Perioperative Audio for Anaesthesia

NCT05291832 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Anesthesia

Keywords

Music; Anxiety; Recovery

Outcome Measures

Primary Outcomes (2)

• Time to cognitive recovery and discharge

  The time spent in PACU (post-anaesthesia care unit) indicates how quickly patients recovered from propofol anaesthesia. Wakefulness (opening eyes) is noted with a button on the iPad. Audio is to be stopped if headphones are removed. Instead of formal discharge time, nurses are instructed to recover the equipment (iPad) during discharge and end the patient's session (with a button on the iPad). These times logged by the iPad should be coincident with discharge times.

  60 mins

• Patient experience

  When either the patient asks to remove the headphones or is ready to leave the PACU, staff retrieve the headphones and press 'stop' on the iPad. This will advance the screen to a three-question survey, which can be completed by the patient at any time between that point and when they leave the PACU. The questions asked are as follows: (1) "I felt anxious immediately before my procedure.", (2) "I feel energized and alert now (following my procedure).", (3) "I would recommend auditory stimulation during this kind of procedure (over one without audio) to friends and family." \[Responses as 0-10 horizontal sliders; 0 = Strongly disagree, 5 = Neither Agree nor Disagree, 10 = Strongly Agree\]

  60 mins

Study Arms (2)

Brain.fm Music

EXPERIMENTAL

Music with rhythmic amplitude modulation designed to drive neural oscillations.

Other: Brain.fm Music

Spectrally-matched Noise

ACTIVE COMPARATOR

Noise shaped to have the same frequency spectrum (i.e., input level across the cochlea) as the Music condition.

Other: Spectrally-matched Noise

Interventions

Brain.fm Music OTHER

Experimental arm

Brain.fm Music

Spectrally-matched Noise OTHER

Active control arm

Spectrally-matched Noise

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Brain.fm, Inc.: lead
• Envision Healthcare: collaborator

Study Sites (1)

Digestive Health Center of Plano

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Conditions are randomly assigned by computer and coded ('A' vs 'B'), where the condition identity is unknown until after data analysis is complete
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: February 22, 2022
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

US (1)