Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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A three group randomized trial with repeated measures. Participants are assigned by chance to one of three groups: 1) patient-directed, as desired music listening through headphones, 2) noise-canceling headphones only, or 3) usual care. Participants remain in the study, up to 30 days, as long as they are receiving mechanical ventilation in the ICU, choose to withdraw, or become unable to complete the daily anxiety assessments. Information is collected daily on patient-perceived anxiety levels (visual analog scale \& State Anxiety Inventory), ventilator settings, and all medications received. Urine is collected each day the participant is on the ventilator to determine level of stress (cortisol) if the kidneys are functioning appropriately and the participant is not receiving medications known to influence cortisol levels.

Mechanical ventilation is a common treatment for respiratory problems for patients in the ICU. Patients receiving mechanical ventilation experience much anxiety and distress from the placement of the endotracheal tube (breathing tube) and the mechanical ventilator itself. The usual treatment for these symptoms are medications, which are very potent and have numerous adverse side effects, removing patient involvement and control from managing these symptoms. Music has been shown to decrease anxiety and promote relaxation in limited, single listening intervention studies with patients in the ICU on ventilators. This study tests whether having patients listen to preferred music (familiar \& comforting) whenever feeling anxious and wanting to relax for as long as they would like to listen to music through headphones throughout the entire time they are on the ventilator can improve outcomes such as less anxiety, shorter time on the ventilator, receipt of fewer medications, and less stress when compared to patients who do not listen to music while they are on the ventilator. Results from this study will advance nursing science by providing evidence on the efficacy of a simple, self-directed intervention that the millions of patients who receive mechanical ventilation each year in the ICU can use themselves to treat the very common symptoms of anxiety and distress. Results from this study will expand the knowledge base of adjunctive interventions that can be implemented in the ICU to involve patients directly in managing their own symptoms, ultimately improving patient outcomes.

Patients who are alert and can provide consent are invited to participate if they are on the ventilator in one of the participating ICUs. Patients remain in the study for as long as they are on the ventilator (up to 30 days) and can provide daily assessment of their anxiety levels. Patients are free to withdraw, however, at any time. Patients randomized to music receive an assessment of their music preferences by a professional music therapist. The music therapist then develops a music collection for each participant, based in individual preferences, that is kept at the bedside throughout the duration of being on the ventilator. The music therapist also visits with music participants' daily to determine if preferences have changed and if he/she desires additional music compact disks (CDs) to be kept at the bedside. Data is collected from the medical record on all medications and ventilator settings each day the participant is enrolled in the study. All urine is collected each day the participant remains in the study if the kidneys are functioning properly and the participant is not receiving medications known to influence cortisol, a marker for an integrative level of stress.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient-directed music

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.

Group Type EXPERIMENTAL

Anxiety Self-Management, Patient preferred relaxing music

Intervention Type 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.

Headphones

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

Group Type ACTIVE_COMPARATOR

Control 1: Noise-cancelling headphones

Intervention Type 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.

Standard of Care

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

Group Type OTHER

Control 2: Standard of Care

Intervention Type BEHAVIORAL

Usual ICU nursing care.

Interventions

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Anxiety Self-Management, Patient preferred relaxing music

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.

Intervention Type BEHAVIORAL

Control 1: Noise-cancelling headphones

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.

Intervention Type BEHAVIORAL

Control 2: Standard of Care

Usual ICU nursing care.

Intervention Type BEHAVIORAL

Other Intervention Names

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self-initiated music listening noise-reduction headphones

Eligibility Criteria

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Inclusion Criteria

* 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.