NCT05510921

Brief Summary

This project aims to investigate the effects of an intervention involving minimalist piano music and bird singing on the anxiety of nursing professionals working in the Oncology sector of a hospital.

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 Oct 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

August 19, 2022

Last Update Submit

March 10, 2025

Conditions

Anxiety Disorders and Symptoms

Keywords

Nursing professionalsAnxietyOncologyMusicNature

Outcome Measures

Primary Outcomes (1)

  • Change from baseline levels of anxiety at immediately post intervention

    To assess the anxiety of the study participant, the reduced scale of trait anxiety (STAI-S-6), validated in Brazil in a large sample of Brazilians, will be used. There are 6 questions that assess how the individual is feeling at the present moment and can be answered with 4 options on a 4-point Likert scale: 1- almost never; 2- sometimes; 3- frequently; 4- almost always. This gives a score range from 6 to 24. To create scores compatible with the original STAI-S scores, the STAI-6 scores will be divided by 6 and multiplied by 20 to give a range from 20 to 80.STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

    immediately pre intervention and immediately post intervention.

Study Arms (3)

Control group

NO INTERVENTION

The control group will not receive any intervention

Minimalist music group

EXPERIMENTAL

a live session of minimalist music piano piece

Other: Minimalist music group

Minimalist music plus birdsongs group

EXPERIMENTAL

a live session of minimalist music piano piece with the superposition of bird song sounds

Other: Minimalist music + birdsongs group

Interventions

Minimalist music groupOTHER

Participants in this group will listen individually a live session of minimalist music piano piece, in a break room in the oncology sector, lasting between 10 and 15 minutes.

Minimalist music group
Minimalist music + birdsongs groupOTHER

Participants in this group will listen individually a live session of minimalist music piano piece with the superposition of bird song sounds, in a break room in the oncology sector, lasting between 10 and 15 minutes.

Minimalist music plus birdsongs group

Eligibility Criteria

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

You may qualify if:

  • Nursing professionals working in oncology Unit
  • Over 18 years old

You may not qualify if:

  • Nursing professionals who, for whatever reason, are unable to fully participate of the proposed musical intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652 900, Brazil

Location

Related Publications (1)

  • Leao ER, Dal Fabbro DR, Oliveira RB, Santos IR, Victor ED, Aquarone RL, Andrade CB, Ribeiro VF, Oliveira RC, Friedlander R, Ferreira DS. Stress, self-esteem and well-being among female health professionals: A randomized clinical trial on the impact of a self-care intervention mediated by the senses. PLoS One. 2017 Feb 27;12(2):e0172455. doi: 10.1371/journal.pone.0172455. eCollection 2017.

    PMID: 28241070BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersNeoplasms

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Eliseth R Leão, PhD

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior research scientist

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 22, 2022

Study Start

October 1, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)