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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05953870
Recruitment Status : Completed
First Posted : July 20, 2023
Last Update Posted : December 20, 2023
Sponsor:
Information provided by (Responsible Party):
Ente Ospedaliero Cantonale, Bellinzona

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Stress Personal Satisfaction Other: Music Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Music Therapy to Reduce Perioperative Stress and Increase Satisfaction in Patients Undergoing Ambulatory Surgery: a Randomized Trial
Actual Study Start Date : July 20, 2023
Actual Primary Completion Date : October 23, 2023
Actual Study Completion Date : October 23, 2023
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. Length of hospital stay [ Time Frame: during hospitalization, 1 day ]
    number of hours the participant is being hospitalized


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or lactating women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05953870


Locations
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Switzerland
Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale
Bellinzona, Switzerland
Sponsors and Collaborators
Ente Ospedaliero Cantonale, Bellinzona
Investigators
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Principal Investigator: Davide La Regina, MD Ente Ospedaliero Cantonale, Bellinzona
More Information
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Responsible Party: Ente Ospedaliero Cantonale, Bellinzona
ClinicalTrials.gov Identifier: NCT05953870    
Other Study ID Numbers: ORBV-CHIR-003
First Posted: July 20, 2023    Key Record Dates
Last Update Posted: December 20, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No