Individualized Music Versus Propofol for Perioperative Anxiety During Regional Anaesthesia
Comparing Professionally-prescribed Music by Music Therapist Versus Standard Practice Using Intravenous Sedative-hypnotic Agents on the Anxiolytic and Sedative Effect During Regional Anaesthesia: A Randomized Controlled Trial
Perioperative anxiety is common among patients undergoing surgery under regional anaesthesia. Intravenous sedative-hypnotic agents such as propofol are commonly administered to reduce anxiety and improve patient comfort; however, pharmacological sedation may reduce patient alertness and cause cardiorespiratory adverse effects. Music may provide a non-pharmacological alternative for reducing perioperative anxiety.
This prospective controlled study compared professionally prescribed individualized music with intravenous propofol sedation in adult patients undergoing surgery under regional anaesthesia. Participants in the music group received an individualized playlist curated by a professional music therapist following assessment of their music preferences and listening history. Participants in the sedative-hypnotic group received intravenous propofol sedation titrated according to clinical assessment.
Perioperative anxiety was assessed before and after surgery using the State-Trait Anxiety Inventory-State (STAI-S) and a visual analogue scale (VAS). Intraoperative sedation and alertness were assessed using the Bispectral Index (BIS) and Modified Observer's Assessment of Alertness/Sedation (mOAA/S), together with haemodynamic monitoring and patient satisfaction.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
This was a prospective, single-centre, parallel-group controlled study conducted at University Malaya Medical Centre, Kuala Lumpur, Malaysia. Adult patients scheduled for surgery under regional anaesthesia were allocated to either a music-therapy group or a sedative-hypnotic group according to their scheduled operating day.
Participants assigned to the music intervention underwent a preoperative assessment by a professional music therapist. The assessment included the participant's music-listening history and preferences, following which an individualized playlist was curated for intraoperative listening through headphones.
Participants assigned to the sedative-hypnotic group received intravenous propofol using target-controlled infusion, titrated according to clinical assessment and sedation monitoring.
Anxiety was evaluated preoperatively and postoperatively using STAI-S and an anxiety VAS. Intraoperative BIS, mOAA/S, haemodynamic variables and relevant rescue interventions were recorded. Postoperative patient satisfaction was also assessed.
The study received approval from the Medical Research Ethics Committee, University Malaya Medical Centre (MREC ID 2023418-12366), before participant recruitment, and written informed consent was obtained from all participants. The study was completed before registration on ClinicalTrials.gov.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Federal Territory of Kuala L
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Kuala Lumpur, Federal Territory of Kuala L, Malezja, 59100
- University Malaya Medical Centre
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Age 18 to 70 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- No sedative or anxiolytic medication received before surgery that could affect measurement of vital signs or Bispectral Index (BIS).
- Able to understand and communicate in Malay or English, understand the purpose and objectives of the study, and provide written informed consent.
- Surgery planned under regional anaesthesia (spinal, epidural, or peripheral nerve block).
- Surgery performed in the supine position.
Exclusion Criteria:
- Received general anaesthesia.
- Refused to participate.
- Hearing impairment.
- Diagnosed neurocognitive or psychiatric disorder.
- Aggressive or uncooperative behaviour.
- Surgery duration exceeding 3 hours.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Professionally Prescribed Individualized Music
Participants received professionally prescribed individualized music during surgery under regional anaesthesia.
Before surgery, a professional music therapist assessed each participant's music-listening history and preferences and curated an individualized playlist.
Music was delivered intraoperatively through headphones.
Rescue intravenous sedation could be administered when clinically required.
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Participants underwent a preoperative music assessment by a professional music therapist that included music-listening history and individual preferences.
Based on this assessment, the music therapist curated an individualized playlist for each participant.
The prescribed music was delivered intraoperatively through headphones during surgery under regional anaesthesia.
Participants remained awake without routine intravenous sedation, although rescue sedation could be administered when clinically required.
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Aktywny komparator: Intravenous Propofol Sedation
Participants received intravenous propofol sedation during surgery under regional anaesthesia using target-controlled infusion.
Propofol was titrated according to clinical assessment and sedation monitoring.
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Participants received intravenous propofol sedation by target-controlled infusion during surgery under regional anaesthesia.
Sedation was titrated according to clinical assessment using Bispectral Index (BIS) and Modified Observer's Assessment of Alertness/Sedation (mOAA/S) monitoring.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S)
Ramy czasowe: Perioperative period: During preoperative assessment at the operating theatre reception bay; And during postoperative assessment in the post-anaesthesia recovery room, on the day of surgery
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State anxiety was assessed using the 20-item State-Trait Anxiety Inventory-State (STAI-S) before and after surgery.
The total score ranges from 20 to 80, with higher scores indicating greater state anxiety.
The outcome was the change in STAI-S score from the preoperative to the postoperative assessment.
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Perioperative period: During preoperative assessment at the operating theatre reception bay; And during postoperative assessment in the post-anaesthesia recovery room, on the day of surgery
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Anxiety Visual Analogue Scale (VAS) Score
Ramy czasowe: Perioperative period: During preoperative assessment at the operating theatre reception bay; And during postoperative assessment in the post-anaesthesia recovery room, on the day of surgery
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Anxiety was assessed using a Visual Analogue Scale (VAS) ranging from 1 (least anxious) to 10 (most anxious), with higher scores indicating greater anxiety.
The outcome was the change in VAS score from the preoperative to the postoperative assessment.
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Perioperative period: During preoperative assessment at the operating theatre reception bay; And during postoperative assessment in the post-anaesthesia recovery room, on the day of surgery
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Intraoperative Bispectral Index (BIS)
Ramy czasowe: Every 10 minutes from the start of surgery until completion of surgery.
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Depth of sedation was assessed using the Bispectral Index (BIS).
BIS values were recorded at 10-minute intervals during surgery to assess the level of sedation during the assigned intervention.
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Every 10 minutes from the start of surgery until completion of surgery.
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Intraoperative Level of Sedation Measured by Modified Observer's Assessment of Alertness/Sedation (mOAA/S)
Ramy czasowe: Every 10 minutes from the start of surgery until completion of surgery.
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Alertness and sedation were assessed using the modified Observer's Assessment of Alertness/Sedation (mOAA/S) scale, ranging from 0 to 5. A score of 5 indicates that the participant is alert and responds readily to their name spoken in a normal tone, whereas a score of 0 indicates no response to a painful trapezius squeeze.
Higher scores therefore indicate greater alertness and lower levels of sedation.
mOAA/S was assessed at 10-minute intervals during surgery.
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Every 10 minutes from the start of surgery until completion of surgery.
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Intraoperative Systolic Blood Pressure
Ramy czasowe: Every 10 minutes from the start of surgery until completion of surgery.
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Systolic blood pressure was recorded at 10-minute intervals during surgery to assess haemodynamic changes during the assigned intervention.
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Every 10 minutes from the start of surgery until completion of surgery.
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Intraoperative Diastolic Blood Pressure
Ramy czasowe: Every 10 minutes from the start of surgery until completion of surgery
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Diastolic blood pressure was recorded at 10-minute intervals during surgery to assess haemodynamic changes during the assigned intervention.
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Every 10 minutes from the start of surgery until completion of surgery
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Intraoperative Heart Rate
Ramy czasowe: Every 10 minutes from the start of surgery until completion of surgery
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Heart rate was recorded at 10-minute intervals during surgery to assess haemodynamic changes during the assigned intervention.
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Every 10 minutes from the start of surgery until completion of surgery
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Postoperative Patient Satisfaction
Ramy czasowe: Postoperative period: During assessment in the post-anaesthesia recovery room, on the same day of surgery
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Overall satisfaction with the intervention provided during surgery was assessed using a verbal numerical rating scale ranging from 1 (least satisfied) to 10 (most satisfied), with higher scores indicating greater satisfaction.
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Postoperative period: During assessment in the post-anaesthesia recovery room, on the same day of surgery
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: MOHD FITRY BIN ZAINAL ABIDIN, University of Malaya
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2023418-12366
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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