This is a Study to Evaluate if Music Therapy Can Reduce Stress and Increase Satisfaction of Patients Undergoing Ambulatory Surgery
Music Therapy to Reduce Perioperative Stress and Increase Satisfaction in Patients Undergoing Ambulatory Surgery: a Randomized Trial
1 other identifier
interventional
34
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
July 20, 2023
CompletedStudy Start
First participant enrolled
July 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2023
CompletedDecember 20, 2023
December 1, 2023
3 months
June 23, 2023
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
EXPERIMENTALThe 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.
CONTROL GROUP
NO INTERVENTIONThese patients will follow the standard surgical pathways as per daily routine.
Interventions
slower tempo music that can quiet mind and make patients feel soothed
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Davide La Regina, MD
Ente Ospedaliero Cantonale, Bellinzona
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