Stress, PsychologicNCT04293848
Effect of Vibroacoustic Therapy on Acute Stress in University Students
A study testing Vibroacoustic therapy and Only music (no vibrations) in people with Stress, Psychologic, run by Palacky University at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychologic
- What is being tested?
- Vibroacoustic therapy and Only music (no vibrations)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteCzechia
- Study dates
- 2 Jun 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- participants want to voluntarily participate in the study,
- they are 18-30 years old,
- they are of Czech or Slovak nationality,
- full-time students.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Faculty of Education, Palacký University Olomouc
Olomouc, 79900
About this study
Official title: Research of Music Therapy in the Development of Persons With Special Needs
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.
Read the detailed description
Primary objective: to explore whether application of vibroacoustic therapy has more significant effect on eliminating acute stress response in university students than music alone.
Research question: "Does the application of vibroacoustic therapy (low frequency vibration with music) show a more significant effect on decreasing an acute stress response (measured by HRV SA, GSR, salivary cortisol) and perception of stress (measured on VAS) in university students compared to listening to music without technologically modified low-vibrations?"
Participants: The recruitment of suitable research participants will be carried out among students studying at Faculty of Education at Palacky University in Olomouc, Czech Republic, provided that all inclusive criteria are met. Participants will be recruited by three researchers via mail and personal contact with students at the start of each of two semesters of one academic year. Only students with medium or high levels of acute stress will participate on the research experiment (level of stress measured by PSS-10, min. 20 points are required from participants). Recruiting process will be coordinated and overseen by a recruitment coordinator. Sequentially numbered, opaque, sealed envelopes will be used as a mechanism for allocation concealment. The allocation sequence will be generated at a remote workplace by a specialist not participating in enrollment and assignment of participants for the intervention.
It is a parallel group, two arms, superiority trial with 1.1. allocation ratio. Equal blocked randomization (with block size 8) with stratification according to the gender will be used here. The randomization scheme will determine which persons will be placed in the intervention group and the control group (placebo) The randomization will be implemented by a computerized random number generator (program Sealed Envelope).
The intervention is triple-blinded (blinded will be participants, statisticians as well as outcome measurements). Considering one-shot character of research experiment in every participant possibility of emergency unblinding has not been considered, nor systematic plans to promote participants´ retention and complete follow-up have not been created.
Research experiment: After recruitment students will be divided into the experimental or control groups by means of randomization. Experimental group will get full intervention including music with low-frequency sound. Control group will listen to the same music as planned for experimental group without the low-frequency sound in the frequency range 20-100 Hz (no vibrations). Measurements in two parallel groups will be carried out by two trained persons under supervision by a psychologist, physiological measurement experts and a research coordinator overseeing adherence to experimental protocols.
Measurements: The measurement methods consist of (1) heart rate variability spectral analysis, (2) galvanic skin response, (3) salivary cortisol, (4) Perceived Stress Scale questionnaire, (5) visual analogue scales for stress and (6) a questionnaire of own construction.
Statistical analysis: Data analysis methods will be based on statistical processing in the form of the one-way (factor Vibroacoustic/Placebo) repeated measures (factor Before/After) ANOVA. The intervention arm will be compared against the control for all primary analyses and significant differences in the responses of autonomous nervous system, salivary cortisol and the stress perception will be examined.
Hypotheses:
H1: Listening to vibroacoustic therapy recording (music with low-frequency vibrations) will stimulate higher levels of parasympathetic nervous activity compared to listening to music alone.
H2: Listening to vibroacoustic therapy recording (music with low-frequency vibrations) will stimulate lower levels of salivary cortisol compared to listening to music alone.
H3: Listening to vibroacoustic therapy recording (music with low-frequency vibrations) will stimulate lower levels of subjective perception of stress compared to listening to music alone.
- Conditions
- Stress, Psychologic
- Being tested
- Vibroacoustic therapy, Only music (no vibrations)
- Keywords
- vibroacoustic therapy
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibroacoustic therapyOther
Also called music with low-frequency sound treatment
listening to low-frequency sound of 40 Hz with biorhythmic sequential modulation combined to music
Only music (no vibrations)Other
listening to music, no vibrations
| Study group | Role | What they receive |
|---|---|---|
| music with low-sinusoidal sound (vibrations) | Experimental | Participants will listen to music and low-sinusoidal sound (vibroacoustic therapy). Receives: Other: Vibroacoustic therapy |
| Control Group | Placebo comparator | Participants will listen to music alone. Receives: Other: Only music (no vibrations) |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective stress perception
Subjective stress perception measured by Visual Analogue Scales for Stress and Perceived Stress Scales-10, Czech version.
Measured: 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.
Measured: 1 day
Galvanic skin response
Galvanic skin response to measure the response of autonomous nervous system response measured by VLV Lab.
Measured: 1 day
Salivary cortisol
Salivary cortisol to measure the level of cortisol by Salivette Cortisol.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start2 Jun 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sequentially numbered, opaque, sealed envelopes will be used as a mechanism for allocation concealment. The allocation sequence will be generated on a remote workplace by a specialist not participating on enrollment and assigning participants to intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiří Kantor, Palacky University
- Investigators
- Jiri Kantor, PhD, Principal investigator, Faculty of Education, Palacky University, Olomouc, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293848
- Sponsor's protocol ID
- IGA_2019_004
- Status last verified
- Jun 2021
- First submitted
- 24 Jan 2020
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Music Therapy in the Development of Persons With Special Needs
- ClinicalTrials.gov ID
- NCT04293848
- Acronym / sponsor ID
- IGA_2019_004
- Conditions
- Stress, Psychologic
- Keywords
- vibroacoustic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary objective: to explore whether application of vibroacoustic therapy has more significant effect on eliminating acute stress response in university students than music alone.
Research question: "Does the application of vibroacoustic therapy (low frequency vibration with music) show a more significant effect on decreasing an acute stress response (measured by HRV SA, GSR, salivary cortisol) and perception of stress (measured on VAS) in university students compared to listening to music without technologically modified low-vibrations?"
Participants: The recruitment of suitable research participants will be carried out among students studying at Faculty of Education at Palacky University in Olomouc, Czech Republic, provided that all inclusive criteria are met. Participants will be recruited by three researchers via mail and personal contact with students at the start of each of two semesters of one academic year. Only students with medium or high levels of acute stress will participate on the research experiment (level of stress measured by PSS-10, min. 20 points are required from participants). Recruiting process will be coordinated and overseen by a recruitment coordinator. Sequentially numbered, opaque, sealed envelopes will be used as a mechanism for allocation concealment. The allocation sequence will be generated at a remote workplace by a specialist not participating in enrollment and assignment of participants for the intervention.
It is a parallel group, two arms, superiority trial with 1.1. allocation ratio. Equal blocked randomization (with block size 8) with stratification according to the gender will be used here. The randomization scheme will determine which persons will be placed in the intervention group and the control group (placebo) The randomization will be implemented by a computerized random number generator (program Sealed Envelope).
The intervention is triple-blinded (blinded will be participants, statisticians as well as outcome measurements). Considering one-shot character of research experiment in every participant possibility of emergency unblinding has not been considered, nor systematic plans to promote participants´ retention and complete follow-up have not been created.
Research experiment: After recruitment students will be divided into the experimental or control groups by means of randomization. Experimental group will get full intervention including music with low-frequency sound. Control group will listen to the same music as planned for experimental group without the low-frequency sound in the frequency range 20-100 Hz (no vibrations). Measurements in two parallel groups will be carried out by two trained persons under supervision by a psychologist, physiological measurement experts and a research coordinator overseeing adherence to experimental protocols.
Measurements: The measurement methods consist of (1) heart rate variability spectral analysis, (2) galvanic skin response, (3) salivary cortisol, (4) Perceived Stress Scale questionnaire, (5) visual analogue scales for stress and (6) a questionnaire of own construction.
Statistical analysis: Data analysis methods will be based on statistical processing in the form of the one-way (factor Vibroacoustic/Placebo) repeated measures (factor Before/After) ANOVA. The intervention arm will be compared against the control for all primary analyses and significant differences in the responses of autonomous nervous system, salivary cortisol and the stress perception will be examined.
Hypotheses:
H1: Listening to vibroacoustic therapy recording (music with low-frequency vibrations) will stimulate higher levels of parasympathetic nervous activity compared to listening to music alone.
H2: Listening to vibroacoustic therapy recording (music with low-frequency vibrations) will stimulate lower levels of salivary cortisol compared to listening to music alone.
H3: Listening to vibroacoustic therapy recording (music with low-frequency vibrations) will stimulate lower levels of subjective perception of stress compared to listening to music alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sequentially numbered, opaque, sealed envelopes will be used as a mechanism for allocation concealment. The allocation sequence will be generated on a remote workplace by a specialist not participating on enrollment and assigning participants to intervention.
| Arm | Type | Receives |
|---|---|---|
| music with low-sinusoidal sound (vibrations) | Experimental | Other: Vibroacoustic therapyParticipants will listen to music and low-sinusoidal sound (vibroacoustic therapy). |
| Control Group | Placebo comparator | Other: Only music (no vibrations)Participants will listen to music alone. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- participants want to voluntarily participate in the study,
- they are 18-30 years old,
- they are of Czech or Slovak nationality,
- full-time students.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibroacoustic therapyAlso: music with low-frequency sound treatmentlistening to low-frequency sound of 40 Hz with biorhythmic sequential modulation combined to music | Other | music with low-sinusoidal sound (vibrations) |
| Only music (no vibrations)listening to music, no vibrations | Other | Control Group |
Primary outcome
subjective stress perception
Time frame: 1 day
Subjective stress perception measured by Visual Analogue Scales for Stress and Perceived Stress Scales-10, Czech version.
Spectral analysis of heart rate variability
Time frame: 1 day
Spectral analysis of heart rate variability to measure the response of autonomous nervous system response measured by VLV Lab.
Galvanic skin response
Time frame: 1 day
Galvanic skin response to measure the response of autonomous nervous system response measured by VLV Lab.
Salivary cortisol
Time frame: 1 day
Salivary cortisol to measure the level of cortisol by Salivette Cortisol.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiri Kantor, PhD principal investigator
Faculty of Education, Palacky University, Olomouc, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibroacoustic therapy and Only music (no vibrations) in people with Stress, Psychologic, run by Palacky University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiri Kantor, PhD (+420725458439, jiri.kantor@upol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective stress perception (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.