- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01669733
The Effects of Perioperative Music Therapy on Women Undergoing Breast Biopsy Surgery
The purpose of this research is to study the effect music has on women undergoing surgical breast biopsy. Through the facilitation of live and/or recorded music listening, we will examine the perception of patient anxiety, the total amount of propofol required to obtain a BIS reading of 70, and recovery time in the PACU. We will also collect data and evaluate the effect of live and/or recorded music on patient satisfaction. It is hypothesized that:
- Patients in the live and recorded music groups will experience less anxiety than the non-music (standard care) group.
- Patients in the live and recorded music groups will experience a reduction in the amount of anesthesia needed to reach a state of moderate sedation compared to the non-music (standard care) group.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Music therapy's effect on anxiety in Preoperative.(live vs. recorded):
If the patient is randomly selected to the live music group, the music therapist will prepare a preferred song to be performed live in the preoperative room. If the patient is randomly selected for the recorded music group, she will be given an iPod and headphones and will listen to a recorded version of her preferred song. If the patient is randomly selected for the control group, she will receive standard care and no music. Pre/posttests will be given using a Global Anxiety Visual Analog Scale (GA-VAS).
Music therapy's effect on propofol requirements intraoperatively:
Subjects in the live music group and subjects in the recorded music group will listen to recorded music intraoperatively. All subjects will receive equal amounts of fentanyl and versed. Subjects will receive fentanyl in the amount of 1 microgram per kilogram and versed (midazolam) in the amount of 0.02 milligrams per kilogram from the nurse anesthetist. An ipod with headphones will be given to the subject when she is being prepared to move to the operating room. The board certified music therapist will initiate recorded music (harp selections). Recorded music will be relaxing harp selections. The board certified music therapist will accompany the subject to the operating room and assure volume levels and electronic equipment function properly.
Anesthesia personnel will apply BIS monitor before propofol administration. Anesthesia personnel will titrate propofol to obtain BIS reading of 70 or lower and record the propofol in micrograms per kilogram per minute, infusing at that point. Signal Quality Index (SQI) will be recorded when the BIS reaches 70 to give credibility to the BIS monitor. SQI is a measure of the signal quality for the EEG channel source and is calculated based on impedance data, artifact, and other variables. The total amount of propofol for the case will be recorded as total milligrams received. Anesthesia personnel will record Observer's Assessment of the Alertness/Sedation (OAA/S) when BIS monitor reaches 70 or below as incidental data point. A score of 3 on OAA/S indicates that the patient responds only after mild prodding and shaking. OAA/S will be compared to BIS reading.
Time in PACU and Patient Satisfaction:
Recorded music will continue playing until the subject has met discharge criteria according to University Hospital's policy and procedure. The amount of time between when the patient leaves the operating room and meets discharge criteria (determined by nurse) will be recorded. Patient satisfaction will be recorded using a Likert scale: 7= highly satisfied; 1=not at all satisfied after the subject has met her discharge criteria.
Controls: The control group subjects will receive standard anesthesia, nursing and surgical care. All rating procedures will be the same. Controls will wear noise reducing headphones. The music therapist will not accompany control patients following surgery. When the trial is complete, the music therapist will offer the control subject a CD of the recorded music once she has met discharge criteria and all data is recorded. This will occur for the sake of ethics.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ohio
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Cleveland, Ohio, Stati Uniti, 44118
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Subjects who will undergo surgical breast biopsy under monitored anesthesia care
- English speaking women
- >18 years
- ASA classification of I (no systematic disease) or II (mild to moderate disease who are medically stable) or III (severe systematic disease, not incapacitating)
Exclusion Criteria:
- Patients with profound mental illness
- with developmental disability
- with significant hearing loss where music would not be heard from headphones
- currently taking narcotics
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Live/Recorded Music Group
The music therapist will prepare a preferred song to be performed live in the preoperative room.
Subjects in the live music group will listen to recorded music intraoperatively.
|
Recorded or live music will be played prior to surgery in the preoperative room.
Subjects in the live music group and subjects in the recorded music group will listen to recorded music intraoperatively.
An ipod with headphones will be given to the subject when she is being prepared to move to the operating room.
The board certified music therapist will initiate recorded music (harp selections).
Recorded music will be relaxing harp selections.
The board certified music therapist will accompany the subject to the operating room and assure volume levels and electronic equipment function properly.
Altri nomi:
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Sperimentale: Recorded Music Group
Recorded music group will be given an iPod and headphones and will listen to a recorded version of a preferred song.
|
Recorded or live music will be played prior to surgery in the preoperative room.
Subjects in the live music group and subjects in the recorded music group will listen to recorded music intraoperatively.
An ipod with headphones will be given to the subject when she is being prepared to move to the operating room.
The board certified music therapist will initiate recorded music (harp selections).
Recorded music will be relaxing harp selections.
The board certified music therapist will accompany the subject to the operating room and assure volume levels and electronic equipment function properly.
Altri nomi:
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Comparatore attivo: No Music (Standard of care)
The control group will receive standard of care and no music.
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The control group subjects will receive standard anesthesia, nursing and surgical care.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The cumulative intra-operative dose of propofol(mg) given to each patient
Lasso di tempo: at the time of surgery
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The primary outcome for this study will be the amount of propofol administered intra-operatively.
Each of the groups receiving music pre-operatively and/or peri-operatively will be compared to the control (no music) group.
Anesthesia personnel will apply BIS (Bispectral Index Monitor) monitor before propofol administration.
Anesthesia personnel will titrate propofol to obtain BIS reading of 70 or lower and record the propofol in micrograms per kilogram per minute, infusing at that point.
The total amount of propofol for the case will be recorded as total milligrams received.
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at the time of surgery
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Change in anxiety levels
Lasso di tempo: Pr- and post- music therapy prior to surgery
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Pre/posttests will be given using a Global Anxiety Visual Analog Scale (GA-VAS).
A pretest will be given in the preoperative area before intervention and a posttest will be given after the live song, the recorded song, or five minutes of standard care has occurred.
The investigators will measure the subject's marking (vertical line) on the GA-VAS from the left side of the GA-VAS to the subject's line using millimeters on a ruler.
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Pr- and post- music therapy prior to surgery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Amount of time in the PACU (post-anesthesia care unit)
Lasso di tempo: at time of discharge from PACU
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Amount of time between when the patient leaves the operating room and meets discharge criteria (determined by nurse) using a clock.
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at time of discharge from PACU
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Patient satisfaction to music therapy
Lasso di tempo: at the time of PACU discharge
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Qualitative data will be taken on the subject's subjective comments regarding their thoughts about their surgical experience using a 1-10 Likert Scale.
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at the time of PACU discharge
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Deforia Lane, PhD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CASE5112
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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