NCT05374096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 16, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

June 13, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

May 2, 2022

Last Update Submit

July 20, 2023

Conditions

Postoperative Pain, AcuteVentral HerniaHernia Abdominal WallSurgeryAnxiety

Keywords

Music

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Post operative Anxiety

    At 24 hours (+- 3 hours) after surgery end time.

Other Outcomes (5)

  • 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)

  • Post operative Pain - cumulative

    Will be collected repeatedly by nursing staff per nursing protocol for the first 24 hours after surgery end time.

  • 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)

  • +2 more other outcomes

Study Arms (2)

Music Via Headphones

EXPERIMENTAL

Headphones will be placed with patient-selected music playing for the duration of the surgical procedure.

Other: Patient-Chosen Music

Silence Via Headphones (Control)

PLACEBO COMPARATOR

Headphones will be placed with silence for the duration of the surgical procedure.

Other: Placebo

Interventions

Patient-Chosen MusicOTHER

Music played into headphones.

Music Via Headphones
PlaceboOTHER

Silence into headphones.

Silence Via Headphones (Control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • Maskal SM, Gentle CK, Ellis RC, Tu C, Rosen MJ, Petro CC, Miller BT, Beffa LRA, Chang JH, Messer N, Melland-Smith M, Jeekel J, Prabhu AS. Does selective intraoperative music reduce pain following abdominal wall reconstruction? A double-blind randomized controlled trial. Hernia. 2024 Oct;28(5):1831-1841. doi: 10.1007/s10029-024-03092-y. Epub 2024 Jun 18.

    PMID: 38890182DERIVED

MeSH Terms

Conditions

Pain, PostoperativeHernia, VentralHernia, AbdominalAnxiety Disorders

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsHerniaPathological Conditions, AnatomicalMental Disorders

Study Officials

  • Ajita Prabhu, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 16, 2022

Study Start

June 13, 2022

Primary Completion

July 15, 2023

Study Completion

July 17, 2023

Last Updated

July 21, 2023

Record last verified: 2023-07

Locations

US(1)