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…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative pain (NRS)
Secondary outcome
- 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
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.
Study objective
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
intraoperative medication requirement, postoperative opioid requirement, stress
response to surgery, intraoperative vital parameters, postoperative
complications, hospital length of stay and 30-day mortality.
Study design
Double-blind, placebo-controlled, randomized multicenter trial
Intervention
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 and experts.
Study burden and risks
Music has no known deleterious effects. A lock on the music volume will be
installed to limit the music volume. Part of the measurements and data
collection is embedded in standard surgical care, and part will be collected
for study purposes, consisting of two blood samples and one 4-item
questionnaire. No additional hospital visits are necessary for this study. This
study will be performed in patients with esophageal or stomach cancer, in which
surgical treatment is associated with high morbidity and mortality, and
reducing postoperative pain and the stress response to surgery may lead to a
decrease in postoperative complications and hospital length of stay. Overall,
the burden and risks associated with the intervention in this study are
negligible.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
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
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
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64875.078.18 |
| OMON | NL-OMON23998 |