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. 2022 Jun 1;10(6):1024. doi: 10.3390/healthcare10061024
INFORMED CONSENT
For research project: VAS (project IGA)
Implementation period: 4-2019/2-2020
project leader: doc. Mgr. Jiří Kantor, Ph.D.

Madam, sir,
We are writing to you to ask you to collaborate on a research project involving an experiment involving listening to sounds and taking measurements before, during and after the experiment using the methods listed below. All procedures used during the experiment and measurements are non-invasive and safe, except for the risks listed below. Only nature sounds and low frequency sounds will be used in the experiment.

The purpose of the study is to investigate the effect of the sounds used in the experiment on the human body.

Measurement methods:
The composition of data collection methods includes non-invasive instrumental and psychological test instruments:
  • An initial questionnaire to obtain personal and demographic data, such as age, gender, incidence of health problems, etc. and other specific questions related to current psychosomatic status.

  • Analysis of heart rate variability using frequency and time indices.

  • Blood pressure and respiratory rate measurements.

  • Visual analogue scales to detect differences in subjective perception of stress levels.

  • UWIST Mood Adjective Checklist to determine the difference in emotional tuning before and after the intervention.

  • The standardised Perceived Stress Scale questionnaire (Cohen, 1983) in the Czech version called the “Škály vnímaného stresu”, as presented by Buršíková Brabcová and Kohout (2018).

  • Interview to supplement data of a rather qualitative nature.


Time Schedule:
The total length of one session is 60 min and will take place once a week, always on the same day and time. There will be a total of three sessions, so the length of participation in the research is three weeks. The measurements will take place at two university departments, PdF and FTK. The results of the research will be shared after the study is completed.

The following risks are known for the intervention implemented in the research experiment:
  • Hypotonia

  • Angina pectoris

  • Psychotic states

  • Post-traumatic conditions

  • Open bleeding

The participant of the study acknowledges by his/her signature (below) that he/she does not suffer from any of the above mentioned risks at the time of the experiment.

The participant of the study agrees:
  • To avoid intake of addictive substances in the morning hours before the experiment (drinks containing caffeine and tannin, cigarettes) and strong addictive substances the day before the experiment (alcohol, marijuana).

  • With taking heart rate recordings, blood pressure measurements and audio recording of the qualitative interview.

  • With anonymous direct quotation of the data from the interview.

  • With the retention of all research records, which will be used anonymously only for the purposes of the research study.


Statement
I declare that I agree to participate in the project mentioned above. I have been informed by the project leader about the nature of the research and have been informed about the objectives and the methods and procedures that will be used in the research, as well as the benefits and risks for me of participating in the project. I agree that all data collected will be used for research purposes only and that the results of the research may be published anonymously.

I have had the opportunity to consider everything properly, calmly and in sufficient time. I have had the opportunity to ask the researcher everything I considered essential and necessary to know. I received a clear and understandable answer to these questions. I am informed that I have the possibility to withdraw from the project at any time, even without giving a reason.

The researcher declares that personal information that could identify the research participant will not be passed on to anyone or appear in any publication outputs. Personal data will be protected in accordance with applicable legislation.

This informed consent is made in two copies, each with the validity of an original, one of which will be given to me (or my legal representative) and the other to the project investigator.

Name, surname and signature of the project leader:

____________________________________________________________

In______________________ on:_________________________________


Name, surname and signature of the participant in the project:

____________________________________________________________

In______________________ on:_________________________________