Music Therapy During Pediatric Extubation Readiness Trials

Respiratory Insufficiency Clinical Trial

— MTPERT  

Official title:

Music Therapy During Pediatric Extubation Readiness Trials: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845947
• Other study ID #: HS16-0478
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: June 2023

Study information

• Verified date: September 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 start time and duration of the session will be initiated by the attending physician, and the length of music therapy intervention provided will not exceed two and a half hours. The music therapy intervention will continue for 30 minutes post extubation. This time frame was determined in accordance with the institution's weaning trial protocol. Family members involved in the trial, as well as the nurse and physician, will complete a post-procedural survey about the music therapy intervention.

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.

Before the weaning trial, the music therapist will meet with the patient's family to obtain the musical preferences of the patient. During the two hour ERT, the music therapist will play patient-preferred songs on a variety of different instruments to bring about a sense of interpersonal connectedness, normalization, and to enhance adaptive coping. In order to maximize coping and minimize stress/anxiety, the music therapy intervention will be malleable and patient/family centered, responding to the changing needs that present throughout the procedure/weaning process. If the patient becomes more alert throughout the weaning process, the music therapist will adapt the music making based on patient's preferences; at this time, the patient may be able to answer yes/no questions when asked. The music therapist will adjust the volume, timbre, and tempo of the music according to the patient's respiratory rhythms throughout the weaning process and after extubation.

When the live music therapy intervention has completed, the music therapist will follow up with the family members immediately. The investigator will administer and collect the survey from the family, and the music therapist will administer and collect the survey from the nurse and physician.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

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

• Patients admitted receiving endotracheal mechanical ventilation

Exclusion Criteria:

• Patients receiving extubation for withdrawal of care, patients with known/documented hearing loss/deafness.

• Patients on mechanical ventilation not scheduled for planned ERT.

Related Conditions & MeSH terms

• Respiratory Insufficiency

Intervention

Behavioral:
• Music Therapy
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.

Locations

Country	Name	City	State
United States	Cohen Children's Medical Center	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Johnson MM, Sexton DL. Distress during mechanical ventilation: patients' perceptions. Crit Care Nurse. 1990 Jul-Aug;10(7):48-57. No abstract available. Erratum In: Crit Care Nurse 1990 Sep;10(8):72. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.