Anxiety, Hernia Abdominal Wall, Postoperative Pain, Acute, Surgery, Ventral Hernia
Conditions
Keywords
Music
Brief summary
The purpose of this study is to assess whether listening to music during surgery has an effect on pain or anxiety after surgery.
Detailed description
After being informed about the study and potential risks and meeting eligibility criteria, all patients giving written informed consent will be scheduled for their hernia repair surgery. On the day of surgery, patients will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to listen to patient-chosen music during their surgery via headphones or just listen to silence via headphones. Pain and anxiety will then be assessed after surgery.
Interventions
OTHERPatient-Chosen Music
Music played into headphones.
OTHERPlacebo
Silence into headphones.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults having open retromuscular ventral hernia repair with mesh, with or without myofascial release for a hernia width ≤ 20 cm 2. Adults having open flank hernia repair that requires a myofascial release with mesh 3. Adults having parastomal hernia repair with mesh
Exclusion criteria
1. Primary language other than English, or lack of English language fluency 2. Hearing impairment, with or without use of hearing aids 3. Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and anxiety 4. Patients who will remain intubated after surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative Pain | At 24 hours (+- 3 hours) after surgery end time. | Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post operative Anxiety | At 24 hours (+- 3 hours) after surgery end time. | Anxiety scores will be assessed using State Trait Anxiety Index-6 (STAI-6) Anxiety tool (a 6 question patient-reported anxiety assessment). The higher the total, the greater the anxiety is. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post operative Anxiety - 3 days | Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours) | Anxiety scores will be assessed using State Trait Anxiety Index-6 (STAI-6) Anxiety tool (a 6 question patient-reported anxiety assessment). The higher the total, the greater the anxiety is. |
| Post operative opioid consumption | During the first 72 hours after surgery end time. | Cumulative opioid consumption converted into morphine milligram equivalents. |
| Intraoperative sedative use | From induction of anesthesia to arrival in the post anesthesia care unit on the day of procedure | Total number of intravenous and inhaled anesthetics, benzodiazepines, and opioid medications. |
| Post operative Pain - cumulative | Will be collected repeatedly by nursing staff per nursing protocol for the first 24 hours after surgery end time. | Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) |
| Post operative Pain - 3 days | Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours) | Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) |
Countries
United States
Outcome results
None listed