Improving the mental performance of sports science students in 2 weeks: a controlled experiment on the strength of bioacoustic correction

ISRCTN	ISRCTN15263884
DOI	https://doi.org/10.1186/ISRCTN15263884
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	University of Novi Sad
Funder	Provincial Secretariat for Higher Education and Scientific Research, Ministry of Science, Technological Development and Innovation, Serbia (142-451-3098)

Submission date: 04/02/2024
Registration date: 13/05/2024
Last edited: 13/05/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The aim of this study was to assess the effectiveness of a bioacoustic correction (BAC) program in increasing the concentration and attention parameters of sports science and physical education students.

Who can participate?
Sports science students aged 18 to 25 years who do not have acoustic problems can participate in this study

What does the study involve?
The study involves a daily bioacoustic program to reduce stress levels and increase attention and concentration. The lessons involve participation in 20-minute sessions 6 days a week, without additional treatments outside the laboratory. Before and after the experiment, a series of tests are selected and implemented to determine parameters related to attention and concentration.

What are the possible benefits and risks of participating?
The bioacoustic correction (BAC) program could improve the stability of attention, concentration and other cognitive abilities in participants. This could translate into a better ability to concentrate while studying and improvements in academic performance.
Stress reduction is an important benefit that could come from participating in the BAC program. By reducing stress levels, participants can experience a better quality of life and greater psychological well-being.
Bioacoustic correction could have positive effects on mental health, reducing anxiety and improving mood. This could be especially helpful for college students facing academic pressure and stress.
The BAC program is non-invasive and does not require taking drugs or using medical devices. This makes it a safe and accessible option for improving cognitive performance and reducing stress.
Although the BAC program is generally considered safe, unwanted side effects, such as headache, dizziness, or fatigue, may occur in some individuals. It is important that participants are aware of these potential risks.

Where is the study run from?
University of Novi Sad (Serbia)

When is the study starting and how long is it expected to run for?
October 2022 to December 2022

Who is funding the study?
Provincial Secretariat for Higher Education and Scientific Research, Ministry of Science, Technological Development and Innovation (Serbia)

Who is the main contact?
Prof. Patrick Drid, patrikdrid@gmail.com

Contact information

Prof Sergej Ostojic
Public, Scientific

Lovcenska 16
Novi Sad
21000
Serbia

ORCID ID	0000-0002-7270-2541
Phone	+381 (0)21/450-188
Email	sergej.ostojic@uns.ac.rs

Dr Carlo Rossi
Principal investigator

Via Giovanni Pascoli 6
Palermo
90144
Italy

ORCID ID	0000-0002-1208-1034
Phone	+39 (0)3886311467
Email	carlo.rossi@unipa.it

Study information

Primary study design	Interventional
Study design	Interventional randomized controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effects of a 14-day bioacoustic correction program on neuropsychological parameters in sports science students: a randomized controlled clinical trial
Study objectives	The hypothesis was that the bioacoustic intervention program provides positive effects regarding neuropsychological parameters in sport science students.
Ethics approval(s)	Approved 12/10/2022, Ethics committee of the University of Novi Sad (Lovcenska 16, Novi Sad, 21000, Serbia; +381 (0)21 450 188; sergej.ostojic@uns.ac.rs), ref: 48-10-2022-1
Health condition(s) or problem(s) studied	Neuropsychological parameters in sports science students
Intervention	The randomization was carried out by choosing a group using a number. The control group did not receive any intervention. The experimental group received a bioacoustic correction program (a method of EEG-dependent biofeedback) for 2 weeks. The classes involved attending sessions for 20 minutes 6 days a week. During the lesson, the participants had to listen to a music session while simultaneously registering EEG potentials in four leads (two frontal and two occipital). EEG recording was performed using four channels at points Fp1, Fp2, O1, and O2 as unipolar recordings relative to combined ear electrodes. Furthermore, the participants were asked to follow and concentrate on the flow of the musical pattern. An important factor was the volume level, which should have been loud enough but not annoying.
Intervention type	Other
Primary outcome measure(s)	1. Attention stability measured using the Bourdon test at baseline and after 2 weeks 2. Concentration measured using the Bourdon test at baseline and after 2 weeks 3. Mistakes measured using the Bourdon test at baseline and after 2 weeks 4. Signs measured using the Bourdon test at baseline and after 2 weeks 5. Concentration measured using the Landolt test at baseline and after 2 weeks 6. Switch ability measured using the Landolt test at baseline and after 2 weeks 7. Temp measured using the Landolt test at baseline and after 2 weeks 8. Mistakes measured using the Landolt test at baseline and after 2 weeks 9. Signs measured using the Landolt test at baseline and after 2 weeks 10. Effects of the bioacoustic correction program measured using the Toulouse-Pieron test at baseline and after 2 weeks 11. Effects of the bioacoustic correction program measured using the Schulte-table test at baseline and after 2 weeks
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	05/12/2022

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	25 Years
Sex	All
Target sample size at registration	16
Total final enrolment	20
Key inclusion criteria	University sports science students without neuropsychological diseases
Key exclusion criteria	Did not attend every session of the bioacoustic intervention
Date of first enrolment	01/11/2022
Date of final enrolment	15/11/2022

Locations

Countries of recruitment

Serbia

Study participating centre

University of Novi Sad

Faculty of Sport and Physical Education
Lovcenska 16
Novi Sad
21000
Serbia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from Carlo Rossi (carlo.rossi@unipa.it). Upon request, the main Excel document is shared where the data from which the statistical analysis was carried out and the conclusions reached are found. The data will be available from the publication of the study onwards. Data is provided upon request, but the full names and surnames of the participants and other private information will not be present.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/02/2024: Study's existence confirmed by the ethics committee of the University of Novi Sad.