Anxiety, Critical Illness, Pain, Relaxation
Conditions
Brief summary
Noise in the ICU can worsen patient outcomes through factors such as increased cardiovascular stress, alteration in sleep, and increased discomfort or pain The purpose of this study is to determine the benefit of therapeutic music in the ICU on patients, their families, and ICU staff.
Detailed description
Noise in the ICU can worsen patient outcomes through factors such as increased cardiovascular stress, alteration in sleep, and increased discomfort or pain. The purpose of this study is to determine the benefit of therapeutic music in the ICU on patients, their families, and ICU staff. The results of this study will inform clinicians on best practices for redesigning, implementing and evaluating a patient and family focused therapeutic music program in the ICU.
Interventions
BEHAVIORALTherapeutic Music Session
The 20 minute therapeutic music session will consist of classical music performed by a pianist with or without flute accompaniment with an individual patient's ICU room.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: * Current hospitalization in adult ICU at Vanderbilt University Medical Center Patient
Exclusion criteria
* Airborne or special contact isolation * Unstable hypotension or bradycardia * Pregnancy * Current prisoner status * The inability to communicate either verbally or in writing in English to complete the therapeutic music evaluations * Refusal to participate Family Member Inclusion Criteria * Family member of ICU patient Family Member
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in perceived pain visual analog score | Immediately before and after therapeutic music session (about 20 minutes long) | Comparison of patient reported perceived pain visual analog score using an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). |
| Change in perceived anxiety visual analog score | Immediately before and after therapeutic music session (about 20 minutes long) | Comparison of patient reported perceived anxiety visual analog score using an 11-point numerical rating scale ranging from 0 (no anxiety) to 10 (worst possible anxiety). |
| Change in perceived relaxation visual analog scale | Immediately before and after therapeutic music session (about 20 minutes long) | Comparison of patient reported perceived relaxation visual analog score using an 11-point numerical rating scale ranging from 0 (not relaxed at all) to 10 (completely relaxed). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Appropriateness Measure (IAM) | After conclusion of therapeutic music session (about 20 minutes) | Assessment of appropriateness of therapeutic music session using the IAM which is a 4-item survey where each item is scored on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Higher total AIM scores indicate greater implementability. This assessment will be completed by ICU clinical staff. |
| Acceptability of Intervention Measure (AIM) | After conclusion of therapeutic music session (about 20 minutes) | Assessment of acceptability of therapeutic music session using the AIM which is a 4-item survey where each item is scored on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Higher total AIM scores indicate greater implementability. This assessment will be completed by patients, family members, and ICU clinical staff. |
| Perceived Barriers | After conclusion of therapeutic music session (about 20 minutes) | Perceived barriers will be assessed using qualitative analysis of a 2-item multiple response option and open-ended questions asking for feedback about facilitation and barriers to implementation of therapeutic music in ICU. |
| Patient Perceived Impact | After conclusion of therapeutic music session (about 20 minutes) | Patient and family member perceived impact will be assessed using the Patient Music Evaluation Form. Patient and family member participants will complete this 2-item word choice question form to assess how live music made them feel (26 word choices offered eg., happy, sad, hopeful, energized) and whether the music performance made them do anything (20 word choices offered eg., laugh, smile, sing). |
| Feasibility of Intervention (FIM) | After conclusion of therapeutic music session (about 20 minutes) | ICU clinical staff perceived feasibility of therapeutic music session intervention will be assessed with the FIM, a 4-item, 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Higher total scores indicate greater feasibility. |
Countries
United States
Outcome results
None listed