## Protocol Section
### Identification Module
**NCT ID:** NCT04112979

**Acronym:** AUDIOPAW

**Brief Title:** Auditory Intraoperative Stimulation Effects on Pain and Agitation at Awakening (AUDIOPAW)

**Official Title:** Effects of Intraoperative Auditory Stimulation on Pain and Agitation at Awakening After Pediatric Adenotonsillectomy - 4 Arms, Double-blinded, Randomized, Controlled Clinical Trial

#### Organization Study ID Info
**ID:** RC 36/18
#### Organization
**Class:** OTHER
**Full Name:** IRCCS Burlo Garofolo
### Status Module
#### Completion Date
**Date:** 2019-08-24

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-10-02

**Type:** ACTUAL

**Last Update Submit Date:** 2019-10-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-08-23

**Type:** ACTUAL

#### Start Date
**Date:** 2018-03-01

**Type:** ACTUAL

**Status Verified Date:** 2019-10

#### Study First Post Date
**Date:** 2019-10-02
**Type:** ACTUAL
**Study First Submit Date:** 2019-08-06
**Study First Submit QC Date:** 2019-10-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** IRCCS Burlo Garofolo

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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 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 Module

**Conditions:**

- Procedural Anxiety

- Procedural Pain

- Adenotonsillitis

**Keywords:**

- Auditory stimulation

- adenotonsillectomy

- pain

- agitation

- awakening

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 115

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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)

**Intervention Names:**

- Behavioral: Music

**Label:** Auditory stimulation 1 (Music)

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: Mother's lap

**Label:** Auditory stimulation 2 (Mother's lap)

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Behavioral: Soundproof earplugs

**Label:** Soundproof earplugs

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Current standard of care

**Label:** No stimulation

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Auditory stimulation 1 (Music)

**Description:** 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)

**Name:** Music

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Auditory stimulation 2 (Mother's lap)

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

**Name:** Mother's lap

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Soundproof earplugs

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

**Name:** Soundproof earplugs

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** Pain score (Face, Legs, Activity, Cry, Consolability scale), evaluated by parents (for children <=3 years)

**Time Frame:** Within 10 minutes after awakening

**Description:** 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.

**Measure:** 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

#### Secondary Outcomes

**Description:** Evaluated using the Paediatric Anesthesia Emergence Delirium (PAED) scale, ranging form 0 to 20. Higher scores correspond to higher levels of agitation.

**Measure:** Agitation

**Time Frame:** Within 10 minutes after awakening

**Description:** Number of postoperative pain killers drugs administered

**Measure:** Frequency of use of pain killer drugs

**Time Frame:** Within 6 hours after the awakening

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 17 Years

**Minimum Age:** 2 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Trieste

**Country:** Italy

**Facility:** Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

**Zip:** 34137

#### Overall Officials

**Official 1:**

**Affiliation:** IRCCS Burlo Garofolo

**Name:** Enrico Muzzi, MD

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** 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.

**PMID:** 34014258

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020820

- Term: Dyskinesias

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000011596

- Term: Psychomotor Disorders

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000096762

- Term: Aberrant Motor Behavior in Dementia

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000010146

- Term: Pain

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M1219

- Name: Pain, Procedural

- Relevance: HIGH

- As Found: Procedural Pain

- ID: M14452

- Name: Psychomotor Agitation

- Relevance: HIGH

- As Found: Agitation

- ID: M22574

- Name: Dyskinesias

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M14453

- Name: Psychomotor Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M3259

- Name: Aberrant Motor Behavior in Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011595

- Term: Psychomotor Agitation

- ID: D000073818

- Term: Pain, Procedural

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M251057

- Name: TEMPO

- Relevance: LOW

- As Found: Unknown

- ID: M186190

- Name: Aluminum hydroxide, magnesium hydroxide, simethicone drug combination

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
