
|
perioperative
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
through the surgery is over, about an hour after the patient entered the operating room
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: mine alkaya karagoz, DDS, Alanya Alaaddin Keykubat University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU-FD-OMFS-MAK-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Cairo UniversityCompletedCervical Pain | Lumbar Pain SyndromeEgypt
Clinical Trials on music and white noise intervention
-
Brigham and Women's HospitalCompletedHealthy | Anxiety Disorders | Anxiety | Pain, Acute | Pain, Chronic | CatastrophizationUnited States
-
Celal Bayar UniversityNot yet recruitingNewborn | Breastfeeding | Music | MotherTurkey
-
University of MinnesotaTerminatedOvarian Cancer | Uterine CancerUnited States
-
National Taiwan University HospitalCompleted
-
Istanbul University - Cerrahpasa (IUC)Enrolling by invitationEndoscopy, Gastrointestinal | School Age ChildrenTurkey
-
Tel Aviv UniversityNot yet recruitingMajor Depressive Disorder (MDD)Israel
-
Istanbul University - Cerrahpasa (IUC)Completed
-
Toronto Metropolitan UniversityMitacs; Sonova Canada Inc.; Lucid, Inc.Completed
-
Saglik Bilimleri Universitesi Gazi Yasargil Training...CompletedPediatric SedationTurkey (Türkiye)
-
University of LiegeCompleted