- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Meram
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Konya, Meram, Turecko (Türkiye), 42090
- Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Music Listening Group
Participants in this group listened to pre-recorded instrumental music during diode laser frenectomy in addition to routine clinical care.
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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.
Ostatní jména:
|
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Žádný zásah: Control Group
Participants in this group underwent routine diode laser frenectomy without music listening.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Modified Dental Anxiety Scale Score
Časové okno: Preoperative and immediately postoperative
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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.
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Preoperative and immediately postoperative
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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Informace o lécích a zařízeních, studijní dokumenty
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