NCT05953870

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2023

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

June 23, 2023

Last Update Submit

December 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Concern

    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 Outcomes (2)

  • Personal satisfaction

    during hospitalization, 1 day

  • Length of hospital stay

    during hospitalization, 1 day

Study Arms (2)

MUSIC AND COMFORT THERAPY

EXPERIMENTAL

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

CONTROL GROUP

NO INTERVENTION

These patients will follow the standard surgical pathways as per daily routine.

Interventions

slower tempo music that can quiet mind and make patients feel soothed

MUSIC AND COMFORT THERAPY

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale

Bellinzona, Switzerland

Location

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Davide La Regina, MD

    Ente Ospedaliero Cantonale, Bellinzona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 20, 2023

Study Start

July 20, 2023

Primary Completion

October 23, 2023

Study Completion

October 23, 2023

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations