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临床试验/NCT05291832
NCT05291832已完成不适用

A Randomized, Double-Blind, Placebo-Controlled Study to Explore Perioperative Functional Audio for Anxiety and Cognitive Recovery From Propofol Anaesthesia in Patients Undergoing Endoscopic Procedures

Brain.fm, Inc.1 个研究点 分布在 1 个国家目标入组 329 人开始时间: 2022年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
329
试验地点
1
主要终点
Patient experience

研究概览

简要总结

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).

详细描述

INTRODUCTION

Can perioperative music improve the patient experience, and speed recovery from propofol anaesthesia?

Difficulties around induction and emergence from general anesthesia are a burden on healthcare workers, and central to a patient's experience. Anxiety prior to a procedure, and confusion upon regaining consciousness, are common experiences that negatively affect both patients and staff. Presurgical anxiety can result in difficulty with intubation and longer presurgical delay periods, burdening nurses and slowing the pace of care. Postsurgically, the duration and quality of a patient's recovery from anesthesia affects healthcare providers and patients, both of whom want to minimize the time spent in the recovery room. Lengthy recovery periods may involve amnesic episodes, delirium, agitation, cognitive dysfunction or other emergence phenomenon, which place strain on patients and staff. Longer recoveries also place strain on the patient's caretaker (e.g., relatives waiting to take them home) and burden the healthcare facility, which may be limited in how quickly procedures can occur based on space available in the recovery area.

Perioperative music has been used effectively to control anxiety and pain (Bringman et al. 2009, Gooding et al. 2012, Tan et al. 2012, Fu et al. 2019,. 2020, 2021), but in these studies the music is chosen to be either relaxing or familiar, with no regard for how it drives brain activity. Prior work has focused on the pre-operative period, and has not considered how stimulative music might be used to kickstart cognition following emergence from anaesthesia. Binaural beats (a type of sound therapy that drives neural entrainment) has been recommended for perioperative use (Padmanabhan et al. 2012), but for relaxation only rather than stimulation. Indeed, no work has been done to distinguish music for induction and emergence, or to provide stimulative music to aid recovery from the unconscious state.

Sound is a powerful neuromodulator, and the auditory system can be used to drive neural activity conducive to a variety of mental states. Part of this effect may be due to how sound (and some music in particular) affects neural oscillations (Will & Berg 2007, Large 2010, Tierney et al. 2014), arousal systems (Thompson et al. 2001, Dillman et al. 2007, Gingras et al. 2014) and dopamine levels (Suttoo et al. 2004, Moraes et al. 2018). Propofol recovery is known to be accelerated by activating the brain's arousal systems via drugs (Chemali et al. 2012) or direct electrical stimulation (Bastos et al. 2021), and music targeting arousal is used to improve cognitive function in humans (Gupta et al. 2018, Woods et al. 2021). Auditory stimulation developed specifically to drive the brain in different ways (Brain.fm music) may be useful perioperatively, and different music may be useful for induction and emergence from anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Conditions are randomly assigned by computer and coded ('A' vs 'B'), where the condition identity is unknown until after data analysis is complete

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Opt-in based on recruitment materials.
  • •English speaking
  • •Able to consent

排除标准

  • •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)

研究组 & 干预措施

Brain.fm Music

Experimental

Music with rhythmic amplitude modulation designed to drive neural oscillations.

干预措施: Brain.fm Music (Other)

Spectrally-matched Noise

Active Comparator

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

干预措施: Spectrally-matched Noise (Other)

结局指标

主要结局

Patient experience

时间窗: 60 mins

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." \[Responses as 0-10 horizontal sliders; 0 = Strongly disagree, 5 = Neither Agree nor Disagree, 10 = Strongly Agree\]

Time to cognitive recovery and discharge

时间窗: 60 mins

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.

次要结局

未报告次要终点

研究者

发起方
Brain.fm, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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