Perioperative Audio for Anaesthesia
Completed · Not applicable
Conditions studied: Anesthesia
In brief
Induction and emergence from propofol can be a difficult process for patients and healthcare workers, and long recovery times in particular can limit the rate of care. A double-blinded randomized controlled trial with 220 patients undergoing elective colonoscopy or endoscopy is proposed to test the impact of perioperative music on patient experience and recovery from propofol anaesthesia. Patients will be assigned at random to hear either rhythmic auditory stimulation (music designed to drive neural oscillations) or spectrally-matched noise (sound that produces the same levels of activity at the cochlea but not expected to drive neural entrainment). Bone-conduction headphones will be administered in pre-operation waiting and will play music (or matched noise) until propofol administration ceases, at which time the music (or noise) will be switched: Pre- and post-operational music is designed to be sedative and stimulative, respectively, created with methods that drive auditory entrainment to promote those states. Outcome measures will be recovery time and the patient's subjective experience (taken via survey).
Key facts
- Study ID
- NCT05291832
- Run by
- Brain.fm, Inc.
- People needed
- 329
- Starts
- 2022-02-22
- Expected to finish
- 2022-07-19
- Last updated by the study team
- 2022-08-08
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Opt-in based on recruitment materials.
- English speaking
- Able to consent
You may not qualify if…
- Adverse history to anaesthesia
- Cochlear implants
- Hearing aids
- Adverse/unexpected reaction to procedure/anesthesia (post-hoc)
- Headphones accidentally removed during the study period (post-hoc), for example: Data is excluded if playback is stopped before the audio is switched (indicating patient-initiated removal in pre-op); Data is excluded if playback is stopped before wakefulness is noted (indicating accidental removal of headphones)
Where it is running
- Digestive Health Center of Plano — Plano, Texas, United States
Full record on ClinicalTrials.gov
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