- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07687953
Effect of Music Listening on Anxiety During Diode Laser Frenectomy
Effect of Music Listening on Anxiety, Stress, and Pain During Frenectomy: A Randomized Controlled Trial
This randomized controlled trial evaluated the effect of music listening on anxiety, stress, and pain in patients undergoing diode laser frenectomy. Participants were adults aged 18 to 65 years who were scheduled to receive frenectomy as part of their routine periodontal treatment. Participants were allocated into two groups: a music group, in which patients listened to a pre-recorded music performance during the procedure, and a control group, in which patients received the routine procedure without music.
Anxiety and stress levels were assessed using validated questionnaires before and after the procedure. Postoperative pain was evaluated using a visual analogue scale. In the music group, patients also completed an additional questionnaire about their experience with music during the procedure. The study aimed to determine whether listening to music during frenectomy could improve patient comfort by reducing anxiety, perceived stress, and pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dental anxiety, perceived stress, and postoperative pain can negatively affect patient comfort and cooperation during minor oral surgical procedures. Music listening is a simple, low-cost, and non-pharmacological approach that may help reduce anxiety and improve the perioperative experience.
This randomized controlled trial was conducted in adult patients scheduled for diode laser frenectomy as part of routine periodontal care. Participants were allocated to either a music listening group or a control group. In the music group, patients listened to a pre-recorded instrumental music performance during the procedure. The music recording was performed by academic staff from the Department of Instrument Education, Turkish Music State Conservatory, Necmettin Erbakan University. Patients in the control group underwent the same routine diode laser frenectomy procedure without music listening.
The study evaluated patient-centered outcomes related to anxiety, perceived stress, and pain. Dental anxiety was assessed before and after the procedure using validated dental anxiety scales. Perceived stress was assessed before and after the procedure using the Perceived Stress Scale. Postoperative pain intensity was evaluated using a visual analogue scale. In addition, participants in the music group completed a questionnaire about their experience with music listening during the procedure, including their comfort, satisfaction, and willingness to receive music during a similar treatment in the future.
The purpose of the study was to determine whether music listening during diode laser frenectomy could reduce anxiety, stress, and pain and improve patient comfort during routine periodontal surgical care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Meram
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Konya, Meram, Turkey (Türkiye), 42090
- Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 to 65 years Patients scheduled for diode laser frenectomy as part of routine periodontal treatment Patients who completed phase 1 periodontal treatment before frenectomy Patients who agreed to participate in the study and signed the informed consent form Patients who smoked fewer than 10 cigarettes per day, if applicable
Exclusion Criteria:
- Patients with any uncontrolled systemic disease Pregnant or breastfeeding patients Patients younger than 18 years or older than 65 years Patients who smoked 10 or more cigarettes per day Patients who did not agree to participate or did not provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music Listening Group
Participants in this group listened to pre-recorded instrumental music during diode laser frenectomy in addition to routine clinical care.
|
Participants assigned to the music listening group listened to a pre-recorded instrumental Turkish music performance during diode laser frenectomy.
The music was played as an adjunct to routine clinical care and was intended to improve patient comfort during the procedure.
Participants in the control group received the same routine diode laser frenectomy procedure without music listening.
Other Names:
|
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No Intervention: Control Group
Participants in this group underwent routine diode laser frenectomy without music listening.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Modified Dental Anxiety Scale Score
Time Frame: Preoperative and immediately postoperative
|
Dental anxiety was assessed using the Modified Dental Anxiety Scale before and after diode laser frenectomy.
Higher scores indicate greater dental anxiety.
The change in score from preoperative to postoperative assessment was compared between the music listening group and the control group.
|
Preoperative and immediately postoperative
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- NEU-DHF-PERIO-FM
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.
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