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Music-based Intervention for the Reduction of Pain (MINTREP)

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ClinicalTrials.gov Identifier: NCT02991014
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Urs Nater, University of Vienna

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Pain Perception Autonomic Nervous System Functioning Behavioral: researcher-selected frequency-modulated music Behavioral: researcher-selected non-modulated music Behavioral: participant-selected non-modulated music Not Applicable

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:

    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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Music-based Intervention for the Reduction of Pain and Stress in Healthy Adults
Study Start Date : December 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Active Comparator: researcher-selected frequency-modulated music Behavioral: researcher-selected frequency-modulated music
Music pieces have been selected in advance by the researchers. Furthermore, musical frequencies have been artificially modulated.

Placebo Comparator: researcher-selected non-modulated music Behavioral: 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.

Experimental: participant-selected non-modulated music Behavioral: 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.




Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. Subjective Stress Experience [ Time Frame: Pre-Post-Change-Design: change from baseline to after 3 weeks; process analysis during the course of the intervention ]

    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)

  2. Subjective Stress Experience [ Time Frame: Pre-Post-Change-Design: change from baseline to after 3 weeks ]

    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)

  3. 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 ]

    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

  4. 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 ]

    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

  5. Physiological Stress: Hair Cortisol [ Time Frame: Pre-Post-Change-Design, change from baseline to 4 weeks after post assessment ]

    Hair Cortisol assessment:

    • baseline before music intervention
    • follow-up assessment 4 weeks after post assessment


Other Outcome Measures:
  1. Fatigue [ Time Frame: Pre-Post-Change-Design; change from baseline to after 3 weeks ]

    MFI-20 (Multidimensional Fatigue Inventory)

    • baseline before music intervention
    • post assessment after completion of music intervention (3 weeks)

  2. Sleep Quality [ Time Frame: Pre-Follow Up-Change-Design; change from baseline to 4 weeks after post assessment ]
    PSQI (Pittsburgh Sleep Quality Index)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991014


Contacts
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Contact: Urs Nater, PhD 0043 - 1 - 4277 ext 47220 urs.nater@univie.ac.at

Locations
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Austria
University of Vienna Recruiting
Vienna, Austria, 1010
Contact: Urs M Nater, PhD    +43-1-4277 ext 47220    urs.nater@univie.ac.at   
Sub-Investigator: Anja C Feneberg, MSc         
Principal Investigator: Rosa M Maidhof, MSc         
Germany
Philipps-University Marburg, Department of Psychology, Clinical Biopsychology Active, not recruiting
Marburg, Hessen, Germany, 35037
Sponsors and Collaborators
University of Vienna
Investigators
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Principal Investigator: Urs Nater, PhD University of Vienna
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Responsible Party: Urs Nater, Prof. Dr., University of Vienna
ClinicalTrials.gov Identifier: NCT02991014    
Other Study ID Numbers: MINTREP-UN
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Urs Nater, University of Vienna:
music intervention
heart rate variability
frequency modulation
pain perception
cold pressor test (CPT)