Music-based Intervention for the Reduction of Pain
MINTREP
1 other identifier
interventional
90
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 2, 2016
CompletedFirst Posted
Study publicly available on registry
December 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedApril 28, 2021
April 1, 2021
6 years
December 2, 2016
April 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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)
Pre-Post-Change-Design: change from baseline to after 3 weeks
Secondary Outcomes (5)
Subjective Stress Experience
Pre-Post-Change-Design: change from baseline to after 3 weeks; process analysis during the course of the intervention
Subjective Stress Experience
Pre-Post-Change-Design: change from baseline to after 3 weeks
Physiological Stress: Heart Rate Variability Indices
Pre-Post-Change-Design: change from baseline to after 3 weeks, process analysis during the course of the intervention
Physiological Stress: Electrodermal activity (EDA)
Pre-Post-Change-Design; change from baseline to after 3 weeks, process analysis during the course of the intervention
Physiological Stress: Hair Cortisol
Pre-Post-Change-Design, change from baseline to 4 weeks after post assessment
Other Outcomes (2)
Fatigue
Pre-Post-Change-Design; change from baseline to after 3 weeks
Sleep Quality
Pre-Follow Up-Change-Design; change from baseline to 4 weeks after post assessment
Study Arms (3)
researcher-selected frequency-modulated music
ACTIVE COMPARATORresearcher-selected non-modulated music
PLACEBO COMPARATORparticipant-selected non-modulated music
EXPERIMENTALInterventions
Music pieces have been selected in advance by the researchers. Furthermore, musical frequencies have been artificially modulated.
The same music pieces as in the active comparator arm have been selected in advance by the researchers, but no artificial frequency modulation.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Vienna
Vienna, 1010, Austria
Philipps-University Marburg, Department of Psychology, Clinical Biopsychology
Marburg, Hesse, 35037, Germany
Related Publications (1)
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.
PMID: 33329075DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Urs Nater, PhD
University of Vienna
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
December 2, 2016
First Posted
December 13, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
April 28, 2021
Record last verified: 2021-04