Auditory Intraoperative Stimulation Effects on Pain and Agitation at Awakening (AUDIOPAW)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-08-24

Brief Summary

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Adenotonsillectomy (AT) is one of the most common pediatric surgical procedures. The management of postoperative pain and agitation after AT is still a controversial issue. Safety considerations limit the use of opioids and non-steroidal anti-inflammatory drugs, leading to inadequate control of the high levels of postoperative pain experienced by AT patients. Along with pain killers, non-pharmacological strategies have remarkable impact on pain management in children. A systematic review and meta-analysis published in The Lancet in 2015 on adult patients suggest that auditory stimulation with music in the perioperative setting, and even when patients are under general anaesthesia, can reduce postoperative pain, anxiety, and analgesia needs. The authors concluded that there is sufficient evidence to implement auditory stimulation in the treatment of all adult surgical patients, regardless of the mode of administration. Up to now, no research has investigated the effects of intraoperative auditory stimulation on pain and agitation upon awakening after AT in the pediatric population. Objective of this study is to determine the effects of intraoperative auditory stimulation on pain and agitation upon awakening after pediatric AT.

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Detailed Description

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Conditions

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Procedural Anxiety Procedural Pain Adenotonsillitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Auditory stimulation 1 (Music)

45 deciBel Sensation Level (dB SL), normalized, high-frequency sampled W.A. Mozart Symphony n°4 in D K19 and n°5 in B-flat K22 (from Mozart Symphonies Vol. I - Adam Fisher, Dacapo Records, Frederiksberg C., Denmark, 2013)

Group Type EXPERIMENTAL

Music

Intervention Type BEHAVIORAL

45 dB SL, normalized, high-frequency sampled W.A. Mozart Symphony n°4 in D K19 and n°5 in B-flat K22 (from Mozart Symphonies Vol. I - Adam Fisher, Dacapo Records, Frederiksberg C., Denmark, 2013)

Auditory stimulation 2 (Mother's lap)

45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped

Group Type EXPERIMENTAL

Mother's lap

Intervention Type BEHAVIORAL

45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped

Soundproof earplugs

Disposable foam earplugs with a noise attenuation of at least 30 deciBel (dB)

Group Type EXPERIMENTAL

Soundproof earplugs

Intervention Type BEHAVIORAL

Disposable foam earplugs with a noise attenuation of at least 30 dB

No stimulation

Current standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music

45 dB SL, normalized, high-frequency sampled W.A. Mozart Symphony n°4 in D K19 and n°5 in B-flat K22 (from Mozart Symphonies Vol. I - Adam Fisher, Dacapo Records, Frederiksberg C., Denmark, 2013)

Intervention Type BEHAVIORAL

Mother's lap

45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped

Intervention Type BEHAVIORAL

Soundproof earplugs

Disposable foam earplugs with a noise attenuation of at least 30 dB

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age 2 to 17 years old
* scheduled for adenotonsillectomy
* recent audiometry and tympanometry evaluation (\<1 month)

Exclusion Criteria

* no informed consent
* other combined surgical procedures
* comorbidities (e.g. congenital anomalies of the head-and-neck, psychomotor delay, autism spectrum disorders)
* American Society of Anesthesiologists (ASA) Classification score \>2
* ongoing chronic pharmacological therapy
* first language not Italian
* environmental noise exceeding limits in the operating room

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No