Skip to content

Intraoperative Music to PROMote PaTient oUtcome (IMPROMPTU): a double-blind, placebo-controlled, randomized multicenter trial

Intraoperative Music to PROMote PaTient oUtcome (IMPROMPTU): a double-blind, placebo-controlled, randomized multicenter trial - IMPROMPTU

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48702
Enrollment
70
Registered
2018-07-19
Start date
2018-11-20
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal and gastric cancer surgery gullet and stomach cancer surgery

Interventions

The intervention group will receive intraoperative music as an intervention
the control group will not hear music. All participants will wear headphones during surgery. The music intervention will consist of a preselected playlist of music based on recommendations of litera

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective esophageal or stomach cancer surgery 2. Age * 18 years 3. Provision of written informed consent by the patient

Exclusion criteria

Exclusion criteria: 1. Patients using systemic steroid, immunosuppressant or cytotoxic medication at the moment of music intervention 2. Known hearing impairment or use of an hearing aid 3. Insufficient knowledge of the Dutch language to understand the study documents in the judgement of the attending physician or researcher 4. Objection to any unknown music 5. Patients with locally advanced, unresectable esophageal or stomach cancer

Design outcomes

Primary

MeasureTime frame
Postoperative pain (NRS)

Secondary

MeasureTime frame
- Intraoperative medication requirement - Postoperative opioid requirement - Stress response to surgery (serum total cortisol, tumor necrosis factor alpha (TNF-*), interleukin-6 (IL-6) and C-reactive protein (CRP)) - Postoperative complications - Hospital length of stay - 30-day mortality

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)