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Evaluation of the Minimalist Music and Birdsongs in the Anxiety of Nursing Professionals in Oncology

Primary Purpose

Anxiety Disorders and Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Minimalist music group
Minimalist music + birdsongs group
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety Disorders and Symptoms focused on measuring Nursing professionals, Anxiety, Oncology, Music, Nature

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Hospital Israelita Albert EinsteinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Minimalist music group

Minimalist music plus birdsongs group

Arm Description

The control group will not receive any intervention

a live session of minimalist music piano piece

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
August 19, 2022
Last Updated
February 27, 2023
Sponsor
Hospital Israelita Albert Einstein
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1. Study Identification

Unique Protocol Identification Number
NCT05510921
Brief Title
Evaluation of the Minimalist Music and Birdsongs in the Anxiety of Nursing Professionals in Oncology
Official Title
Evaluation of the Minimalist Music and Birdsongs in the Anxiety of Nursing Professionals in Oncology: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Israelita Albert Einstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The demand for care with mental health of nursing professionals is increasingly present, considering the high rate of anxiety symptoms presented by the teams providing health care within hospitals. Oncology is one of the sectors where professionals have constant contact with situations of suffering and death, being a place where the enlargement of therapeutic tools for handling anxiety symptoms may bring benefits. Scientific literature has never described the effectiveness of works with minimalist music and birds singing used simultaneously with anxiety relief resources. Objective: Assess the effects of music intervention, with minimalist repertoire, with or without association to birds singing over anxiety of nursing professionals that work in Oncology. Method: Randomized Clinical controlled trial. The study will be performed in the Oncology sector of Israeli Hospital Albert Einstein located in São Paulo, Brazil and the population consists in 100 nursing professionals. The intervention will consist in a musical part, especially developed for this study and in recording of birds singing, played live for each one of the participants, individually with 10 to 15 minutes duration. The instrument for anxiety assessment chosen for this project is short-form of state-trait anxiety inventory (STAI-S-6). The project was approved by the research ethics committee, whose identification number on Plataforma Brasil (CAAE) is 59498222.6.0000.0071

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders and Symptoms
Keywords
Nursing professionals, Anxiety, Oncology, Music, Nature

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will not receive any intervention
Arm Title
Minimalist music group
Arm Type
Experimental
Arm Description
a live session of minimalist music piano piece
Arm Title
Minimalist music plus birdsongs group
Arm Type
Experimental
Arm Description
a live session of minimalist music piano piece with the superposition of bird song sounds
Intervention Type
Other
Intervention Name(s)
Minimalist music group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Minimalist music + birdsongs group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline levels of anxiety at immediately post intervention
Description
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).
Time Frame
immediately pre intervention and immediately post intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Nursing professionals working in oncology Unit Over 18 years old Exclusion Criteria: Nursing professionals who, for whatever reason, are unable to fully participate of the proposed musical intervention.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eliseth R. Leão, PhD
Phone
1199618-6489
Ext
55
Email
eliseth.leão@einstein.br
First Name & Middle Initial & Last Name or Official Title & Degree
Fernanda HM Abrahão, B.Sc
Phone
11992987170
Ext
55
Email
feabrahao033@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliseth R Leão, PhD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
State/Province
SP
ZIP/Postal Code
05652 900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aline HM Pacífico, M.Sc
Phone
+551121513000
Email
aline.pacifico@einstein.br
First Name & Middle Initial & Last Name & Degree
Thomaz R Silva, PhD
First Name & Middle Initial & Last Name & Degree
Fernanda HM Abrahao, B.Sc
First Name & Middle Initial & Last Name & Degree
Eliseth R Leão, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28241070
Citation
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.
Results Reference
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Evaluation of the Minimalist Music and Birdsongs in the Anxiety of Nursing Professionals in Oncology

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