Procedural AnxietyAUDIOPAWNCT04112979
Auditory Intraoperative Stimulation Effects on Pain and Agitation at Awakening (AUDIOPAW)
A study testing Music, Mother's lap and Soundproof earplugs in people with Procedural Anxiety and Procedural Pain, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Procedural Anxiety, Procedural Pain, Adenotonsillitis
- What is being tested?
- Music, Mother's lap and Soundproof earplugs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2018to 24 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 2 to 17 years old
- scheduled for adenotonsillectomy
- recent audiometry and tympanometry evaluation (<1 month)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Trieste, 34137
About this study
Official title: Effects of Intraoperative Auditory Stimulation on Pain and Agitation at Awakening After Pediatric Adenotonsillectomy - 4 Arms, Double-blinded, Randomized, Controlled Clinical Trial
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.
- Conditions
- Procedural Anxiety, Procedural Pain, Adenotonsillitis
- Being tested
- Music, Mother's lap, Soundproof earplugs
- Keywords
- Auditory stimulation, adenotonsillectomy, pain, agitation, awakening
- Medical subject headings
- Pain, Procedural, Pain, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
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)
Mother's lapBehavioural
45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped
Soundproof earplugsBehavioural
Disposable foam earplugs with a noise attenuation of at least 30 dB
| Study group | Role | What they receive |
|---|---|---|
| Auditory stimulation 1 (Music) | Experimental | 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) Receives: Behavioral: Music |
| Auditory stimulation 2 (Mother's lap) | Experimental | 45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped Receives: Behavioral: Mother's lap |
| Soundproof earplugs | Experimental | Disposable foam earplugs with a noise attenuation of at least 30 deciBel (dB) Receives: Behavioral: Soundproof earplugs |
| No stimulation | No intervention | Current standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score (Wong-Baker Faces Pain Rating Scale), self-administered (collaborative children between 3 and 8 years)
Pain score for collaborative children between 3 and 8 years will be evaluated with the self-administered Wong-Baker Faces Pain Rating scale, ranged 0-10.
Higher scores correspond to higher levels of pain.
Measured: Within 10 minutes after awakening
Pain score (Visual Analogue Scale), self-administered (collaborative children >=8 years) or administered by parents (non-collaborative children >=8 years)
Pain score for >=8 years old children will be evaluated with Visual Analogue Scale (self administered if collaborative; administered by parents if non-collaborative children), ranged 0-10.
Higher scores correspond to higher levels of pain.
In accordance with previous studies (Ferreira-Valente et al. Validity of four pain intensity rating scales. Pain 2011;152:2399-2404), the scores of Wong-Baker Faces Pain Rating scale and Visual Analogue Scale will be considered comparable and combined in one outcome variable.
Measured: Within 10 minutes after awakening
Pain score (Face, Legs, Activity, Cry, Consolability scale), evaluated by parents (for children <=3 years)
For children <=3 years, pain score will be evaluated by parents using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, ranged 0-10.
Higher scores correspond to higher levels of pain.
Measured: Within 10 minutes after awakening
Pain score (Children's Hospital of Eastern Ontario Pain scale), evaluated by parents (for non-collaborative children between 3 and 7 years)
For non-collaborative children between 3 and 7 years, pain score will be evaluated by parents using the Children's Hospital of Eastern Ontario Pain (CHEOPS) scale, ranged 0-10.
Higher scores correspond to higher levels of pain.
In accordance with previous studies, the scores of the Face, Legs, Activity, Cry, Consolability (FLACC) scale and of the Children's Hospital of Eastern Ontario Pain (CHEOPS) scale will be considered comparable and combined in one outcome variable.
Measured: Within 10 minutes after awakening
Secondary outcomes (2)
Agitation
Evaluated using the Paediatric Anesthesia Emergence Delirium (PAED) scale, ranging form 0 to 20. Higher scores correspond to higher levels of agitation.
Measured: Within 10 minutes after awakening
Frequency of use of pain killer drugs
Number of postoperative pain killers drugs administered
Measured: Within 6 hours after the awakening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Mar 2018
- Primary completion23 Aug 2019
- Study completion24 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Procedural AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrico Muzzi, MD, Study chair, IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112979
- Sponsor's protocol ID
- RC 36/18
- Acronym
- AUDIOPAW
- Status last verified
- Oct 2019
- First submitted
- 6 Aug 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muzzi E, Ronfani L, Bossini B, Lezcano C, Orzan E, Barbi E. Effects of Intraoperative Auditory Stimulation on Pain and Agitation on Awakening After Pediatric Adenotonsillectomy: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Jul 1;147(7):638-645. doi: 10.1001/jamaoto.2021.0870.
PubMed 34014258
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraoperative Auditory Stimulation on Pain and Agitation at Awakening After Pediatric Adenotonsillectomy - 4 Arms, Double-blinded, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04112979
- Acronym / sponsor ID
- AUDIOPAW / RC 36/18
- Conditions
- Procedural Anxiety, Procedural Pain, Adenotonsillitis
- Keywords
- Auditory stimulation, adenotonsillectomy, pain, agitation, awakening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 24 Aug 2019 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Auditory stimulation 1 (Music) | Experimental | Behavioral: Music45 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) |
| Auditory stimulation 2 (Mother's lap) | Experimental | Behavioral: Mother's lap45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped |
| Soundproof earplugs | Experimental | Behavioral: Soundproof earplugsDisposable foam earplugs with a noise attenuation of at least 30 deciBel (dB) |
| No stimulation | No intervention | –Current standard of care |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age 2 to 17 years old
- scheduled for adenotonsillectomy
- recent audiometry and tympanometry evaluation (<1 month)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music45 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) | Behavioural | Auditory stimulation 1 (Music) |
| Mother's lap45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped | Behavioural | Auditory stimulation 2 (Mother's lap) |
| Soundproof earplugsDisposable foam earplugs with a noise attenuation of at least 30 dB | Behavioural | Soundproof earplugs |
Primary outcome
Pain score (Wong-Baker Faces Pain Rating Scale), self-administered (collaborative children between 3 and 8 years)
Time frame: Within 10 minutes after awakening
Pain score for collaborative children between 3 and 8 years will be evaluated with the self-administered Wong-Baker Faces Pain Rating scale, ranged 0-10. Higher scores correspond to higher levels of pain.
Pain score (Visual Analogue Scale), self-administered (collaborative children >=8 years) or administered by parents (non-collaborative children >=8 years)
Time frame: Within 10 minutes after awakening
Pain score for >=8 years old children will be evaluated with Visual Analogue Scale (self administered if collaborative; administered by parents if non-collaborative children), ranged 0-10. Higher scores correspond to higher levels of pain. In accordance with previous studies (Ferreira-Valente et al. Validity of four pain intensity rating scales. Pain 2011;152:2399-2404), the scores of Wong-Baker Faces Pain Rating scale and Visual Analogue Scale will be considered comparable and combined in one outcome variable.
Pain score (Face, Legs, Activity, Cry, Consolability scale), evaluated by parents (for children <=3 years)
Time frame: Within 10 minutes after awakening
For children <=3 years, pain score will be evaluated by parents using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, ranged 0-10. Higher scores correspond to higher levels of pain.
Pain score (Children's Hospital of Eastern Ontario Pain scale), evaluated by parents (for non-collaborative children between 3 and 7 years)
Time frame: Within 10 minutes after awakening
For non-collaborative children between 3 and 7 years, pain score will be evaluated by parents using the Children's Hospital of Eastern Ontario Pain (CHEOPS) scale, ranged 0-10. Higher scores correspond to higher levels of pain. In accordance with previous studies, the scores of the Face, Legs, Activity, Cry, Consolability (FLACC) scale and of the Children's Hospital of Eastern Ontario Pain (CHEOPS) scale will be considered comparable and combined in one outcome variable.
2 secondary outcomes
Agitation
Time frame: Within 10 minutes after awakening
Frequency of use of pain killer drugs
Time frame: Within 6 hours after the awakening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Derived from this study: PubMed 34014258Muzzi E, Ronfani L, Bossini B, Lezcano C, Orzan E, Barbi E. Effects of Intraoperative Auditory Stimulation on Pain and Agitation on Awakening After Pediatric Adenotonsillectomy: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Jul 1;147(7):638-645. doi: 10.1001/jamaoto.2021.0870.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrico Muzzi, MD study chair
IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music, Mother's lap and Soundproof earplugs in people with Procedural Anxiety and Procedural Pain, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (Wong-Baker Faces Pain Rating Scale), self-administered (collaborative children between 3 and 8 years) (time frame: Within 10 minutes after awakening). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04112979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.