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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversiteit Antwerpen

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Music

    Device

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

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: MusicExperimental treatment 1 intervention
Group B: No musicNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

pain perception level

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

Time frame
Ten minutes before mobilization begins and ten minutes after mobilization is completed
2

stress perception level

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

Time frame
Ten minutes before mobilization begins and ten minutes after mobilization is completed
3

anxiety perception level

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

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

Secondary outcomes

1

Time of mobilization

Time in minutes of mobilization

Time frame
Ten minutes before mobilization begins and ten minutes after mobilization is completed
2

Blood pressure

Systolic Blood Pressure

Time frame
Ten minutes before mobilization begins and ten minutes after mobilization is completed
3

Heart rate

Heart frequency per minute

Time frame
Ten minutes before mobilization begins and ten minutes after mobilization is completed
4

Respiratory frequency

Respiratory frequency per minute

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

Other outcomes

Sponsors and contacts

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