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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| researcher-selected frequency-modulated music | Active Comparator |
| |
| researcher-selected non-modulated music | Placebo Comparator |
| |
| participant-selected non-modulated music | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| researcher-selected frequency-modulated music | Behavioral | Music pieces have been selected in advance by the researchers. Furthermore, musical frequencies have been artificially modulated. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Tolerance | Cold pressor test (CPT): Duration in seconds from immersion of one hand into cold water until removal of the hand:
| 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
| Pre-Post-Change-Design: change from baseline to after 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Stress Experience | visual analog scales
| Pre-Post-Change-Design: change from baseline to after 3 weeks; process analysis during the course of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | MFI-20 (Multidimensional Fatigue Inventory)
| Pre-Post-Change-Design; change from baseline to after 3 weeks |
| Sleep Quality |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Urs Nater, PhD | Contact | 0043 - 1 - 4277 | 47220 | urs.nater@univie.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Urs Nater, PhD | University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vienna | Recruiting | Vienna | 1010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33329075 | Derived | 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. |
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| researcher-selected non-modulated music | Behavioral | 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 | Behavioral | 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. |
|
| Subjective Stress Experience | Measurements:
| 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)
| 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
| 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:
| Pre-Post-Change-Design, change from baseline to 4 weeks after post assessment |
PSQI (Pittsburgh Sleep Quality Index)
| Pre-Follow Up-Change-Design; change from baseline to 4 weeks after post assessment |
| Philipps-University Marburg, Department of Psychology, Clinical Biopsychology | Active, not recruiting | Marburg | Hesse | 35037 | Germany |