Music-based Intervention for the Reduction of Pain — MINTREP  

Pain Perception Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autonomic Nervous System Functioning
• Pain Perception

• NCT number: NCT02991014
• Study type: Interventional
• Source: University of Vienna
• Contact: Urs Nater, PhD
• Phone: 0043 - 1 - 4277
• Email: urs.nater@univie.ac.at
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Completion date: December 2022