The primary objective is to see whether a live music intervention can significantly lower perceived postoperative pain compared to recorded music intervention and do-nothing control. The secondary objective is to explore neuroinflammatory…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
perceived postoperative pain
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference between subjective pain ratings
before and after music intervention and after 3- and 6-hour follow-up.
Secondary outcome
• objective pain metric (volume of administered pain medication)
• respiratory rate and tidal volume
• Heart rate (HR)
• Blood pressure
• neuroinflammation blood markers (IL6, NGAL, CRP, serum TPSO);
• behavioral indicators of neuroinflammation (delirium and post-operative
cognitive decline incidence);
• EEG markers of neuroinflammation (alpha-power, delta/alpha power ratio,
entropy).
Background summary
Postoperative patients who previously engaged in the live musical intervention
Meaningful Music in Healthcare (MiMiC) reported significantly reduced
perception of pain than patients without the intervention (van der Wal- Huisman
et al., 2020). This encouraging finding indicates a potential for postsurgical
musical interventions to have a place in standard care as therapeutic pain
relief. However, live music is logistically complex in hospital settings, and
previous studies have reported the more cost-effective recorded music to serve
a similar pain-reducing function in post-surgical patients (van der Wal-
Huisman et al., 2018). Moreover, little is known about the potential underlying
physiological mechanisms that may be responsible for the reduced pain perceived
by patients after live music intervention.
Study objective
The primary objective is to see whether a live music intervention can
significantly lower perceived postoperative pain compared to recorded music
intervention and do-nothing control. The secondary objective is to explore
neuroinflammatory underpinnings of postoperative pain, and the potential role
of music intervention in mitigating neuroinflammation.
Study design
This intervention study will compare subjective postsurgical pain ratings among
three groups: live music intervention, recorded music intervention, and
standard care control. The design will take the form of an on-off
non-randomized controlled trial (NCT, Mathe et al., 2015).
Intervention
Intervention is a daily music session of up to 30 minutes for a maximum of five
days. The live music intervention group is visited by professional musicians
once a day for 15 minutes and asked to interact. The recorded music, active
control intervention group receives 15 minutes of pre-selected music over
headphones. The do-nothing group receives typical post-surgical care that does
not include music.
Study burden and risks
Participants will be in recovery after elective surgery in the UMCG.
Participation requires approximately 12 minutes questionnaires before surgery.
Daily data collection includes one blood sample (10ml), one hour total of EEG
recording, four times daily HR, blood pressure, respiration rate, pain rating
on a VAS, and (unless standard-care treatment) ~15 minutes of live or recorded
music intervention. As blood samples and measurements of HR, blood pressure and
respiration rate are routine measurements collected as part of standard
postoperative care, they will be integrated with standard care insofar as
possible. There are no known risks for participation. Based on past related
research (UMCG research register 201600541), patients generally seem to enjoy
the music interventions.
Hanzeplein 1 1
Groningen 9700 RB
NL
Hanzeplein 1 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
over 18 years
elective surgery
post-surgery hospitalization
able to hear music
able to give informed consent
able to communicate
Exclusion criteria
under 18
outpatient surgery
acute surgery
severe hearing loss/unable to hear music
unable to communicate
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL76900.042.21 |