Health TrialsbyHealthPanel

Music as an Adjunct to Ketamine Therapy for Chronic Pain

ConditionsChronic PainChronic Noncancer Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcGill University

About this trial

Intravenous (IV) ketamine is a treatment option for patients with chronic pain that does not respond to standard therapies, primarily working by blocking NMDA receptors in the brain. Beyond pain relief, ketamine can produce dissociative sensations, classifying it as an atypical psychedelic or mind-altering drug, and may enable patients to reprocess their pain similarly to experiences with traditional psychedelics. At the Montreal General Hospital's pain clinic, the investigators have observed patients frequently listening to music during ketamine infusions, and recent research indicates that music-especially when self-selected by patients-might provide additional pain-relieving benefits by influencing central mechanisms related to pain perception and interpretation. This intersection of music and pain relief is garnering substantial scientific interest as recent advances provide more insight into the neuroscience of music and its effects on brain regions involved in emotion, sensation, memory, and pain.

This study aims to investigate the effects of music on chronic pain patients undergoing IV ketamine infusions at the Alan Edwards Pain Management Unit (AEPMU), specifically to determine whether the choice of music affects the intensity and duration of ketamine-induced pain relief. During the infusion (lasting 1 hour), patients will listen to a playlist delivered through specialized headphones, which will either consist of their own selected music (preferred music), music chosen by a music therapist, or no music at all, in a randomized order. Patients will track their pain levels throughout the infusion period and in the intervals between treatments (5 weeks) using standardized pain assessment tools. Additionally, the investigators will assess the subjective experiences of ketamine through interviews and qualitative analysis, while documenting and summarizing any adverse effects.

The investigators hypothesize that listening to preferred music will enhance both the intensity and duration of pain relief from IV ketamine. To test this, the investigators will recruit patients already receiving repeated IV ketamine infusions for pain management at the AEPMU clinic. The first infusion will take place under usual conditions to establish a baseline. The infusions will occur in a dedicated room equipped with audio technology to ensure an immersive music experience.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of chronic (3 months) pain of noncancerous origin, including chronic primary and secondary pain conditions, irrespective of its mechanistic contributors (nociceptive, neuropathic, or nociplastic), and of moderate to severe intensity (rated ≥ 4 in a 0-10 scale);

Participants must have been prescribed IV ketamine treatment at the AEPMU, based on their treating clinician's assessment and judgment;

Prior their participation in the study, all Participants must have undergone at least one ketamine IV session in the AEPMU clinical setting, which was well tolerated and did not reveal any important adverse effects, and which is expected to be repeated;

Be able to use an electronic device (e.g., computer, tablet, smartphone) to complete questionnaires and diaries. For patients who may not possess such a device, a smartphone will be loaned for the duration of the study;

Disqualifiers

Low tolerability or ineffectiveness of previous intravenous treatment or ketamine infusions;

Current diagnosis or treatment for cancer;

Significant hearing impairment not improved with hearing aids and/or sound amplification or unwillingness to listen to music during treatment;

Known intellectual disability or autism spectrum disorder;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Preferred Music

    Other intervention

    The self-selected preferred music intervention will expose participants to music chosen based on personal tastes. Patients will be instructed to compile a playlist lasting approximately 1 hour, but preferably over 1 hour (to avoid repetition or moments without music) of their favorite music. They will be instructed to select songs that they find extremely pleasurable to listen to. Participants will be instructed to select songs that will have a higher likelihood to facilitate relaxation and introspection. This does not need to be an all-time favorite selection, but rather the music that they currently enjoy listening to the most.

  • Therapist-selected Music

    Other intervention

    The therapist-selected music intervention will expose participants to a curated playlist specifically designed for psychedelic treatment by expert Music Therapists, which was used in a previous study to investigate the additive hemodynamic effects of music during ketamine infusions for depression. Patients will be randomly exposed to one of 9 available playlists, all containing songs without lyrics.

  • Silence

    Other intervention

    The silence intervention will expose patients to the same therapeutic procedures, in the same room and context, and with the same noise-cancelling headphones. The purpose is to cancel any potentially perturbing background noise, as no music will be played.

Treatment groups

25 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Preferred-Therapist-SilenceOther 3 interventions
Group B: Preferred-Silence-TherapistOther 3 interventions
Group C: Therapist-Preferred-SilenceOther 3 interventions
Group D: Therapist-Silence-PreferredOther 3 interventions
Group E: Silence-Therapist-PreferredOther 3 interventions
Group F: Silence-Preferred-TherapistOther 3 interventions

Trial outcomes

Primary outcomes

1

Pain intensity

Pain intensity assessed using a 0-10 visual rating scale anchored at 0 (absence of pain) and 10 (maximum pain imaginable). Participants will rate their average pain intensity in the previous 24 hours.

Time frame
From baseline to 24 hours after each ketamine session

Secondary outcomes

1

In-session Pain intensity

Pain intensity assessed using a 0-10 visual rating scale anchored at 0 (absence of pain) and 10 (maximum pain imaginable). Participants will rate their current pain intensity.

Time frame
Immediately before and after each ketamine session
2

In-session Pain unpleasantness

Pain unpleasantness assessed using a 0-10 visual rating scale anchored at 0 (absence of pain) and 10 (most unpleasant pain imaginable). Participants will rate their current pain intensity.

Time frame
Immediately before and after each ketamine session
3

Duration of pain relief

Duration of pain relief will be assessed based on repeated self-reported pain intensity ratings using a 0-10 visual rating scale, collected at multiple time points over a 5-week follow-up period. This outcome will capture how long participants experience sustained reductions in pain following each intervention condition.

Time frame
From baseline to the end of each condition (5 weeks) daily for one week, then weekly
4

Brief Pain Inventory (pain interference)

Pain interference will be assessed using an 7-item questionnaire (Brief Pain Inventory, score range 0 to 10 per item, 0 to 70 in total).

Time frame
From baseline to the end of each condition (5 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McGill University

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Source ClinicalTrials.gov
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