Study Exploring the Effect of Music on Pain After Ventral Hernia Surgery

Anxiety Clinical Trial

Official title:

The Effect of Music on Pain in Patients Undergoing Ventral Hernia Repair With Mesh: A Double-Blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05374096
• Other study ID #: 22-286
• Status: Completed
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: July 17, 2023

Study information

• Verified date: July 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether listening to music during surgery has an effect on pain or anxiety after surgery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: July 17, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anxiety
• Hernia
• Hernia Abdominal Wall
• Hernia, Ventral
• Pain, Postoperative
• Surgery
• Ventral Hernia

Intervention

Other:
• Patient-Chosen Music
Music played into headphones.
• Placebo
Silence into headphones.

Locations

Country	Name	City	State
United States	Cleveland Clinic Main Campus	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post operative Pain - 3 days	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")	Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours)
Other	Post operative Pain - cumulative	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")	Will be collected repeatedly by nursing staff per nursing protocol for the first 24 hours after surgery end time.
Other	Post operative Anxiety - 3 days	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.	Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours)
Other	Post operative opioid consumption	Cumulative opioid consumption converted into morphine milligram equivalents.	During the first 72 hours after surgery end time.
Other	Intraoperative sedative use	Total number of intravenous and inhaled anesthetics, benzodiazepines, and opioid medications.	From induction of anesthesia to arrival in the post anesthesia care unit on the day of procedure
Primary	Post operative Pain	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")	At 24 hours (+- 3 hours) after surgery end time.
Secondary	Post operative Anxiety	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.	At 24 hours (+- 3 hours) after surgery end time.