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Completed

NCT Number: NCT05374096

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

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

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Key information

Conditions

Postoperative Pain, Acute Anxiety Anxiety Disorders Hernia Hernia Abdominal Wall Hernia, Abdominal Hernia, Ventral Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgery Ventral Hernia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults having open retromuscular ventral hernia repair with mesh, with or without myofascial release for a hernia width ≤ 20 cm
  • Adults having open flank hernia repair that requires a myofascial release with mesh
  • Adults having parastomal hernia repair with mesh

Exclusion criteria

  • Primary language other than English, or lack of English language fluency
  • Hearing impairment, with or without use of hearing aids
  • Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and anxiety
  • Patients who will remain intubated after surgery

Treatment and study plan

Patient-Chosen Music

Other

Music played into headphones.

Placebo

Other

Silence into headphones.

Primary outcomes

  1. Post operative Pain

    Time frame: 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 outcomes

  1. Post operative Anxiety

    Time frame: 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 outcomes

  1. Post operative Pain - 3 days

    Time frame: 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")

  2. Post operative Pain - cumulative

    Time frame: 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")

  3. Post operative Anxiety - 3 days

    Time frame: 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.

  4. Post operative opioid consumption

    Time frame: During the first 72 hours after surgery end time.

    Cumulative opioid consumption converted into morphine milligram equivalents.

  5. Intraoperative sedative use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 16, 2022
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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