A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress, Mood, Pain and Biomarkers, in Neurosurgical Patients (Music-STAR Trial)

ConditionsStressPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

The study plans to enroll a total of 132 patients. The goal of this study is to measure pre-and post-music intervention changes in patients' vital signs, serum- and plasma-level biomarkers by broad-spectrum proteomics analysis, metabolic analysis, and perceived pain, anxiety, and mood states as measured by validated questionnaires (STAI-S, POMS-SF, and VASP). We will collect demographic information on each participant. Participants will also complete the Brief Musical Experience Questionnaire (BMEQ) to investigate potential links between susceptibility to music-induced anxiolysis and prior musical training, preference and exposure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patient is unable or unwilling to provide informed consent.

Patient is deaf or hearing-disabled.

Patient is less than 18 years in age.

Patient was previously enrolled in the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Steinway Spirio M recording/player piano

    Other intervention

    Patients will be equally randomized into one of the three arms (simulated live music, recorded music, or no music) applying the random permutated block. Randomization will be conducted via an approved institutional database with the randomization list generated by the study statistician.

Treatment groups

132 Participants
are divided into 3 treatment groups
Group A: Patients: Simulated Live MusicExperimental treatment 1 intervention
Group B: Patients: Recorded MusicExperimental treatment 1 intervention
Group C: Patients: Control: No MusicExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Stress and mood changes

Pre-post intervention changes in physiologic and perceived stress and mood changes by BP, STAI-S, VASP and POM-S.

Time frame
Through study cmpletion
2

Stress biomarkers

Proteomic and metabolomic analyses, in stress biomarkers and cytokines including IL-6, cortisol and epinephrine.

Time frame
Through study completion

Secondary outcomes

1

BMEQ (Brief Music Experience Questionnaire)

Approximately 15 minutes to complete each time)

Time frame
Through study completion

Other outcomes

Sponsors and contacts

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