Binaurale beats for reduksjon av postoperativ smerte og angst
Binaurale beats kontra musikk etter eget valg for tidlig postoperativ smerte etter ambulant totalt kneledd og totalt hofteartroplastikk: En randomisert kontrollert studie
To deliver a 30-minute binaural beats audio intervention in PACU and collect pain and anxiety outcomes immediately following surgery, and 4 hours following surgery completion in adults undergoing ambulatory total knee arthroplasty and total hip arthroplasty (TKA and THA).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Andrew R Moya, MD
- Telefonnummer: 1786-856-6463
- E-post: arm577@miami.edu, doc.a.moya1@gmail.com
Studiesteder
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Florida
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Miami, Florida, Forente stater, 33132
- Rekruttering
- Univeristy of Miami Health System
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Hovedetterforsker:
- Victor H Hernandez, MD
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Ta kontakt med:
- Andrew R Moya, MD
- Telefonnummer: 786-856-6463
- E-post: arm577@miami.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- American Society of Anesthesiologists Physical Status Classification System (ASA) 1-3
- Spinal anesthesia
- Patients receiving nerve-block in Post-Anesthesia Care Unit (PACU)
- Primary total hip or total knee arthroplasty
Exclusion Criteria:
- Moderate-severe hearing impairment or use of hearing aids
- History of significant tinnitus, active delirium, chronic high-dose opioid therapy (>60 MME/day baseline)
- Major psychiatric pathology
- General anesthesia
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Binaural Beats (BB)
Participants assigned to this arm will listen to a 30-minute binaural beats audio session at a comfortable volume through standardized over-ear headphones while in the post-anesthesia care unit (PACU). The audio will use a primary target frequency of 10 Hz (alpha range), created using soft sine-wave carriers in the 200-600 Hz range that generate a 10 Hz interaural difference (e.g., 400 Hz left ear / 410 Hz right ear). Volume will be set at a comfortable conversational level (~55-65 dBA) and may be adjusted by the participant. The session will begin within 15 minutes of PACU arrival. Participants may stop the audio at any time. |
30-minute binaural beats audio session targeting 400 and 410 hertz (Hz) alpha 400 hertz (Hz) in one ear 410 hertz (Hz) in other ear frequency delivered through standardized headphones in the PACU. |
|
Aktiv komparator: Music of Choice (MOC)
Participants in this arm will receive usual postoperative care in the post-anesthesia care unit (PACU) and may listen to music of their choice using standardized headphones. They will select their preferred music and listen for 30 minutes at a comfortable volume (~55-65 dBA), which they may adjust as needed. No binaural beat frequencies will be used. Music listening is optional and may be stopped at any time. |
Usual postoperative care in addition to patient-selected music using standardized headphones |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pain Score Numeric Pain Rating Scale (NPRS)
Tidsramme: Baseline (pre-operative) to 4 hours post-operation.
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Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS), a validated 0-10 scale where 0 = no pain and 10 = worst imaginable pain. Change will be calculated as the difference between the pre-operative NPRS score and the NPRS score obtained 4 hours after surgery. Higher scores indicate greater pain intensity. |
Baseline (pre-operative) to 4 hours post-operation.
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Change in Anxiety Score State-Trait Anxiety Inventory (STAI-S)
Tidsramme: Baseline (pre-operative) to 4 hours post-operation.
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Anxiety will be measured using the State-Trait Anxiety Inventory - State Subscale (STAI-S). The STAI-S consists of 20 items scored from 1 to 4, producing a total score range of 20-80, with higher scores indicating greater state anxiety. Change will be calculated as the difference between the pre-operative STAI-S score and the STAI-S score obtained 4 hours after surgery. |
Baseline (pre-operative) to 4 hours post-operation.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Opioid Consumption in the Post-Anesthesia Care Unit (PACU) (MME)
Tidsramme: From PACU arrival (time 0) until PACU discharge (typically 1-4 hours post-operation)
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Total opioid use administered during the post-anesthesia care unit (PACU) stay will be recorded, including all intravenous and oral opioid medications. All doses will be converted to morphine milligram equivalents (MME) using standard Centers for Disease Control and Prevention (CDC) conversion factors. Unit of Measure: Morphine milligram equivalents (MME) |
From PACU arrival (time 0) until PACU discharge (typically 1-4 hours post-operation)
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Postoperative Vital Signs Heart Rate
Tidsramme: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
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Heart rate (beats per minute) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record. |
Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
|
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Patient Satisfaction Score
Tidsramme: Measured once during the PACU stay, at the earliest feasible time point up to 4 hours post-operation
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Patient satisfaction with the postoperative experience will be measured using a 5-point Likert scale, where 1 = very dissatisfied and 5 = very satisfied. Unit of Measure: Likert score (1-5) |
Measured once during the PACU stay, at the earliest feasible time point up to 4 hours post-operation
|
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Postoperative Vital Signs Blood Pressure
Tidsramme: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
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Systolic and diastolic blood pressure (millimeters of mercury) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record. |
Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
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Postoperative Vital Signs Respiratory Rate
Tidsramme: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
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Respiratory rate (breaths per minute) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record. |
Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Victor H Hernandez, MD, MSc, University of Miami
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20251389
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