Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation

NCT00440700 | Completed Phase 2 Results DMC

• 1 other identifier: 0601M79066
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test whether patients who are receiving mechanical ventilation in the ICU who listened to preferred, relaxing music whenever they desire for as long as they desire will have less anxiety, receive fewer medications, stay in the ICU for a shorter time, and experience less stress than patients who do not listen to music.

Conditions

Anxiety

Keywords

Ventilator; chronic obstructive pulmonary disease; Anxiety

Outcome Measures

Primary Outcomes (2)

• Sedative Exposure

  Sedative exposure was measured by: 1) the number (dose frequency) of sedative medication doses administered in a 4-hour time period each day and 2) by an aggregate dose intensity of sedative medications administered in a 4-hour time period each day based on all subjects receiving sedative medications on any individual study day yielding a sedation intensity score. A sedation intensity score was calculated for each study group each study protocol day, up to 30 days. Higher sedation intensity scores indicate more sedative exposure. If a subject did not receive any sedation, the sedative exposure score is zero for that respective day.

  Daily up to 30 days

• State Anxiety

  Participants reported their current level of anxiety each day enrolled in the study in response to the question "how are you feeling today"/ The Visual analog scale-anxiety was used to evaluate the self-report of anxiety. Scores range from 0 = not anxious at all to 100 = the most anxious ever. Higher numbers indicate greater anxiety. Daily anxiety scores from all subjects were combined and analyzed for each group resulting in an overall mean anxiety score at the end of the study protocol of 30 days.

  Daily up to 30 days

Secondary Outcomes (3)

• Length of ICU Stay

  From date of ICU admission to extubation or discharge or date of death from any cause, whichever came first assessed up to 60 days

• Length of Mechanical Ventilatory Support

  From initial intubation date to extubation or death, whichever came first, assessed up to 30 days.

• Urinary Cortisol

  Daily up to 30 days

Study Arms (3)

Patient-directed music

EXPERIMENTAL

Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.

Behavioral: Anxiety Self-Management, Patient preferred relaxing music

Headphones

ACTIVE COMPARATOR

Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.

Behavioral: Control 1: Noise-cancelling headphones

Standard of Care

OTHER

Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.

Behavioral: Control 2: Standard of Care

Interventions

Anxiety Self-Management, Patient preferred relaxing music BEHAVIORAL

Experimental group randomized to patient-directed music intervention where subjects listened to tailored, self-selected music as desired (frequency and length determined by the individual subject) each day they are receiving mechanical ventilatory support.

Also known as: self-initiated music listening

Patient-directed music

Control 1: Noise-cancelling headphones BEHAVIORAL

Control group: noise-canceling headphones only where subjects wear headphones as desired (frequency and length determined by the individual subject) each day they are receiving mechanical ventilatory support.

Also known as: noise-reduction headphones

Headphones

Control 2: Standard of Care BEHAVIORAL

Usual ICU nursing care.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient who is alert, on the ventilator because there is some condition involving the lungs preventing him/her from breathing on his/her own and willing and able to provide own consent.

You may not qualify if:

• On the ventilator because of a surgical procedure, not alert and unable to provide own consent.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (3)

• Heiderscheit A, Johnson K, Chlan LL. Analysis of Preferred Music of Mechanically Ventilated Intensive Care Unit Patients Enrolled in a Randomized Controlled Trial. J Integr Complement Med. 2022 Jun;28(6):517-529. doi: 10.1089/jicm.2021.0446. Epub 2022 Apr 4.

  PMID: 35377238 DERIVED

• Chlan LL, Heiderscheit A, Skaar DJ, Neidecker MV. Economic Evaluation of a Patient-Directed Music Intervention for ICU Patients Receiving Mechanical Ventilatory Support. Crit Care Med. 2018 Sep;46(9):1430-1435. doi: 10.1097/CCM.0000000000003199.

  PMID: 29727366 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Mental Disorders; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Overall limitations of the trial include the challenges of obtaining informed consent from patients' themselves. Many times patients were too sedated or not alert enough to participate in the consent process.

Results Point of Contact

• Title: Dr. Linda Chlan
• Organization: University of Minnesota

chlan001@umn.edu

612-624-6658

Study Officials

• Linda Chlan, PhD, RN

  University of Minnesota School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 27, 2007
• Study Start: July 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 26, 2013
• Results First Posted: April 26, 2013

Record last verified: 2013-04

Locations

US (1)