Music Therapy During Pediatric Extubation Readiness Trials

NCT02845947 | Completed DMC

• 1 other identifier: HS16-0478
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to research the effects of music therapy during pediatric extubation readiness trials. Amount of sedation, physiological measures, and parent/staff satisfaction surveys will be measured.

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (5)

• Music Therapy will aid in the success of extubation readiness trials as measured by physiological measures.

  A data collection tool (created by the PI's) will be used to record physiological signs (heart rate and blood pressure) by a Registered Nurse (RN) every 15 minutes. The heart rate will be captured from an Intensive Care Unit monitor and the blood pressure will be measured by a blood pressure cuff administered by a RN.

  Through study completion, an average of 1 year.

• Music Therapy will aid in the success of extubation readiness trials as measured by sedation bolus requirements.

  A data collection tool (created by the PI's) will be used to record sedation bolus requirements (mcg/kg) every 15 minutes throughout the length of the extubation readiness trial. This will be administered and recorded by an RN.

  Through study completion, an average of 1 year.

• Music Therapy will aid in the success of extubation readiness trials as measured by agitation levels.

  A data collection tool (created by the PI's) will be used to record agitation levels (using the State Behavioral Scale for Mechanically Ventilated Patients) every 15 minutes throughout the length of the extubation readiness trial.

  Through study completion, an average of 1 year.

• Music Therapy will reduce anxiety of physicians and nurses during the extubation readiness trial.

  A survey (authored by the PI's) will be provided to physicians and nurses rating their anxiety score based on a 5-point Likert scale.

  Through study completion, an average of 1 year.

• Music Therapy will reduce anxiety of parents/guardiansduring the extubation readiness trial.

  A survey (authored by the PI's) will be provided to parents/guardians rating their anxiety score based on a 5-point Likert scale.

  Through study completion, an average of 1 year.

Study Arms (2)

Music Therapy

EXPERIMENTAL

Music Therapy to be provided for pediatric patients undergoing extubation readiness trial

Behavioral: Music Therapy

Control

NO INTERVENTION

Patients undergoing standard extubation readiness trial

Interventions

Music Therapy BEHAVIORAL

The music therapy intervention offered during the time of the patient's extubation readiness trial (ERT) will consist of live music using a multitude of instruments and patient-preferred and improvised music. The music therapy interventions will always include the use of live music, including guitar, keyboard, voice, ocean drum, reverie harp, and/or various percussive instruments. The music therapist will use a tablet to understand how to play patient-preferred songs. To ensure patient safety, the music therapist will adhere to the infection control policies set forth by the institution. The following are the intended goals of the Music therapy intervention: facilitating relaxation, alleviation of anxiety, and successful utilization of new coping skills.

Music Therapy

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients 0-18 years of age admitted to the pediatric intensive care unit, regardless of cognitive status
• Patients admitted receiving endotracheal mechanical ventilation

You may not qualify if:

• Patients receiving extubation for withdrawal of care, patients with known/documented hearing loss/deafness.
• Patients on mechanical ventilation not scheduled for planned ERT.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Cohen Children's Medical Center

New Hyde Park, New York, 11040, United States

Location

Related Publications (20)

• Bradt J, Dileo C. Music interventions for mechanically ventilated patients. Cochrane Database Syst Rev. 2014;2014(12):CD006902. doi: 10.1002/14651858.CD006902.pub3. Epub 2014 Dec 9.

  PMID: 25490233 BACKGROUND

• Thomas LA. Clinical management of stressors perceived by patients on mechanical ventilation. AACN Clin Issues. 2003 Feb;14(1):73-81. doi: 10.1097/00044067-200302000-00009.

  PMID: 12574705 BACKGROUND

• Wong HL, Lopez-Nahas V, Molassiotis A. Effects of music therapy on anxiety in ventilator-dependent patients. Heart Lung. 2001 Sep-Oct;30(5):376-87. doi: 10.1067/mhl.2001.118302.

  PMID: 11604980 BACKGROUND

• Chlan LL. Description of anxiety levels by individual differences and clinical factors in patients receiving mechanical ventilatory support. Heart Lung. 2003 Jul-Aug;32(4):275-82. doi: 10.1016/s0147-9563(03)00096-7.

  PMID: 12891169 BACKGROUND

• Chlan LL. Relationship between two anxiety instruments in patients receiving mechanical ventilatory support. J Adv Nurs. 2004 Dec;48(5):493-9. doi: 10.1111/j.1365-2648.2004.03231.x.

  PMID: 15533087 BACKGROUND

• Lee OK, Chung YF, Chan MF, Chan WM. Music and its effect on the physiological responses and anxiety levels of patients receiving mechanical ventilation: a pilot study. J Clin Nurs. 2005 May;14(5):609-20. doi: 10.1111/j.1365-2702.2004.01103.x.

  PMID: 15840076 BACKGROUND

• Chlan L, Savik K. Patterns of anxiety in critically ill patients receiving mechanical ventilatory support. Nurs Res. 2011 May-Jun;60(3 Suppl):S50-7. doi: 10.1097/NNR.0b013e318216009c.

  PMID: 21543962 BACKGROUND

• Li DT, Puntillo K. A pilot study on coexisting symptoms in intensive care patients. Appl Nurs Res. 2006 Nov;19(4):216-9. doi: 10.1016/j.apnr.2006.01.003.

  PMID: 17098160 BACKGROUND

• Hofhuis JG, Spronk PE, van Stel HF, Schrijvers AJ, Rommes JH, Bakker J. Experiences of critically ill patients in the ICU. Intensive Crit Care Nurs. 2008 Oct;24(5):300-13. doi: 10.1016/j.iccn.2008.03.004. Epub 2008 May 9.

  PMID: 18472265 BACKGROUND

• Gabor JY, Cooper AB, Crombach SA, Lee B, Kadikar N, Bettger HE, Hanly PJ. Contribution of the intensive care unit environment to sleep disruption in mechanically ventilated patients and healthy subjects. Am J Respir Crit Care Med. 2003 Mar 1;167(5):708-15. doi: 10.1164/rccm.2201090.

  PMID: 12598213 BACKGROUND

• Chlan L. A review of the evidence for music intervention to manage anxiety in critically ill patients receiving mechanical ventilatory support. Arch Psychiatr Nurs. 2009 Apr;23(2):177-9. doi: 10.1016/j.apnu.2008.12.005.

  PMID: 19327560 BACKGROUND

• Hunter BC, Oliva R, Sahler OJ, Gaisser D, Salipante DM, Arezina CH. Music therapy as an adjunctive treatment in the management of stress for patients being weaned from mechanical ventilation. J Music Ther. 2010 Fall;47(3):198-219. doi: 10.1093/jmt/47.3.198.

  PMID: 21275332 BACKGROUND

• Korhan EA, Khorshid L, Uyar M. The effect of music therapy on physiological signs of anxiety in patients receiving mechanical ventilatory support. J Clin Nurs. 2011 Apr;20(7-8):1026-34. doi: 10.1111/j.1365-2702.2010.03434.x. Epub 2011 Feb 16.

  PMID: 21323778 BACKGROUND

• Hetland B, Lindquist R, Chlan LL. The influence of music during mechanical ventilation and weaning from mechanical ventilation: A review. Heart Lung. 2015 Sep-Oct;44(5):416-25. doi: 10.1016/j.hrtlng.2015.06.010. Epub 2015 Jul 27.

  PMID: 26227333 BACKGROUND

• Johnson MM, Sexton DL. Distress during mechanical ventilation: patients' perceptions. Crit Care Nurse. 1990 Jul-Aug;10(7):48-57. No abstract available.

  PMID: 2403412 BACKGROUND

• Loomba RS, Arora R, Shah PH, Chandrasekar S, Molnar J. Effects of music on systolic blood pressure, diastolic blood pressure, and heart rate: a meta-analysis. Indian Heart J. 2012 May-Jun;64(3):309-13. doi: 10.1016/S0019-4832(12)60094-7.

  PMID: 22664817 BACKGROUND

• Tracy MF, Chlan L. Nonpharmacological interventions to manage common symptoms in patients receiving mechanical ventilation. Crit Care Nurse. 2011 Jun;31(3):19-28. doi: 10.4037/ccn2011653.

  PMID: 21632591 BACKGROUND

• Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670.

  PMID: 23689789 BACKGROUND

• Davis T, Jones P. Music therapy: decreasing anxiety in the ventilated patient: a review of the literature. Dimens Crit Care Nurs. 2012 May-Jun;31(3):159-66. doi: 10.1097/DCC.0b013e31824dffc6.

  PMID: 22475701 BACKGROUND

• Azoulay E, Chaize M, Kentish-Barnes N. Involvement of ICU families in decisions: fine-tuning the partnership. Ann Intensive Care. 2014 Nov 30;4:37. doi: 10.1186/s13613-014-0037-5. eCollection 2014.

  PMID: 25593753 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shawna N Vernisie, MA

  Northwell Health

  PRINCIPAL INVESTIGATOR

• James B Schneider, MD

  Intensivist

  PRINCIPAL INVESTIGATOR

• Mary Schafer, BSN

  Northwell Health

  PRINCIPAL INVESTIGATOR

• Peter Silver, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Licensed Creative Arts Therapist - Music Therapist

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 27, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)