AnxietyNCT06590363
The Effect of Music on Anxiety in the Appointment Period
A study testing Listening to zen music in people with Anxiety, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
Trial summary
The goal of this randomized clinical trial is to learn if musical intervention can reduce anxiety on patients and doctors in the appointment period. The main questions it aims to answer are: Can music reduce the psychological symptoms of anxiety at the end of the appointment? Can music reduce heart rate and blood… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Listening to zen music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2024to 14 Apr 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- scheduled appointment;
- agree to participate in the clinical trial.
Who cannot join
- 17 years or younger;
- deaf;
- illiterate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Musical Intervention in Anxiety on Patients and Doctors in the Appointment Period
The goal of this randomized clinical trial is to learn if musical intervention can reduce anxiety on patients and doctors in the appointment period. The main questions it aims to answer are:
Can music reduce the psychological symptoms of anxiety at the end of the appointment? Can music reduce heart rate and blood pressure at the end of the appointment?
Researchers will compare if the presence of zen music during the appointment influences anxiety levels.
Participants in the intervention group will listen to music during the appointment. Those in the control group will not have music in the office during the appointment.
- Conditions
- Anxiety
- Being tested
- Listening to zen music
- Keywords
- music, anxiety, heart rate, blood pressure, appointment
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to zen musicOther
We conducted a quasi-randomized controlled clinical trial with two groups: Intervention Group (I), which corresponded to patients and doctors who underwent the period of musical listening in the office; and the Control Group (C), composed of patients and doctors who did not undergo the period of musical listening.
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Corresponded to patients and doctors subjected to the period of listening to zen music in the appointment. Receives: Other: Listening to zen music |
| Non-Music | No intervention | Corresponded to patients and doctors not subjected to the period of listening to zen music. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Participants achieved a response if they scored of the State-Trait Anxiety Inventory reduze in the end of the appointment.
STAI scores are classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Measured: 16 weeks
Secondary outcomes (2)
Heart rate
Participants achieved a response if the heart rate reduze in the end of the appointment
Measured: 16 weeks
Blood Pressure
Participants achieved a response if the systolic and diastolic blood pressure reduze in the end of the appointment
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2024
- Primary completion14 Apr 2024
- Study completion14 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catia Valesca, Unidade Local de Saúde de Coimbra, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590363
- Sponsor's protocol ID
- 147-2023
- Status last verified
- Sep 2024
- First submitted
- 31 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Musical Intervention in Anxiety on Patients and Doctors in the Appointment Period
- ClinicalTrials.gov ID
- NCT06590363
- Acronym / sponsor ID
- 147-2023
- Conditions
- Anxiety
- Keywords
- music, anxiety, heart rate, blood pressure, appointment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPEUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 14 Apr 2024 (actual)
- Study completion
- 14 Apr 2024 (actual)
- First posted
- 19 Sep 2024 (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.
The goal of this randomized clinical trial is to learn if musical intervention can reduce anxiety on patients and doctors in the appointment period. The main questions it aims to answer are:
Can music reduce the psychological symptoms of anxiety at the end of the appointment? Can music reduce heart rate and blood pressure at the end of the appointment?
Researchers will compare if the presence of zen music during the appointment influences anxiety levels.
Participants in the intervention group will listen to music during the appointment. Those in the control group will not have music in the office during the appointment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: Listening to zen musicCorresponded to patients and doctors subjected to the period of listening to zen music in the appointment. |
| Non-Music | No intervention | –Corresponded to patients and doctors not subjected to the period of listening to zen music. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled appointment;
- agree to participate in the clinical trial.
Key exclusion criteria (3 listed)
- 17 years or younger;
- deaf;
- illiterate.
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 |
|---|---|---|
| Listening to zen musicWe conducted a quasi-randomized controlled clinical trial with two groups: Intervention Group (I), which corresponded to patients and doctors who underwent the period of musical listening in the office; and the Control Group (C), composed of patients and doctors who did not undergo the period of musical listening. | Other | Music |
Primary outcome
Anxiety
Time frame: 16 weeks
Participants achieved a response if they scored of the State-Trait Anxiety Inventory reduze in the end of the appointment. STAI scores are classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
2 secondary outcomes
Heart rate
Time frame: 16 weeks
Blood Pressure
Time frame: 16 weeks
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 19 Sep 2024.
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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 Listening to zen music in people with Anxiety, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
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 2 inclusion and 3 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 19 Sep 2024. 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 Portugal. 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?
Anxiety (time frame: 16 weeks). 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 19 Sep 2024.