Anxiety StateNCT03171753
Preoperative Anxiety and Music Therapy
A study testing questionnaire, laboratory test and cardiac monitoring in people with Anxiety State, run by University of Foggia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety State
- What is being tested?
- questionnaire, laboratory test and cardiac monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgical patients >18 years old, after obtaining informed consent
Who cannot join
- patients with hearing impairment,
- any known psychiatric or memory disorder
- thyroid disease.
- atrial fibrillation
- pace-maker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anxiety, Preoperative Stress 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.
Read the detailed description
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.
- Conditions
- Anxiety State
- Being tested
- questionnaire, laboratory test, cardiac monitoring, skin resistance, Music listening
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireDiagnostic test
questionnarie will be performed before the application of headphone and after their removal.
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
cardiac monitoringDiagnostic test
the cardiac monitoring will be performed through study period
skin resistanceDiagnostic test
the skin resistance monitoring will be performed through study period
Music listeningDevice
Listening prerecorded music through an individual headset for 30 min
No soundDevice
No sound through an individual headset for 30 min
| Study group | Role | What they receive |
|---|---|---|
| Music therapy | Experimental | Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia Receives: Diagnostic Test: questionnaire; Diagnostic Test: laboratory test; Diagnostic Test: cardiac monitoring; Diagnostic Test: skin resistance; Device: Music listening |
| Control | Active comparator | patients wear headphones for 30 minuts without any sound Receives: Diagnostic Test: questionnaire; Diagnostic Test: laboratory test; Diagnostic Test: cardiac monitoring; Diagnostic Test: skin resistance; Device: No sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac monitoring
cardiac variability
Measured: through study period (to 15 min before the application of headphones until 15 minutes after their removal
Secondary outcomes (2)
questionnaire
anxiety questionnarie
Measured: questionnaire score change 15 min after the removal of headphones from baseline ( early before the application of headphones)
laboratory test
enzyme dosage
Measured: enzyme level change early after the application of headphones from baseline (early before the application of headphones)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start15 Feb 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cotoia Antonella, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171753
- Sponsor's protocol ID
- 5/CE/2016
- Status last verified
- Sep 2017
- First submitted
- 24 May 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety, Preoperative Stress and Music Therapy
- ClinicalTrials.gov ID
- NCT03171753
- Acronym / sponsor ID
- 5/CE/2016
- Conditions
- Anxiety State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music therapy | Experimental | Diagnostic Test: questionnaire, Diagnostic Test: laboratory test, Diagnostic Test: cardiac monitoring, Diagnostic Test: skin resistance, Device: Music listeningListening prerecorded music through an individual headset for 30 min in before the induction of anesthesia |
| Control | Active comparator | Diagnostic Test: questionnaire, Diagnostic Test: laboratory test, Diagnostic Test: cardiac monitoring, Diagnostic Test: skin resistance, Device: No soundpatients wear headphones for 30 minuts without any sound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective surgical patients >18 years old, after obtaining informed consent
Key exclusion criteria (5 listed)
- patients with hearing impairment,
- any known psychiatric or memory disorder
- thyroid disease.
- atrial fibrillation
- pace-maker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairequestionnarie will be performed before the application of headphone and after their removal. | Diagnostic test | Control, Music therapy |
| laboratory testlaboratory test will be collected before the application of headphone and after their removal. the cardiac monitoring will be performed during the all study period | Diagnostic test | Control, Music therapy |
| cardiac monitoringthe cardiac monitoring will be performed through study period | Diagnostic test | Control, Music therapy |
| skin resistancethe skin resistance monitoring will be performed through study period | Diagnostic test | Control, Music therapy |
| Music listeningListening prerecorded music through an individual headset for 30 min | Device | Music therapy |
| No soundNo sound through an individual headset for 30 min | Device | Control |
Primary outcome
cardiac monitoring
Time frame: through study period (to 15 min before the application of headphones until 15 minutes after their removal
cardiac variability
2 secondary outcomes
questionnaire
Time frame: questionnaire score change 15 min after the removal of headphones from baseline ( early before the application of headphones)
laboratory test
Time frame: enzyme level change early after the application of headphones from baseline (early before the application of headphones)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire, laboratory test and cardiac monitoring in people with Anxiety State, run by University of Foggia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac monitoring (time frame: through study period (to 15 min before the application of headphones until 15 minutes after their removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.