This is a Study to Evaluate if Music Therapy Can Reduce Stress and Increase Satisfaction of Patients Undergoing Ambulatory Surgery

December 19, 2023 updated by: Ente Ospedaliero Cantonale, Bellinzona

Music Therapy to Reduce Perioperative Stress and Increase Satisfaction in Patients Undergoing Ambulatory Surgery: a Randomized Trial

Patients who undergo outpatient surgery according to normal practice will be divided into two groups.

The first group (17 patients), before and after their surgery, will listen to relaxing music, namely a slower tempo music that can quiet mind and make patients feel soothed.

The second group (17 patients) will follow the standard surgical pathways according to normal clinical practice, in particular they will not listen to relaxing music.

A questionnaire to evaluate stress and satisfaction will be administered to all the patients before their discharge

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bellinzona, Switzerland
        • Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing outpatient surgery
  • Age ≥ 18 years
  • Signed informed consent

Exclusion Criteria:

  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MUSIC AND COMFORT THERAPY
The intervention group will be "exposed" pre- and postoperatively to relaxing music, which is defined as a slower tempo music that can quiet mind and make patients feel soothed.
Other: Music Therapy
slower tempo music that can quiet mind and make patients feel soothed
No Intervention: CONTROL GROUP
These patients will follow the standard surgical pathways as per daily routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concern
Time Frame: during hospitalization, 1 day
Concern (measured on the validated Leiden Perioperative Patient Satisfaction -LPPS - questionnaire for the perioperative patients' satisfaction). This questionnaire assess patient satisfaction with perioperative care. Patients are asked to score each question on a fivepoint scale (from 1 - corresponding to the worse outcome to 5 - the best outcome)
during hospitalization, 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personal satisfaction
Time Frame: during hospitalization, 1 day
In hospital satisfaction (measured on the validated Leiden Perioperative Patient Satisfaction -LPPS - questionnaire for the perioperative patients' satisfaction. This questionnaire assess patient satisfaction with perioperative care. Patients are asked to score each question on a fivepoint scale (from 1 - corresponding to the worse outcome to 5 - the best outcome)
during hospitalization, 1 day
Length of hospital stay
Time Frame: during hospitalization, 1 day
number of hours the participant is being hospitalized
during hospitalization, 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Investigators

  • Principal Investigator: Davide La Regina, MD, Ente Ospedaliero Cantonale, Bellinzona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2023

Primary Completion (Actual)

October 23, 2023

Study Completion (Actual)

October 23, 2023

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ORBV-CHIR-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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