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Effect of Vibroacoustic Therapy on Acute Stress in University Students

NCT04293848 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2021-06-04

No results posted yet for this study

Summary

The goal of the planned Randomized Control Trial is to explore the effect of vibroacoustic therapy on acute stress of university students. The theoretical framework of the study is based on biopsychosocial model of stress and multimodal approach to measurement. The trial is designed as single-blinded, placebo-controlled, with participants individually randomized into two parallel-groups, including equal randomization and blocked allocation of participants. 420 participants are all full-time university students (18-30 years) and will be divided into two groups: an experimental group (receiving low vibrations combined with music) and a control group (only music without low-frequency sounds). For both groups acute stress response will be measured by spectral analysis of heart rate variability (HRV SA), galvanic skin response (GSR), salivary cortisol, standardized psychological questionnaires - visual analogue scales for stress (VAS-stress) and Perceived Stress Scales-10, Czech version (PSS-10). It is expected that the experimental group will demonstrate a lower level of stress response that will be measured by higher activity of parasympathetic activity, lower level of skin resistance, lower level of salivary cortisol and lower subjective perception of stress. If vibroacoustic therapy turns out to be effective, it can be viewed as safe, student-friendly and inexpensive prevention of stress-related health problems and promote the health of students in the course of university education.

Conditions

  • Stress, Psychologic

Interventions

OTHER

Vibroacoustic therapy

listening to low-frequency sound of 40 Hz with biorhythmic sequential modulation combined to music

OTHER

Only music (no vibrations)

listening to music, no vibrations

Sponsors & Collaborators

  • Palacky University

    lead OTHER

Principal Investigators

  • Jiri Kantor, PhD · Faculty of Education, Palacky University, Olomouc, Czech Republic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2022-09-30
Completion
2022-12-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04293848 on ClinicalTrials.gov