Effect of Vibroacoustic Therapy on Acute Stress in University Students
Research of Music Therapy in the Development of Persons With Special Needs
1 other identifier
interventional
420
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2020
CompletedFirst Posted
Study publicly available on registry
March 3, 2020
CompletedStudy Start
First participant enrolled
June 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedJune 4, 2021
June 1, 2021
1.3 years
January 24, 2020
June 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
subjective stress perception
Subjective stress perception measured by Visual Analogue Scales for Stress and Perceived Stress Scales-10, Czech version.
1 day
Spectral analysis of heart rate variability
Spectral analysis of heart rate variability to measure the response of autonomous nervous system response measured by VLV Lab.
1 day
Galvanic skin response
Galvanic skin response to measure the response of autonomous nervous system response measured by VLV Lab.
1 day
Salivary cortisol
Salivary cortisol to measure the level of cortisol by Salivette Cortisol.
1 day
Study Arms (2)
music with low-sinusoidal sound (vibrations)
EXPERIMENTALParticipants will listen to music and low-sinusoidal sound (vibroacoustic therapy).
Control Group
PLACEBO COMPARATORParticipants will listen to music alone.
Interventions
listening to low-frequency sound of 40 Hz with biorhythmic sequential modulation combined to music
Eligibility Criteria
You may qualify if:
- participants want to voluntarily participate in the study,
- they are 18-30 years old,
- they are of Czech or Slovak nationality,
- full-time students.
You may not qualify if:
- psychiatric diagnosis,
- neurologic disease (e.g. epilepsy, cerebral palsy) or any known contraindication of vibro-acoustic therapy such as muscle hypotonia, angina pectoris, psychotic or acute post-traumatic and bleeding,
- post-traumatic stress disorder,
- perceived pain,
- persons after sleep deprivation,
- substance abuse (caffeine, nicotine) on the day of experiment and in case of strong addictive substances (alcohol, drugs) 1 day before the experiment,
- increased physical activity on the day before the experiment,
- menstruation on the day of the experiment,
- moderate to high food intake on the day of the experiment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Education, Palacký University Olomouc
Olomouc, 79900, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiri Kantor, PhD
Faculty of Education, Palacky University, Olomouc, Czech Republic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 24, 2020
First Posted
March 3, 2020
Study Start
June 2, 2021
Primary Completion
September 30, 2022
Study Completion
December 30, 2022
Last Updated
June 4, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- From July 2021 - on
Only a dean and dean-deputy (as trial investigators) will be allowed an access to the full dataset before their publication based on a formal request.