No registrations found.
ID
Source
Brief title
Health condition
Pectus excavatum
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main parameter is the experienced level of pain, assessed with self-report on the Visual Analogue Scale (VAS) expressed in millimetres.
Secondary outcome
• Morphine equivalence daily dose/kilogram (MEDD/kg) and total dosage of other analgesia:
• Score on State-Trait-Anxiety-Inventory questionnaire (STAI) and Health related quality of life (HRQoL):
• Physiologic measurements, including blood pressure, heart rate and respiratory rate:
• Complications, like post-operative ileus (n of days), nausea/vomiting (n of days and also anti-emetics used), pruritus:
• Length of hospital stay (n of days):
• Economic evaluation
Background summary
Rationale: This study will investigate the effects of listening to a recorded music intervention
prior, during and after surgical pectus excavatum treatment. Multiple studies have found
music interventions may reduce post-operative pain, anxiety and distress in patients
undergoing a surgical procedure. Since surgical pectus excavatum treatment is a highly
painful as well as distressing procedure, this durable non-toxic method could be a welcome
intervention. In this study, we will investigate the hypothesis that music interventions prior,
during and after pectus excavatum surgery will result in less postoperative pain and distress.
Objective: The main objective of this study is to investigate the role of recorded music prior,
during and after surgery as an additive treatment modality in reducing the level of pain.
Secondary objectives are effects of music on the use of analgesics, on anxiety and distress,
vital parameters, minor postoperative complications, quality of life and care-costs.
Study design: This study will be performed as a parallel randomised controlled intervention
trial.
Study population: The research will take place in patients in the age of 12 to 18 years old,
who are operated for the diagnosis pectus excavatum by the Nuss-procedure in the
participating centres.
Intervention: The intervention group will receive several music interventions, delivered by
headphone, prior and during surgery, as well as post-operatively. The control group will only
receive headphones during surgery but no music will be played.
Main study parameters/endpoints: The main study endpoint is self-reported pain-scores
defined on the Visual Analogue Scale (VAS). Other endpoints are the amount of morphine
used in the first three days postoperative as calculated by the Morphine Equivalent Dose
Daily/ kilogram (MEDD/kg), levels of anxiety and distress, Quality of Life and physiological
parameters such as heart rate, saturation and blood pressure.
Nature and extent of the burden and risks associated with participation, benefit and
group relatedness: The use of music as intervention has no known deleterious effects on
patients. Safety precautions will be taken to limit the volume of the music on headphones
during surgery. Patients in all study arms will receive standard perioperative care. Post-
operative care and pain control will be performed according to standard protocols in the
different centres of research. Burden includes the completion of several questionnaires.
Measurements of vital signs will be collected from normal care data. No extra site visits will
be necessary for participation in this study besides the regular check ups at the outpatient
clinic. This research is performed in minors from 12 years and older as well as adults, as this
operation is mainly done in the age of 12 to 16 years, however it is also performed in adults.
Study objective
Music interventions will reduce anxiety and pain in patients undergoing a nuss bar procedure due to pectus excavatum
Study design
At outpatient clinic, during hospitalization until the third day of hospitalization, 3 months postoperative at the outpatient clinic
Intervention
Music interventions pre-, intra- and postoperatively
Ryan Billar
Rutgersstraat 56
Rotterdam
The Netherlands
0031646794742
r.billar@erasmusmc.nl
Ryan Billar
Rutgersstraat 56
Rotterdam
The Netherlands
0031646794742
r.billar@erasmusmc.nl
Inclusion criteria
Age 12 – 18 years
Scheduled for primary PE repair according to the Nuss-procedure with either one or multiple bars
Postoperatively, initial placement of a thoracic epidural or both thoracic epidural and patient-controlled analgesia system
Good knowledge of the Dutch language, by both patients and parents
Written informed consent. Additional written informed consent by parents or legal guardian is only necessary for children under the age of 16 years.
Exclusion criteria
Hearing impairment
Secondary PE surgery or other prior thoracic surgery
Known severe mental or psychiatric disorder
Known impaired communication with patient and parents as collected
Presence of chronic pain syndrome: ongoing pain lasting longer than 3 months or ongoing pain lasting longer than the reasonably expected healing time for the involved tissues)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL6863 |
| NTR-old | NTR7041 |
| Other | METC EMC : 2016543 |