NCT07687953

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

June 30, 2026

Last Update Submit

June 30, 2026

Conditions

Keywords

Music ListeningFrenectomyPerceived Stress Scale

Outcome Measures

Primary Outcomes (1)

  • Change in Modified Dental Anxiety Scale Score

    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

Study Arms (2)

Music Listening Group

EXPERIMENTAL

Participants in this group listened to pre-recorded instrumental music during diode laser frenectomy in addition to routine clinical care.

Behavioral: Music Listening

Control Group

NO INTERVENTION

Participants in this group underwent routine diode laser frenectomy without music listening.

Interventions

Music ListeningBEHAVIORAL

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.

Also known as: Music Intervention, Music Listening During Frenectomy, Intraoperative Music Listening
Music Listening Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology

Konya, Meram, 42090, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

April 28, 2025

Primary Completion

October 1, 2025

Study Completion

October 31, 2025

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations