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

Sponsor

Ente Ospedaliero Cantonale, Bellinzona (Other)

Overall Status

Recruiting

CT.gov ID

NCT05953870

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jul 31, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

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.

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

Primary Outcome Measures

Concern [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

Personal satisfaction [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)
Length of hospital stay [during hospitalization, 1 day]
number of hours the participant is being hospitalized

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing outpatient surgery
Age ≥ 18 years
Signed informed consent

Exclusion Criteria:

Pregnant or lactating women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale	Bellinzona		Switzerland

Sponsors and Collaborators

Ente Ospedaliero Cantonale, Bellinzona

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ente Ospedaliero Cantonale, Bellinzona

ClinicalTrials.gov Identifier:

NCT05953870

Other Study ID Numbers:

ORBV-CHIR-003

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 24, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 24, 2023