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NCT Number: NCT06174662

The Effect of Music on Procedural Distress During Mobilization in Intensive Care Unit Patients: A Randomized Controlled Trial

This intervention study will investigate the effects of music therapy on procedural distress, the overall experience of pain, anxiety, and stress, during the procedure of sitting up in a chair for patients admitted to the intensive care unit (ICU).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Antwerp

Wilrijk, Antwerp, 2610, Belgium

Location status: Recruiting

Location contact

Filip Haegdorens, PhD

CONTACT

[email protected]

0032497769040

About this study

There is a paucity of literature on the use of music therapy ('music care') in intensive care units (ICUs) during the process of mobilization. However, research suggests that mobilization can reduce the risk of depression and improve cognitive function (Chiang et al., 2006). This study aims to investigate the impact of music therapy on procedural comfort during sit-to-stand mobilization in ICU patients.

Specifically, the investigators seek to examine the effects of music therapy on pain perception, stress levels, anxiety levels, and vital parameters (blood pressure, heart rate, and respiratory rate) during this procedure. The investigators hypothesize that music therapy can improve procedural comfort by reducing pain, stress, and anxiety.

This study employs quantitative multicenter research, specifically a randomized controlled trial (RCT), involving ICU patients at three hospitals: AZ Monica Deurne, GZA campus Sint-Augustinus, and Sint-Vincentius.

During the intervention, patients will listen to their preferred music through noise-canceling headphones. Patients will be able to select their preferred music.

To assess the effects of music therapy, the investigators developed a self-designed measurement tool, validated using content validation indices (CVI) with an expert panel including pain nurses. The tool measures various indicators, including:

Vital parameters: (arterial) blood pressure, heart rate, and respiratory rate

Pain perception: Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's pain level. Zero indicates no pain, while 10 represents the worst imaginable pain.

Anxiety and stress levels: Nurses will utilize 11-point Likert scales from 0 to 10 to measure the patient's anxiety and stress levels. The sum of these three scores will provide an overall measure of procedural distress.

To assess the duration of the effects of music therapy, we will record the above indicators at four time points:

Time 0: Ten minutes before sit-to-stand mobilization begins

Time 1: Ten minutes after sit-to-stand mobilization is completed

Time 2: Immediately before returning the patient to bed, after music stops

Time 3: Ten minutes after the patient is back in bed

Delta calculations will be performed to measure changes between time points.

The selected music playlist will be briefly noted on the measurement tool, and a final Likert scale will assess patient satisfaction with the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • They are admitted to the ICU
  • They have a Richmond Agitation-Sedation Scale (RASS) score of +1, 0, or -1
  • They are able to speak Dutch

Exclusion criteria

  • They are younger than 18 years old
  • They have a hearing impairment
  • They are in isolation
  • They have a cranial dressing or intracranial pressure monitoring

Treatment and study plan

Music

Device

The patient can decide the music genre (a standard playlist) and receives a noise-cancelling headphone playing the chosen music during mobilization.

Primary outcomes

  1. pain perception level

    Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed

    Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's pain level

  2. stress perception level

    Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed

    Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's stress level.

  3. anxiety perception level

    Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed

    Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's anxiety level.

Secondary outcomes

  1. Time of mobilization

    Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed

    Time in minutes of mobilization

  2. Blood pressure

    Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed

    Systolic Blood Pressure

  3. Heart rate

    Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed

    Heart frequency per minute

  4. Respiratory frequency

    Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed

    Respiratory frequency per minute

Study contacts

Contact information is provided by the study sponsor or research team.

Filip Haegdorens, PhD

CONTACT

[email protected]

003232659169

Lotte Heirbaut, RN

CONTACT

[email protected]

003232659169

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Registry information

Acronym: MUSICU

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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