NCT06590363

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable anxiety

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

August 31, 2024

Last Update Submit

September 6, 2024

Conditions

Keywords

musicanxietyheart rateblood pressureappointment

Outcome Measures

Primary Outcomes (1)

  • 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).

    16 weeks

Secondary Outcomes (2)

  • Heart rate

    16 weeks

  • Blood Pressure

    16 weeks

Study Arms (2)

Music

EXPERIMENTAL

Corresponded to patients and doctors subjected to the period of listening to zen music in the appointment.

Other: Listening to zen music

Non-Music

NO INTERVENTION

Corresponded to patients and doctors not subjected to the period of listening to zen music.

Interventions

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.

Music

Eligibility Criteria

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

You may qualify if:

  • scheduled appointment;
  • agree to participate in the clinical trial.

You may not qualify if:

  • years or younger;
  • deaf;
  • illiterate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cátia Valesca Nunes Solis

Coimbra, Coimbra District, 3000-317, Portugal

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2024

First Posted

September 19, 2024

Study Start

January 1, 2024

Primary Completion

April 14, 2024

Study Completion

April 14, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations