Anxiety StateNCT06814366
The Effect of Music and White Noise on Patients' Anxiety and Pain During Surgery for Impacted Mandibular Third Molar
A study testing music and white noise intervention and music intervention in people with Anxiety State and Pain, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety State, Pain
- What is being tested?
- music and white noise intervention and music intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University
Ankara, Yenimahalle/ankara, 06560
About this study
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
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?
Read more
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.
Read the 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.
- Conditions
- Anxiety State, Pain
- Being tested
- music and white noise intervention, music intervention
- Keywords
- tooth extraction, anxiety, white noise
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music and white noise interventionOther
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 interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: music intervention |
| group control | No intervention | Group control listened to the natural ambient noise during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 May 2018
- Primary completion1 Aug 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Responsible party
- Principal investigator, Mine ALKAYA KARAGOZ, Ankara University
- Investigators
- mine alkaya karagoz, DDS, Principal investigator, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814366
- Sponsor's protocol ID
- AU-FD-OMFS-MAK-001
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20708320Song 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.
PubMed 29171070Ilkkaya 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.
PubMed 25261145
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06814366
- Acronym / sponsor ID
- AU-FD-OMFS-MAK-001
- Conditions
- Anxiety State, Pain
- Keywords
- tooth extraction, anxiety, white noise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group music and white noise | Experimental | Other: music and white noise interventionGroup 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. |
| group music only | Experimental | Other: music interventionGroup 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. |
| group control | No intervention | –Group control listened to the natural ambient noise during the procedure. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music and white noise interventionThe 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. | Other | group music and white noise |
| music interventionThe 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. | Other | group music only |
Primary outcome
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Background: PubMed 20708320Kim 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.
- Background: PubMed 29171070Song 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.
- Background: PubMed 25261145Ilkkaya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mine alkaya karagoz, DDS principal investigator
Alanya Alaaddin Keykubat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music and white noise intervention and music intervention in people with Anxiety State and Pain, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STAI-S (time frame: preoperative and through the surgery is over, about an hour after the patient entered the operating room). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06814366, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.