Chronic PainMusKiPNCT06994559
Music as an Adjunct to Ketamine Therapy for Chronic Pain
A study testing Preferred Music, Therapist-selected Music and Silence in people with Chronic Pain and Chronic Noncancer Pain, run by McGill University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Chronic Noncancer Pain
- What is being tested?
- Preferred Music, Therapist-selected Music and Silence
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2025to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- No contraindication for intravenous ketamine treatment, including: poorly controlled cardiovascular disease, pregnancy or current or past history of psychosis, moderate to severe hepatic disease, elevated intracranial or extraocular pressure, and current or past history of substance abuse;
- Abstention from consuming grapefruit juice on the day of the ketamine infusions as it may alter the metabolism of ketamine;
Who cannot join
- 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;
- Known risk factors for intracranial hemorrhage, including previous significant trauma, known aneurysm, or previous neurosurgery;
- Evidence of clinically relevant disease, e.g., renal or hepatic impairment, significant coronary artery disease (myocardial infarct within a year prior to initial randomization), cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome or history of seizure disorder;
- Prior or current (i.e., past-year) history of substance use disorder (except for caffeine or nicotine use disorder) as defined by DSM-5 criteria;
- Acute psychotic or suicidal ideation symptoms, as judged by the referring clinician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carlos Gevers-Montoro, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Mark A Ware, MD, +1-5149348222, mark.ware@mcgill.ca
About this study
Official title: Investigating the Synergistic Potential of Music as an Adjunct to Ketamine Therapy for Chronic Noncancer Pain
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.
Read the detailed description
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.
- Conditions
- Chronic Pain, Chronic Noncancer Pain
- Being tested
- Preferred Music, Therapist-selected Music, Silence
- Keywords
- Chronic pain, Ketamine, Music
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preferred MusicOther
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 MusicOther
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.
SilenceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Preferred-Therapist-Silence | Other | Participants in this arm will be exposed to 1) Preferred music, 2) Therapist-selected music and 3) Silence in this order Receives: Other: Preferred Music; Other: Therapist-selected Music; Other: Silence |
| Preferred-Silence-Therapist | Other | Participants in this arm will be exposed to 1) Preferred music, 2) Silence, and 3) Therapist-selected music, in this order Receives: Other: Preferred Music; Other: Therapist-selected Music; Other: Silence |
| Therapist-Preferred-Silence | Other | Participants in this arm will be exposed to 1) Therapist-selected music, 2) Preferred music, 3) Silence, in this order Receives: Other: Preferred Music; Other: Therapist-selected Music; Other: Silence |
| Therapist-Silence-Preferred | Other | Participants in this arm will be exposed to 1) Therapist-selected music, 2) Silence, and 3) Preferred music, in this order Receives: Other: Preferred Music; Other: Therapist-selected Music; Other: Silence |
| Silence-Therapist-Preferred | Other | Participants in this arm will be exposed to 1) Silence, 2) Therapist-selected music, and 3) Preferred music, in this order Receives: Other: Preferred Music; Other: Therapist-selected Music; Other: Silence |
| Silence-Preferred-Therapist | Other | Participants in this arm will be exposed to 1) Silence, 2) Preferred music, and 3) Therapist-selected music, in this order Receives: Other: Preferred Music; Other: Therapist-selected Music; Other: Silence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 24 hours after each ketamine session
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to the end of each condition (5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jun 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Mathieu Roy, McGill University
- Investigators
- Mark A Ware, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreMathieu Roy, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994559
- Sponsor's protocol ID
- Music-Ketamine
- Acronym
- MusKiP
- Status last verified
- Jun 2025
- First submitted
- 20 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be share upon reasonable request
Publications
Sorensen J, Bengtsson A, Backman E, Henriksson KG, Bengtsson M. Pain analysis in patients with fibromyalgia. Effects of intravenous morphine, lidocaine, and ketamine. Scand J Rheumatol. 1995;24(6):360-5. doi: 10.3109/03009749509095181.
PubMed 8610220Olofsen E, Kamp J, Henthorn TK, van Velzen M, Niesters M, Sarton E, Dahan A. Ketamine Psychedelic and Antinociceptive Effects Are Connected. Anesthesiology. 2022 May 1;136(5):792-801. doi: 10.1097/ALN.0000000000004176.
PubMed 35188952Lunde SJ, Vuust P, Garza-Villarreal EA, Vase L. Music-induced analgesia: how does music relieve pain? Pain. 2019 May;160(5):989-993. doi: 10.1097/j.pain.0000000000001452. No abstract available.
PubMed 30507782Greenway KT, Garel N, Goyette N, Turecki G, Richard-Devantoy S. Adjunctive music improves the tolerability of intravenous ketamine for bipolar depression. Int Clin Psychopharmacol. 2021 Jul 1;36(4):218-220. doi: 10.1097/YIC.0000000000000363.
PubMed 33902087Greenway KT, Garel N, Dinh-Williams LL, Beaulieu S, Turecki G, Rej S, Richard-Devantoy S. Music as an Intervention to Improve the Hemodynamic Response of Ketamine in Depression: A Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2354719. doi: 10.1001/jamanetworkopen.2023.54719.
PubMed 38315489Garza-Villarreal EA, Pando V, Vuust P, Parsons C. Music-Induced Analgesia in Chronic Pain Conditions: A Systematic Review and Meta-Analysis. Pain Physician. 2017 Nov;20(7):597-610.
PubMed 29149141
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Synergistic Potential of Music as an Adjunct to Ketamine Therapy for Chronic Noncancer Pain
- ClinicalTrials.gov ID
- NCT06994559
- Acronym / sponsor ID
- MusKiP / Music-Ketamine
- Conditions
- Chronic Pain, Chronic Noncancer Pain
- Keywords
- Chronic pain, Ketamine, Music
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Preferred-Therapist-Silence | Other | Other: Preferred Music, Other: Therapist-selected Music, Other: SilenceParticipants in this arm will be exposed to 1) Preferred music, 2) Therapist-selected music and 3) Silence in this order |
| Preferred-Silence-Therapist | Other | Other: Preferred Music, Other: Therapist-selected Music, Other: SilenceParticipants in this arm will be exposed to 1) Preferred music, 2) Silence, and 3) Therapist-selected music, in this order |
| Therapist-Preferred-Silence | Other | Other: Preferred Music, Other: Therapist-selected Music, Other: SilenceParticipants in this arm will be exposed to 1) Therapist-selected music, 2) Preferred music, 3) Silence, in this order |
| Therapist-Silence-Preferred | Other | Other: Preferred Music, Other: Therapist-selected Music, Other: SilenceParticipants in this arm will be exposed to 1) Therapist-selected music, 2) Silence, and 3) Preferred music, in this order |
| Silence-Therapist-Preferred | Other | Other: Preferred Music, Other: Therapist-selected Music, Other: SilenceParticipants in this arm will be exposed to 1) Silence, 2) Therapist-selected music, and 3) Preferred music, in this order |
| Silence-Preferred-Therapist | Other | Other: Preferred Music, Other: Therapist-selected Music, Other: SilenceParticipants in this arm will be exposed to 1) Silence, 2) Preferred music, and 3) Therapist-selected music, in this order |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- No contraindication for intravenous ketamine treatment, including: poorly controlled cardiovascular disease, pregnancy or current or past history of psychosis, moderate to severe hepatic disease, elevated intracranial or extraocular pressure, and current or past history of substance abuse;
Key exclusion criteria (8 listed)
- 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;
- Known risk factors for intracranial hemorrhage, including previous significant trauma, known aneurysm, or previous neurosurgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preferred MusicThe 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. | Other | Preferred-Silence-Therapist, Preferred-Therapist-Silence, Silence-Preferred-Therapist, Silence-Therapist-Preferred, Therapist-Preferred-Silence, Therapist-Silence-Preferred |
| Therapist-selected MusicThe 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. | Other | Preferred-Silence-Therapist, Preferred-Therapist-Silence, Silence-Preferred-Therapist, Silence-Therapist-Preferred, Therapist-Preferred-Silence, Therapist-Silence-Preferred |
| SilenceThe 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. | Other | Preferred-Silence-Therapist, Preferred-Therapist-Silence, Silence-Preferred-Therapist, Silence-Therapist-Preferred, Therapist-Preferred-Silence, Therapist-Silence-Preferred |
Primary outcome
Pain intensity
Time frame: From baseline to 24 hours after each ketamine session
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.
9 secondary outcomes
In-session Pain intensity
Time frame: Immediately before and after each ketamine session
In-session Pain unpleasantness
Time frame: Immediately before and after each ketamine session
Duration of pain relief
Time frame: From baseline to the end of each condition (5 weeks) daily for one week, then weekly
Brief Pain Inventory (pain interference)
Time frame: From baseline to the end of each condition (5 weeks)
Brief Pain Inventory (number of pain sites)
Time frame: From baseline to the end of each condition (5 weeks)
Pain Catastrophizing Scale (PCS)
Time frame: From baseline to the end of each condition (5 weeks)
Hospital Anxiety and Depression Scale (HADS)
Time frame: From baseline to the end of each condition (5 weeks)
Positive and Negative Affect Scale (PANAS)
Time frame: From baseline to the end of each condition (5 weeks)
Multidimensional Psychological Flexibility Inventory (MPFI), short form
Time frame: From baseline to the end of each condition (5 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Background: PubMed 8610220Sorensen J, Bengtsson A, Backman E, Henriksson KG, Bengtsson M. Pain analysis in patients with fibromyalgia. Effects of intravenous morphine, lidocaine, and ketamine. Scand J Rheumatol. 1995;24(6):360-5. doi: 10.3109/03009749509095181.
- Background: PubMed 35188952Olofsen E, Kamp J, Henthorn TK, van Velzen M, Niesters M, Sarton E, Dahan A. Ketamine Psychedelic and Antinociceptive Effects Are Connected. Anesthesiology. 2022 May 1;136(5):792-801. doi: 10.1097/ALN.0000000000004176.
- Background: PubMed 30507782Lunde SJ, Vuust P, Garza-Villarreal EA, Vase L. Music-induced analgesia: how does music relieve pain? Pain. 2019 May;160(5):989-993. doi: 10.1097/j.pain.0000000000001452. No abstract available.
- Background: PubMed 33902087Greenway KT, Garel N, Goyette N, Turecki G, Richard-Devantoy S. Adjunctive music improves the tolerability of intravenous ketamine for bipolar depression. Int Clin Psychopharmacol. 2021 Jul 1;36(4):218-220. doi: 10.1097/YIC.0000000000000363.
- Background: PubMed 38315489Greenway KT, Garel N, Dinh-Williams LL, Beaulieu S, Turecki G, Rej S, Richard-Devantoy S. Music as an Intervention to Improve the Hemodynamic Response of Ketamine in Depression: A Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2354719. doi: 10.1001/jamanetworkopen.2023.54719.
- Background: PubMed 29149141Garza-Villarreal EA, Pando V, Vuust P, Parsons C. Music-Induced Analgesia in Chronic Pain Conditions: A Systematic Review and Meta-Analysis. Pain Physician. 2017 Nov;20(7):597-610.
- Individual participant dataSharing planned: Yes. IPD will be share upon reasonable request
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Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Gevers-Montoro, PhD contact
Mark A Ware, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Mathieu Roy, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preferred Music, Therapist-selected Music and Silence in people with Chronic Pain and Chronic Noncancer Pain, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark A Ware, MD (1-5149348222, mark.ware@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: From baseline to 24 hours after each ketamine session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06994559, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.