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

Music-based Intervention for the Reduction of Pain and Stress in Healthy Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Pain Perception; Autonomic Nervous System Functioning
• Intervention / Treatment: Behavioral: researcher-selected frequency-modulated music; Behavioral: researcher-selected non-modulated music; Behavioral: participant-selected non-modulated music

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Urs Nater, PhD; Phone Number: 47220 0043 - 1 - 4277; Email: urs.nater@univie.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1010
    • Recruiting
    • University of Vienna
    • Contact: Urs M Nater, PhD; Phone Number: 47220 +43-1-4277; Email: urs.nater@univie.ac.at
    • Principal Investigator: Rosa M Maidhof, MSc
• Germany
  • Hessen
    • Marburg, Hessen, Germany, 35037
      • Active, not recruiting
      • Philipps-University Marburg, Department of Psychology, Clinical Biopsychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Stress Experience	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)	Pre-Post-Change-Design: change from baseline to after 3 weeks; process analysis during the course of the intervention
Subjective Stress Experience	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)	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); resting state assessed at baseline and post after completion of music intervention; continuous assessment in each music listening session; assessment in response to CPT	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; resting state assessed at baseline and post after completion of music intervention; continuous assessment in each music listening session; assessment in response to CPT	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: baseline before music intervention; follow-up assessment 4 weeks after post assessment	Pre-Post-Change-Design, change from baseline to 4 weeks after post assessment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	MFI-20 (Multidimensional Fatigue Inventory); baseline before music intervention; post assessment after completion of music intervention (3 weeks)	Pre-Post-Change-Design; change from baseline to after 3 weeks
Sleep Quality	PSQI (Pittsburgh Sleep Quality Index)	Pre-Follow Up-Change-Design; change from baseline to 4 weeks after post assessment

Collaborators and Investigators

• Sponsor: University of Vienna

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (ESTIMATE): December 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: pain perception; heart rate variability; music intervention; frequency modulation; cold pressor test (CPT)
• Other Study ID Numbers: MINTREP-UN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED