Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05726266
Status:
RECRUITING
Last Update Posted:
2023-07-06
First Post:
2023-01-25
Brief Title:
Effect and Safety of Listening to Music for Chronic Pain Relief
Sponsor:
Sebastian Videla
Organization:
Hospital Universitari de Bellvitge
Study Overview
Official Title:
Effect and Safety of Listening to Music or Audiobooks as a Coadjunvant Treatment for Chronic Pain Patients Under Opioid Treatment A Single-Center Open-Label Parallel Groups Controlled Randomized Pilot Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic pain is a multidimensional pathological condition that reduces patients quality of life and interferes with their daily family and work activities
Opioids are the most powerful analgesics in the treatment of pain They are used as a basic analgesic treatment for managing patients with chronic pain and as an analgesic treatment for managing breakthrough pain
Chronic administration of opioids can cause significant side effects eg dependence constipation and tolerance to their analgesic effects limiting their use Different behavioral therapies eg mindfulness and cognitive therapy have been proposed to potentiate the analgesic effects of opioids and consequently reduce the dose and the appearance of adverse effects One of the proposed approaches consists of listening to music therapeutically as a cognitive tool that modulates attention and regulates mood Some studies provide evidence that music can reduce opioid requirements in patients with chronic pain On the other hand both opioids and music activate brain circuits for reward reinforcement and motivation
Preliminary results obtained by our research group in animal models suggest that listening to music can reduce the appearance of a withdrawal syndrome after chronic administration of opioids
Our working hypothesis is that multimodal therapy based on listening to music as an adjuvant treatment to regular analgesic treatment with opioids reduces pain intensity and its harmful effects in patients diagnosed with chronic non-cancer pain Hence the daily amount of opioids taken will be reduced as well as the likelihood of developing opioid tolerance dependence and other opioid-related adverse events At the same time these patients emotional well-being and quality of life will improve
This is a parallel-group open-label single-center randomized pilot controlled clinical trial that aims to evaluate the effect and safety of music as a coadjuvant treatment for chronic non-cancer pain
Opioids are the most powerful analgesics in the treatment of pain They are used as a basic analgesic treatment for managing patients with chronic pain and as an analgesic treatment for managing breakthrough pain
Chronic administration of opioids can cause significant side effects eg dependence constipation and tolerance to their analgesic effects limiting their use Different behavioral therapies eg mindfulness and cognitive therapy have been proposed to potentiate the analgesic effects of opioids and consequently reduce the dose and the appearance of adverse effects One of the proposed approaches consists of listening to music therapeutically as a cognitive tool that modulates attention and regulates mood Some studies provide evidence that music can reduce opioid requirements in patients with chronic pain On the other hand both opioids and music activate brain circuits for reward reinforcement and motivation
Preliminary results obtained by our research group in animal models suggest that listening to music can reduce the appearance of a withdrawal syndrome after chronic administration of opioids
Our working hypothesis is that multimodal therapy based on listening to music as an adjuvant treatment to regular analgesic treatment with opioids reduces pain intensity and its harmful effects in patients diagnosed with chronic non-cancer pain Hence the daily amount of opioids taken will be reduced as well as the likelihood of developing opioid tolerance dependence and other opioid-related adverse events At the same time these patients emotional well-being and quality of life will improve
This is a parallel-group open-label single-center randomized pilot controlled clinical trial that aims to evaluate the effect and safety of music as a coadjuvant treatment for chronic non-cancer pain
Detailed Description:
Chronic non-cancer pain CNCP is defined as pain lasting from three to six months or persisting for longer than expected for tissue healing or underlying disease resolution López 2014 Other authors define it as pain lasting for more than three months continuously or intermittently present more than five days a week with moderate or high intensity on the visual analog scale VAS andor impairing ones functional capacity Guerra de Hoyos 2014
The World Health Organization WHO estimates that 20 of the world population suffers from chronic pain to some degree Turk 2011 Moreover CNCP impacts patients quality of life substantially affecting physical and psychosocial dimensions and interfering with daily-life activities It also poses a heavy burden on health and social security services by increasing healthcare and economic aid demand for lost days at work Breivik 2013 Zimmer 2021 Hopkins 2022
The main objective of the treatment is to maintain physical and mental functionality while improving quality of life This may require a multimodal approach including in addition to medication other interventions such as psychological therapy active physiotherapy movement therapy or percutaneous electrostimulation among others Turk 2011 However opioid use has been on the rise in the last few years and its use is not free from adverse events
Our working hypothesis is that a multimodal therapy based on listening to music as a coadjuvant treatment to maintenance analgesic treatment with opioids reduces pain intensity in patients diagnosed with CNCP As a result the daily amount of opioids taken will be reduced as well as the likelihood of developing opioid tolerance dependence and other opioid-related adverse events At the same time these patients emotional well-being and quality of life will improve
The World Health Organization WHO estimates that 20 of the world population suffers from chronic pain to some degree Turk 2011 Moreover CNCP impacts patients quality of life substantially affecting physical and psychosocial dimensions and interfering with daily-life activities It also poses a heavy burden on health and social security services by increasing healthcare and economic aid demand for lost days at work Breivik 2013 Zimmer 2021 Hopkins 2022
The main objective of the treatment is to maintain physical and mental functionality while improving quality of life This may require a multimodal approach including in addition to medication other interventions such as psychological therapy active physiotherapy movement therapy or percutaneous electrostimulation among others Turk 2011 However opioid use has been on the rise in the last few years and its use is not free from adverse events
Our working hypothesis is that a multimodal therapy based on listening to music as a coadjuvant treatment to maintenance analgesic treatment with opioids reduces pain intensity in patients diagnosed with CNCP As a result the daily amount of opioids taken will be reduced as well as the likelihood of developing opioid tolerance dependence and other opioid-related adverse events At the same time these patients emotional well-being and quality of life will improve
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None