No registrations found.
ID
Source
Brief title
Health condition
Esophageal cancer, Esophagectomy, gastric cancer, gastrectomy, music, perioperative patient care, stress response to surgery.
Slokdarmkanker, slokdarmresectie, maagkanker, maagresectie, muziek, perioperatieve patientenzorg, chirurgische stress respons
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is postoperative pain (Numeric Rating Scale (NRS)).
Secondary outcome
Secondary outcomes are intraoperative medication requirement (intraoperative propofol, opioids and catecholamines), postoperative opioid requirement, stress response to surgery (serum cortisol, tumor necrosis factor alpha (TNF-α), interleukin-6 (IL-6), C-reactive protein (CRP)), intraoperative vital parameters, postoperative complications, hospital length of stay and 30-day mortality.
Background summary
Perioperative music has a significant beneficial effect on postoperative pain and anxiety, possibly through attenuation of the stress response to surgery. This beneficial effect can still be observed when music is played solely during general anaesthesia, since auditory sensory information is processed by the brain even under deep sedation. High pain levels and a more vigorous stress response after surgery have a negative impact on patient outcome. This study will investigate the effect of intraoperative music in patients undergoing surgery for esophageal or stomach cancer under general anaesthesia.
The main objective of this study is to investigate whether intraoperative music reduces postoperative pain in patients undergoing surgery for esophageal or stomach cancer. Secondary objectives are the effects of intraoperative music on medication requirement, stress response to surgery, intraoperative vital parameters, postoperative complications, hospital length of stay and 30-day mortality.
Study objective
Perioperative music has a significant beneficial effect on postoperative pain, which can even be observed when music is played solely during general anaesthesia since auditory sensory information is processed by the brain under deep sedation. Perioperative music also attenuates the physiological stress response to surgery.
The study hypothesis is that the beneficial effect of music on postoperative pain and the stress response to surgery will improve patient clinical outcome by reducing postoperative complications and hospital length of stay.
Study design
Surgery and intraoperative music intervention
30-day follow-up (electronic patient database)
Intervention
Patients will be randomly allocated to one of two study arms. 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 literature.
V.X. Fu
P.O. Box 2040
Rotterdam 3000 CA
The Netherlands
v.fu@erasmusmc.nl
V.X. Fu
P.O. Box 2040
Rotterdam 3000 CA
The Netherlands
v.fu@erasmusmc.nl
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Patients undergoing elective surgical esophageal or stomach cancer resection
2. Age ≥ 18 years
3. Provision of written informed consent by the patient
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7330 |
| NTR-old | NTR7546 |
| CCMO | NL64875.078.18 |
| OMON | NL-OMON48702 |