NCT04293848

Effect of Vibroacoustic Therapy on Acute Stress in University Students

Status unknown NA Last updated 4 June 2021

What this trial tests

NA trial testing Vibroacoustic therapy in Stress, Psychologic in 420 participants. Status unknown.

Timeline

2 June 2021

Primary endpoint
30 September 2022

30 December 2022

Quick facts

Lead sponsor	Palacky University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	420
Start date	2 June 2021
Primary completion	30 September 2022
Estimated completion	30 December 2022
Sites	1 location across Czechia

Drugs / interventions tested

• Vibroacoustic therapy
• Only music (no vibrations)

Conditions studied

• Stress, Psychologic — all drugs for Stress, Psychologic →

Sponsor

Palacky University

Who can join

Adults 18 to 30, any sex, with Stress, Psychologic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of low frequency sound vibration on acute stress response in university students-Pilot randomized controlled trial.
   Kantor J, Vilímek Z, Vítězník M, Smrčka P, et al · · 2022 · cited 4× · PMID 36312194 · DOI 10.3389/fpsyg.2022.980756
2. The Effect of Low Frequency Sound on Heart Rate Variability and Subjective Perception: A Randomized Crossover Study.
   Vilímek Z, Kantor J, Krejčí J, Janečka Z, et al · · 2022 · cited 3× · PMID 35742075 · DOI 10.3390/healthcare10061024