Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2016-12-31
2022-12-31
Brief Summary
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Detailed Description
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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:
1. 60 minutes of music listening
2. CPT following music listening (sessions 1, 3, 6, 10 only)
3. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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researcher-selected frequency-modulated music
researcher-selected frequency-modulated music
Music pieces have been selected in advance by the researchers. Furthermore, musical frequencies have been artificially modulated.
researcher-selected non-modulated music
researcher-selected non-modulated music
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 music
participant-selected non-modulated music
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.
Interventions
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researcher-selected frequency-modulated music
Music pieces have been selected in advance by the researchers. Furthermore, musical frequencies have been artificially modulated.
researcher-selected non-modulated music
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 music
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
35 Years
ALL
Yes
Sponsors
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University of Vienna
OTHER
Responsible Party
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Urs Nater
Prof. Dr.
Principal Investigators
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Urs Nater, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Vienna
Locations
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University of Vienna
Vienna, , Austria
Philipps-University Marburg, Department of Psychology, Clinical Biopsychology
Marburg, Hesse, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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MINTREP-UN
Identifier Type: -
Identifier Source: org_study_id
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