Clinical trial NCT02991014: Music-based Intervention for the Reduction of Pain
Official title: Music-based Intervention for the Reduction of Pain and Stress in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Perception
Autonomic Nervous System Functioning
Keywords: music intervention
heart rate variability
frequency modulation
pain perception
cold pressor test (CPT)
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Pain Tolerance
timeFrame: Pre-Post-Change-Design: change from baseline to after 3 weeks
measure: Pain Intensity
timeFrame: Pre-Post-Change-Design: change from baseline to after 3 weeks
Secondary outcomes:
measure: Subjective Stress Experience
timeFrame: Pre-Post-Change-Design: change from baseline to after 3 weeks; process analysis during the course of the intervention
measure: Subjective Stress Experience
timeFrame: Pre-Post-Change-Design: change from baseline to after 3 weeks
measure: Physiological Stress: Heart Rate Variability Indices
timeFrame: Pre-Post-Change-Design: change from baseline to after 3 weeks, process analysis during the course of the intervention
measure: Physiological Stress: Electrodermal activity (EDA)
timeFrame: Pre-Post-Change-Design; change from baseline to after 3 weeks, process analysis during the course of the intervention
measure: Physiological Stress: Hair Cortisol
timeFrame: Pre-Post-Change-Design, change from baseline to 4 weeks after post assessment
Other outcomes:
measure: Fatigue
timeFrame: Pre-Post-Change-Design; change from baseline to after 3 weeks
measure: Sleep Quality
timeFrame: Pre-Follow Up-Change-Design; change from baseline to 4 weeks after post assessment
Locations:
city: Vienna
country: Austria
facility: University of Vienna
city: Marburg
country: Germany
facility: Philipps-University Marburg, Department of Psychology, Clinical Biopsychology
state: Hessen
Study officials:
affiliation: University of Vienna
name: Urs Nater, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.