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Completed

NCT Number: NCT03171753

Preoperative Anxiety and Music Therapy

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.

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Key information

Conditions

Anxiety State Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedali Riuniti

Foggia, FG, 70100, Italy

About this study

Patients undergoing elective surgical intervention will be allocated in two groups: Group M will listen prerecorded music through an individual headset for 30 min before the induction of anesthesia; Group C will listen no sound through an individual headset for 30 min before the induction of anesthesia The degree of stress and anxiety the patients will be assessed using questionnaire. Laboratory enzymes will be measured.

Heart rate, non invasive arterial pressure, pulse oximetry,skin resistance will be recorded. All the patients will receive continuous ECG holter recording .

To assess the effect of music therapy on the degree of autonomic modulation, HRV will be analyzed with traditional time and frequency measures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Questionnaire

Diagnostic Test

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

Laboratory test

Diagnostic 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

cardiac monitoring

Diagnostic Test

the cardiac monitoring will be performed through study period

skin resistance

Diagnostic Test

the skin resistance monitoring will be performed through study period

Music listening

Device

Listening prerecorded music through an individual headset for 30 min

No sound

Device

No sound through an individual headset for 30 min

Primary outcomes

  1. cardiac monitoring

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

    cardiac variability

Secondary outcomes

  1. questionnaire

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

    anxiety questionnarie

  2. laboratory test

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

    enzyme dosage

Sponsors and collaborators

Lead sponsor

University of Foggia

Other

Registry information

Official study title

Anxiety, Preoperative Stress and Music Therapy

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 31, 2017
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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