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.
Chronic pain impacts nearly eight million Canadians, with many suffering from moderate to severe pain for over a decade. Traditional treatments often fail, prompting researchers to explore alternatives like intravenous (IV) ketamine infusions, initially developed as an anesthetic and now considered for conditions such as Complex Regional Pain Syndrome (CRPS) and fibromyalgia. Short-term benefits of ketamine for pain relief have been observed, but its long-term effects, optimal dosages, and safety profiles remain under investigation. Ketamine's psychedelic properties have shown potential in treating psychiatric conditions, suggesting it might alter patient's psychological outlook on their pain. This study aims to investigate the potential synergistic effects of IV ketamine infusions combined with self-selected music on chronic noncancer pain. A total of 25 patients from the Alan Edwards Pain Management Unit (AEPMU) will participate in a pragmatic randomized crossover controlled trial involving four ketamine infusion sessions, each lasting one hour with a dosage of 0.5 mg/kg. The sessions will include a baseline control session with treatment as usual, and three different conditions: self-selected music, therapist-selected music, and silence. All participants will undergo the same therapeutic procedures in a controlled environment, with noise-cancelling headphones and dim lighting, to standardize the experience. Participants will create personal music playlists lasting at least an hour, comprising songs that they find highly pleasurable and conducive to relaxation. Alternatively, they will be exposed to therapist-selected playlists designed specifically for psychedelic therapy or silence, ensuring a controlled setting with no background noise. The study will also require participants to engage with their music playlist or silence for one day each week, in a relaxed setting, to revisit their infusion experience. To assess the effects, both quantitative and qualitative data will be collected, including pain intensity, mood, sleep, cognitive flexibility, and symptoms of anxiety and depression. Participants will undergo semi-structured interviews one week post-infusion to evaluate patient benefits and any adverse effects of the ketamine and music interventions. This innovative approach seeks to enhance the understanding of how music can optimize the therapeutic potential of ketamine infusions, offering a novel avenue for managing chronic pain where conventional treatments have proven inadequate. The investigators anticipate that these findings will help optimize the use of IV ketamine at the AEPMU and in other settings where this treatment is available.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
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.
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.
Montreal General Hospital
Montreal, Quebec, Canada
RECRUITINGPain 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
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
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
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
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)
Brief Pain Inventory (number of pain sites)
The number of body sites in which participants report pain will be assessed using a body map with up to 30 potential body sites (Brief Pain Inventory).
Time frame: From baseline to the end of each condition (5 weeks)
Pain Catastrophizing Scale (PCS)
Pain catastrophizing thoughts and beliefs will be assessed using a 13-item questionnaire (PCS, score range 0 to 52)
Time frame: From baseline to the end of each condition (5 weeks)
Hospital Anxiety and Depression Scale (HADS)
Anxiety and depression symptoms will be assessed using a 14-item questionnaire (HADS, score range 0 to 42), with separate subscales for anxiety (HADS-A) and depression (HADS-D), each ranging from 0 to 21.
Time frame: From baseline to the end of each condition (5 weeks)
Positive and Negative Affect Scale (PANAS)
Positive and negative affect will be assessed using a 20-item questionnaire (PANAS, score range 20 to 100), with separate subscales for positive affect (PA) and negative affect (NA), each ranging from 10 to 50.
Time frame: From baseline to the end of each condition (5 weeks)
Multidimensional Psychological Flexibility Inventory (MPFI), short form
Cognitive and behavioral flexibility will be assessed using a 24-item questionnaire (MPFI-24, score range 24 to 120), with separate subscales for cognitive and behavioral flexibility, each ranging from 12 to 60.
Time frame: From baseline to the end of each condition (5 weeks)
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