NCT03171753

Brief Summary

Music can reduce anxiety in adult patients awaiting surgical interventions. The study was designed to test the difference in cardiac parameters, anxiety questionnaire, laboratory enzymes, skin resitance between surgical patients listening music vs no sound.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

1.4 years

First QC Date

May 24, 2017

Last Update Submit

September 15, 2017

Conditions

Anxiety State

Outcome Measures

Primary Outcomes (1)

  • cardiac monitoring

    cardiac variability

    through study period (to 15 min before the application of headphones until 15 minutes after their removal

Secondary Outcomes (2)

  • questionnaire

    questionnaire score change 15 min after the removal of headphones from baseline ( early before the application of headphones)

  • laboratory test

    enzyme level change early after the application of headphones from baseline (early before the application of headphones)

Study Arms (2)

Music therapy

EXPERIMENTAL

Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia

Diagnostic Test: questionnaireDiagnostic Test: laboratory testDiagnostic Test: cardiac monitoringDiagnostic Test: skin resistanceDevice: Music listening

Control

ACTIVE COMPARATOR

patients wear headphones for 30 minuts without any sound

Diagnostic Test: questionnaireDiagnostic Test: laboratory testDiagnostic Test: cardiac monitoringDiagnostic Test: skin resistanceDevice: No sound

Interventions

questionnaireDIAGNOSTIC_TEST

questionnarie will be performed before the application of headphone and after their removal.

ControlMusic therapy
laboratory testDIAGNOSTIC_TEST

laboratory test will be collected before the application of headphone and after their removal. the cardiac monitoring will be performed during the all study period

ControlMusic therapy
cardiac monitoringDIAGNOSTIC_TEST

the cardiac monitoring will be performed through study period

ControlMusic therapy
skin resistanceDIAGNOSTIC_TEST

the skin resistance monitoring will be performed through study period

ControlMusic therapy
Music listeningDEVICE

Listening prerecorded music through an individual headset for 30 min

Music therapy
No soundDEVICE

No sound through an individual headset for 30 min

Control

Eligibility Criteria

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

You may qualify if:

  • Elective surgical patients \>18 years old, after obtaining informed consent

You may not qualify if:

  • patients with hearing impairment,
  • any known psychiatric or memory disorder
  • thyroid disease.
  • atrial fibrillation
  • pace-maker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedali Riuniti

Foggia, FG, 70100, Italy

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Pain MeasurementClinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Neurologic ExaminationPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Aggregate Professor, PhD

Study Record Dates

First Submitted

May 24, 2017

First Posted

May 31, 2017

Study Start

February 15, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

September 18, 2017

Record last verified: 2017-09

Locations

IT(1)