Pain PerceptionMINTREPNCT02991014
Music-based Intervention for the Reduction of Pain
A study testing researcher-selected frequency-modulated music, researcher-selected non-modulated music and participant-selected non-modulated music in people with Pain Perception and Autonomic Nervous System Functioning, run by University of Vienna at 2 sites in 2 countries.
Trial summary
This study aims to compare the impact of listening to frequency-modulated music vs. non-modulated music (both researcher-selected), and to test whether there are differential effects on pain and stress perception. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Perception, Autonomic Nervous System Functioning
- What is being tested?
- researcher-selected frequency-modulated music, researcher-selected non-modulated music and participant-selected non-modulated music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2016to 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 18 - 35 years
- BMI: 18.5 - 30 kg/m²
- full command of the German language
- capability to attend ten sessions of music listening in our laboratory within three consecutive weeks, each for a duration of one hour
Who cannot join
- music related profession or studies
- absolute hearing (self-report)
- physical conditions (self-report): tinnitus, hearing impairments, extreme visual impairment, cardiovascular diseases, diabetes, artery occlusive disease, hyper-/hypotension, Raynaud syndrome, chronic pain condition
- pregnancy, breastfeeding
- current mental disorders (self-report): major depression, anxiety disorder, eating disorder, substance dependence, psychosis, schizophrenia
- regular intake of pain drugs/psychotropic drugs
- not being able to refrain from smoking for 2.5 hours
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
University of Vienna
Vienna, 1010
Urs M Nater, PhD, +43-1-4277 ext. 47220, urs.nater@univie.ac.at
Anja C Feneberg, MSc
Germany1 site
- Active, not recruiting
Philipps-University Marburg, Department of Psychology, Clinical Biopsychology
Marburg, Hesse, 35037
About this study
Official title: Music-based Intervention for the Reduction of Pain and Stress in Healthy Adults
This study aims to compare the impact of listening to frequency-modulated music vs. non-modulated music (both researcher-selected), and to test whether there are differential effects on pain and stress perception. Further, these two conditions will be compared to a third condition, in which participants will be exposed to self-selected non-modulated music. It is hypothesized that both researcher-selected frequency-modulated music and self-selected non-modulated music result in stronger decreases in stress and pain compared to researcher-selected non-modulated music, while it is expected that there will be no differences in researcher-selected frequency-modulated music and self-selected non-modulated music. The intervention consists of ten sessions of music listening in the course of three consecutive weeks.
Read the detailed description
This study aims to compare the impact of three different music listening interventions on stress and pain parameters. Participants will be assigned randomly to one of the conditions. In order to avoid expectancy-related effects, participants in both the researcher- and self-selected condition are told that they were allocated randomly to frequency-modulated or non-modulated music. Therefore, subjects are fully blinded with regards to frequency-modulation.
The study design is as follows:
- Baseline measurement: assessment of resting state biological parameters and questionnaires, CPT
- Music listening sessions: ten sessions in three consecutive weeks including:
- 60 minutes of music listening
- CPT following music listening (sessions 1, 3, 6, 10 only)
- Assessments: biological and subjective pain and stress parameters; music and mood related parameters
- Post measurement: assessment of resting state biological parameters and questionnaires, CPT
- Follow-up measurement: 4 weeks after intervention, assessment of resting state biological parameters and questionnaires, CPT
Participants respond to health-related questions (chronic stress, stress reactivity, sleep quality, fatigue, menstrual cycle phase) as well as mood and music-related questions at baseline, post-intervention, and follow-up which are assessed as potential outcome, moderator, and/or control variables. In addition, pain and stress parameters (both biological and subjective) are being assessed at baseline, post-intervention and follow-up as well as in the course of the ten music listening sessions. Furthermore, participants respond to specific music and mood related items following each music listening session (e.g. perceived valence, arousal, familiarity, liking, induced emotions, etc.).
It is hypothesized that listening to researcher-selected frequency-modulated music and self-selected non-modulated music results in stronger increases in pain tolerance and stronger decreases in pain intensity from baseline to post compared to listening to researcher-selected non-modulated music. Furthermore, stronger decreases in stress parameters (e.g. increases in HRV) from baseline to post are expected in the researcher-selected frequency-modulated music and self-selected non-modulated music than in the researcher-selected non-modulated music listening condition. Moreover, it is expected that there will be no differences in researcher-selected frequency-modulated music and self-selected non-modulated music with regards to pain and stress parameters. Additionally, it will be tested whether changes in pain parameters are being mediated* by changes in markers of stress-responsive systems (e.g. heart rate variability indices).
Finally, process analysis over the course of the music listening sessions sessions will be conducted with biological and subjective pain and stress indices as well as music and mood related parameters.
*Although checking for spelling mistakes before submitting the first record, a mistake in wording was discovered only after the release of the record and therefore corrected corresponding to our original hypothesis.
- Being tested
- researcher-selected frequency-modulated music, researcher-selected non-modulated music, participant-selected non-modulated music
- Keywords
- music intervention, heart rate variability, frequency modulation, pain perception, cold pressor test (CPT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
researcher-selected frequency-modulated musicBehavioural
Music pieces have been selected in advance by the researchers. Furthermore, musical frequencies have been artificially modulated.
researcher-selected non-modulated musicBehavioural
The same music pieces as in the active comparator arm have been selected in advance by the researchers, but no artificial frequency modulation.
participant-selected non-modulated musicBehavioural
Participants bring their own choice of personally preferred music pieces and listen to them during the intervention sessions. There is no frequency modulation in this condition.
| Study group | Role | What they receive |
|---|---|---|
| researcher-selected frequency-modulated music | Active comparator | Not described Receives: Behavioral: researcher-selected frequency-modulated music |
| researcher-selected non-modulated music | Placebo comparator | Not described Receives: Behavioral: researcher-selected non-modulated music |
| participant-selected non-modulated music | Experimental | Not described Receives: Behavioral: participant-selected non-modulated music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Tolerance
Cold pressor test (CPT): Duration in seconds from immersion of one hand into cold water until removal of the hand:
- baseline before music intervention
- post assessment after completion of music intervention (3 weeks)
Measured: Pre-Post-Change-Design: change from baseline to after 3 weeks
Pain Intensity
Cold pressor test (CPT): Subjective pain intensity of the test rated via visual analog scale at the time of removal of the hand
- baseline assessment before music intervention
- post assessment after completion of music intervention (3 weeks)
Measured: Pre-Post-Change-Design: change from baseline to after 3 weeks
Secondary outcomes (5)
Subjective Stress Experience
visual analog scales
- baseline assessment (before and after CPT)
- post assessment after completion of music intervention (before and after CPT)
- in each music listening session (T1: before music listening, T2: after 60 minutes music listening, before CPT; T3: after CPT)
Measured: Pre-Post-Change-Design: change from baseline to after 3 weeks; process analysis during the course of the intervention
Subjective Stress Experience
Measurements:
- chronic stress: SSCS (Screening scale of the TICS - Trier Inventory of Chronic Stress, assessed at baseline and post after completion of music intervention)
- stress reactivity: PSRS-23 (Perceived Stress Reactivity Scale, assessed at baseline and post after completion of music intervention)
Measured: Pre-Post-Change-Design: change from baseline to after 3 weeks
Physiological Stress: Heart Rate Variability Indices
Various parameters (e.g. RMSSD, HF, LF, HF/LF)
- resting state assessed at baseline and post after completion of music intervention
- continuous assessment in each music listening session
- assessment in response to CPT
Measured: Pre-Post-Change-Design: change from baseline to after 3 weeks, process analysis during the course of the intervention
Physiological Stress: Electrodermal activity (EDA)
skin conductance level, skin conductance response
- resting state assessed at baseline and post after completion of music intervention
- continuous assessment in each music listening session
- assessment in response to CPT
Measured: Pre-Post-Change-Design; change from baseline to after 3 weeks, process analysis during the course of the intervention
Physiological Stress: Hair Cortisol
Hair Cortisol assessment:
- baseline before music intervention
- follow-up assessment 4 weeks after post assessment
Measured: Pre-Post-Change-Design, change from baseline to 4 weeks after post assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain PerceptionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Urs Nater, University of Vienna
- Investigators
- Urs Nater, PhD, Principal investigator, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991014
- Sponsor's protocol ID
- MINTREP-UN
- Acronym
- MINTREP
- Status last verified
- Apr 2021
- First submitted
- 2 Dec 2016
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Feneberg AC, Kappert MB, Maidhof RM, Doering BK, Olbrich D, Nater UM. Efficacy, Treatment Characteristics, and Biopsychological Mechanisms of Music-Listening Interventions in Reducing Pain (MINTREP): Study Protocol of a Three-Armed Pilot Randomized Controlled Trial. Front Psychiatry. 2020 Nov 4;11:518316. doi: 10.3389/fpsyt.2020.518316. eCollection 2020.
PubMed 33329075
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music-based Intervention for the Reduction of Pain and Stress in Healthy Adults
- ClinicalTrials.gov ID
- NCT02991014
- Acronym / sponsor ID
- MINTREP / MINTREP-UN
- Keywords
- music intervention, heart rate variability, frequency modulation, pain perception, cold pressor test (CPT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Dec 2016 (estimated)
- 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.
This study aims to compare the impact of listening to frequency-modulated music vs. non-modulated music (both researcher-selected), and to test whether there are differential effects on pain and stress perception. Further, these two conditions will be compared to a third condition, in which participants will be exposed to self-selected non-modulated music. It is hypothesized that both researcher-selected frequency-modulated music and self-selected non-modulated music result in stronger decreases in stress and pain compared to researcher-selected non-modulated music, while it is expected that there will be no differences in researcher-selected frequency-modulated music and self-selected non-modulated music. The intervention consists of ten sessions of music listening in the course of three consecutive weeks.
Detailed description
This study aims to compare the impact of three different music listening interventions on stress and pain parameters. Participants will be assigned randomly to one of the conditions. In order to avoid expectancy-related effects, participants in both the researcher- and self-selected condition are told that they were allocated randomly to frequency-modulated or non-modulated music. Therefore, subjects are fully blinded with regards to frequency-modulation.
The study design is as follows:
- Baseline measurement: assessment of resting state biological parameters and questionnaires, CPT
- Music listening sessions: ten sessions in three consecutive weeks including:
- 60 minutes of music listening
- CPT following music listening (sessions 1, 3, 6, 10 only)
- Assessments: biological and subjective pain and stress parameters; music and mood related parameters
- Post measurement: assessment of resting state biological parameters and questionnaires, CPT
- Follow-up measurement: 4 weeks after intervention, assessment of resting state biological parameters and questionnaires, CPT
Participants respond to health-related questions (chronic stress, stress reactivity, sleep quality, fatigue, menstrual cycle phase) as well as mood and music-related questions at baseline, post-intervention, and follow-up which are assessed as potential outcome, moderator, and/or control variables. In addition, pain and stress parameters (both biological and subjective) are being assessed at baseline, post-intervention and follow-up as well as in the course of the ten music listening sessions. Furthermore, participants respond to specific music and mood related items following each music listening session (e.g. perceived valence, arousal, familiarity, liking, induced emotions, etc.).
It is hypothesized that listening to researcher-selected frequency-modulated music and self-selected non-modulated music results in stronger increases in pain tolerance and stronger decreases in pain intensity from baseline to post compared to listening to researcher-selected non-modulated music. Furthermore, stronger decreases in stress parameters (e.g. increases in HRV) from baseline to post are expected in the researcher-selected frequency-modulated music and self-selected non-modulated music than in the researcher-selected non-modulated music listening condition. Moreover, it is expected that there will be no differences in researcher-selected frequency-modulated music and self-selected non-modulated music with regards to pain and stress parameters. Additionally, it will be tested whether changes in pain parameters are being mediated* by changes in markers of stress-responsive systems (e.g. heart rate variability indices).
Finally, process analysis over the course of the music listening sessions sessions will be conducted with biological and subjective pain and stress indices as well as music and mood related parameters.
*Although checking for spelling mistakes before submitting the first record, a mistake in wording was discovered only after the release of the record and therefore corrected corresponding to our original hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| researcher-selected frequency-modulated music | Active comparator | Behavioral: researcher-selected frequency-modulated music |
| researcher-selected non-modulated music | Placebo comparator | Behavioral: researcher-selected non-modulated music |
| participant-selected non-modulated music | Experimental | Behavioral: participant-selected non-modulated music |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age: 18 - 35 years
- BMI: 18.5 - 30 kg/m²
- full command of the German language
- capability to attend ten sessions of music listening in our laboratory within three consecutive weeks, each for a duration of one hour
Key exclusion criteria (7 listed)
- music related profession or studies
- absolute hearing (self-report)
- physical conditions (self-report): tinnitus, hearing impairments, extreme visual impairment, cardiovascular diseases, diabetes, artery occlusive disease, hyper-/hypotension, Raynaud syndrome, chronic pain condition
- pregnancy, breastfeeding
- current mental disorders (self-report): major depression, anxiety disorder, eating disorder, substance dependence, psychosis, schizophrenia
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 |
|---|---|---|
| researcher-selected frequency-modulated musicMusic pieces have been selected in advance by the researchers. Furthermore, musical frequencies have been artificially modulated. | Behavioural | researcher-selected frequency-modulated music |
| researcher-selected non-modulated musicThe same music pieces as in the active comparator arm have been selected in advance by the researchers, but no artificial frequency modulation. | Behavioural | researcher-selected non-modulated music |
| participant-selected non-modulated musicParticipants bring their own choice of personally preferred music pieces and listen to them during the intervention sessions. There is no frequency modulation in this condition. | Behavioural | participant-selected non-modulated music |
Primary outcome
Pain Tolerance
Time frame: Pre-Post-Change-Design: change from baseline to after 3 weeks
Cold pressor test (CPT): Duration in seconds from immersion of one hand into cold water until removal of the hand: * baseline before music intervention * post assessment after completion of music intervention (3 weeks)
Pain Intensity
Time frame: Pre-Post-Change-Design: change from baseline to after 3 weeks
Cold pressor test (CPT): Subjective pain intensity of the test rated via visual analog scale at the time of removal of the hand * baseline assessment before music intervention * post assessment after completion of music intervention (3 weeks)
5 secondary outcomes
Subjective Stress Experience
Time frame: Pre-Post-Change-Design: change from baseline to after 3 weeks; process analysis during the course of the intervention
Subjective Stress Experience
Time frame: Pre-Post-Change-Design: change from baseline to after 3 weeks
Physiological Stress: Heart Rate Variability Indices
Time frame: Pre-Post-Change-Design: change from baseline to after 3 weeks, process analysis during the course of the intervention
Physiological Stress: Electrodermal activity (EDA)
Time frame: Pre-Post-Change-Design; change from baseline to after 3 weeks, process analysis during the course of the intervention
Physiological Stress: Hair Cortisol
Time frame: Pre-Post-Change-Design, change from baseline to 4 weeks after post assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 33329075Feneberg AC, Kappert MB, Maidhof RM, Doering BK, Olbrich D, Nater UM. Efficacy, Treatment Characteristics, and Biopsychological Mechanisms of Music-Listening Interventions in Reducing Pain (MINTREP): Study Protocol of a Three-Armed Pilot Randomized Controlled Trial. Front Psychiatry. 2020 Nov 4;11:518316. doi: 10.3389/fpsyt.2020.518316. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
Urs Nater, PhD principal investigator
University of Vienna
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing researcher-selected frequency-modulated music, researcher-selected non-modulated music and participant-selected non-modulated music in people with Pain Perception and Autonomic Nervous System Functioning, run by University of Vienna at 2 sites in 2 countries.
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 7 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. 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 Urs Nater, PhD (0043 - 1 - 4277 ext. 47220, urs.nater@univie.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Tolerance (time frame: Pre-Post-Change-Design: change from baseline to after 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02991014, which also lists 1 linked publication.
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 28 Apr 2021.