Chronic PainNCT05726266
Effect and Safety of Listening to Music for Chronic Pain Relief
A study testing Music and Audiobook in people with Chronic Pain, run by Víctor Fernández-Dueñas at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Music and Audiobook
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 18 May 2023to 16 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients with ≥18 years of age.
- Diagnosed with Chronic Non-Oncological Pain.
- Under regular (maintenance) opioid treatment for at least one month.
- Patients who sign the written informed consent.
Who cannot join
- Pregnant or lactating women.
- History of an organic brain disorder or substance abuse/dependence.
- History of Psychotic disorder, bipolar disorder, and/or intellectual disability.
- Patients at risk of opioid addiction.
- Patients that the Pain Clinic physician or psychologist believe will not comply with the study treatment/procedures.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
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
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.
Read more
Chronic administration of opioids can cause significant side effects (e.g., dependence, constipation) and tolerance to their analgesic effects, limiting their use. Different behavioral therapies (e.g., 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.
Read the 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), and/or impairing one's 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.
- Conditions
- Chronic Pain
- Being tested
- Music, Audiobook
- Keywords
- Music, Chronic Pain, Chronic Non-Cancer Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Patients will listen daily to a musical playlist for 30 - 60 minutes in a row; the psychologist will set up a music playlist according to the patient's individual interests. Patients will be asked to focus on this activity, that is, without performing any other activity simultaneously.
AudiobookOther
Patients will listen daily to an audiobook for 30 - 60 minutes in a row; the psychologist will set up a list of audiobooks according to the patient's individual interests. Patients will be asked to focus on this activity, that is, without performing any other activity simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| Music Group | Experimental | Patients randomized to this group will listen daily to a musical playlist for 30 - 60 minutes in a row through a mobile device. This will be performed in addition to the opioid treatment. Receives: Other: Music |
| Audiobooks Group | Placebo comparator | Patients randomized to this group will listen to an audiobook daily for 30 - 60 minutes in a row through a mobile device. This will be performed in addition to the opioid treatment. Receives: Other: Audiobook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by the Visual Analog Scale
The Visual Analog Scale is a continuous variable on a 10 cm line representing "no pain" (0 cm) to "worst imaginable pain" (10 cm).
Pain intensity was also prospectively assessed using an 11-point Numerical Rating Scale (NRS; 0-10), with higher scores indicating greater pain intensity.
We will consider as responders those patients with a ≥30% reduction in the "maximum pain intensity in the last 24 hours" at any time during the study compared to the baseline score (study start visit) for at least 3 consecutive days.
Measured: 4 weeks
Pain intensity differences from baseline during the 4 weeks of treatment
We will assess the mean pain intensity differences from baseline during the 4 weeks of treatment. Daily NRS pain-intensity differences from baseline.
Measured: 4 weeks
Scores on the Spanish Pain Questionnaire (SPQ)
The Spanish Pain Questionnaire (SPQ; Cuestionario Español del Dolor) is the Spanish adaptation of the Short-Form McGill Pain Questionnaire, with higher scores indicating greater pain intensity. Changes between the baseline and end-of-treatment scores will be assessed.
Measured: 4 weeks
Secondary outcomes (12)
Change in pain intensity considering alternative definitions of responder
Other definitions of responder will be considered for capturing different response nuances:
- Alternative Responder (AR) 1: ≥50% reduction in the "maximum pain intensity (MPI) in the last 24h" at any given time during the study compared to the baseline score for at least 3 consecutive days.
- AR2: ≥30% reduction in the "current pain" at any given time during the study compared to the baseline score for at least 3 consecutive days.
- AR3: ≥50% reduction in the "current pain" at any given time during the study compared to the baseline score for at least 3 consecutive days.
- AR4: ≥30% reduction in the "MPI in the last 24h" AND in the "current pain" at any given time during the study compared to the baseline score for at least 3 consecutive days.
- AR5: ≥50% reduction in the "MPI in the last 24h" AND in the "current pain" at any given time during the study compared to the baseline score for at least 3 consecutive days.
Measured: 4 weeks
Requirement of rescue analgesia
As an alternative way of measuring pain intensity. Therefore, we will consider another definition of responder:
- Alternative Responder 6: patients who do not require rescue analgesia.
Measured: 4 weeks
Change of status according to the Hospital Anxiety and Depression Scale (HADS) scores between the baseline and end-of-treatment visits.
The Hospital Anxiety and Depression Scale (HADS) is composed of 2 subscales, one for depression and the other for anxiety. Each subscale consists of 7 items; each item score ranges from 0 (best result possible) to 3 (worst result possible). A final subscale score is achieved by summing the items scores.
Scores in each subscale ranging from 0 to 7 denote normal levels of anxiety/depression; scores ranging from 8 - 10 denote borderline cases; scores ranging from 11 to 21 denote abnormal cases.
Measured: 4 weeks
Mean Total Mood Disturbance (TMD) scores (measured by the Profile of Mood States [POMS]) between the baseline and end-of-treatment visits.
The Profile of Mood States (POMS) questionnaire assesses six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. High vigor scores reflect a good mood or emotion, and low scores in the other subscales reflect a good mood or emotion. The total mood disturbance (TMD) score is computed by adding the five negative subscale scores (tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion) and subtracting the vigor score. Higher TMD scores indicate a greater degree of mood disturbance.
Measured: 4 weeks
Mean change in the Patient Global Impression of Change (PGIC) scores between the baseline and end-of-treatment visits.
The Patient Global Impression of Change (PGIC) is a self-reported 7-point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Measured: 4 weeks
Mean change in the Short-Form 36 (SF-36) scores between the baseline and end-of-treatment visits.
The Short-Form 36 (SF-36) consists of 36 questions meant to reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social function, emotional role, and mental health. Scores range from 0 (maximum disability) to 100 (no disability).
Measured: 4 weeks
Change in the EuroQoL - 5 Dimensions - 5 Levels (EQ-5D-5L) scores between the baseline and end-of-treatment visits.
The EuroQoL - 5 Dimensions - 5 Levels (EQ-5D-5L) comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: 4 weeks
Number of adverse events by treatment arm.
Overall number of AEs in each group
Measured: 4 weeks
Number of side effects derived from opioid use (UKU scale)
These will be assessed by the Udvalg für Kliniske Undersøgelser (UKU) Side Effect Rating Scale, a comprehensive rating scale that includes 48 individual side effects that can be grouped into the four main dimensions of psychic, neurological, autonomic and other side effects.
Measured: 4 weeks
Number of adverse events related to the treatments under study (music therapy or audiobooks).
Number of adverse events considered as treatment-emergent adverse events.
Measured: 4 weeks
Mean change in the Opioid Risk Tool (ORT) score
The Opioid Risk Tool (ORT) is a brief, self-report screening tool to assess the risk for opioid abuse among individuals prescribed opioids for treatment of chronic pain. Total scores of 3 or lower indicate low risk for future opioid abuse; 4 to 7 indicate moderate risk; and a score of 8 or higher indicate a high risk.
Measured: 4 weeks
Mean change in the Revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R) questionnaire score.
The Revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R) is a 24-question questionnaire created to help determine how much monitoring a patient on long-term opioid therapy might require. Questions are scored form 0 (best result) to 4 (worst result). A total score of 18 or higher is considered positive.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start18 May 2023
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Parallel groups
- Model description
- All included patients must be under regular (maintenance) opioid treatment for at least one month before randomization. Included patients will be randomized (1:1) either to the control (audiobooks) or to the experimental (music) group.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Víctor Fernández-Dueñas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Víctor Fernández-Dueñas, University of Barcelona
- Investigators
- Ancor S Alfonso, MD, Principal investigator, Anesthesiologist at Bellvitge University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726266
- Sponsor's protocol ID
- UB-FCL-MUSIC 2022
- Status last verified
- Oct 2026
- First submitted
- 25 Jan 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used or analyzed during the study will be available from the corresponding author on reasonable request.
Publications
Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet. 2011 Jun 25;377(9784):2226-35. doi: 10.1016/S0140-6736(11)60402-9.
PubMed 21704872Zimmer Z, Fraser K, Grol-Prokopczyk H, Zajacova A. A global study of pain prevalence across 52 countries: examining the role of country-level contextual factors. Pain. 2022 Sep 1;163(9):1740-1750. doi: 10.1097/j.pain.0000000000002557. Epub 2021 Dec 15.
PubMed 35027516Hopkins RE, Degenhardt L, Campbell G, Farnbach S, Gisev N. "Frustrated with the whole system": a qualitative framework analysis of the issues faced by people accessing health services for chronic pain. BMC Health Serv Res. 2022 Dec 31;22(1):1603. doi: 10.1186/s12913-022-08946-8.
PubMed 36587208Breivik H, Eisenberg E, O'Brien T; OPENMinds. The individual and societal burden of chronic pain in Europe: the case for strategic prioritisation and action to improve knowledge and availability of appropriate care. BMC Public Health. 2013 Dec 24;13:1229. doi: 10.1186/1471-2458-13-1229.
PubMed 24365383Grau-Sanchez J, Serrano A, Villoria J, Carnaval T, Porto MF, Zapata L, Flores-Garcia M, Segura E, Garrido-Pedrosa J, Rodriguez-Fornells A, Fernandez-Duenas V, Videla S. Effect and safety of listening to music or audiobooks as a coadjuvant treatment for chronic pain patients under opioid treatment: a study protocol for an open-label, parallel-group, randomised, controlled, proof-of-concept clinical trial in a tertiary hospital in the Barcelona South Metropolitan area. BMJ Open. 2023 Sep 11;13(9):e074948. doi: 10.1136/bmjopen-2023-074948.
PubMed 37696633
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05726266
- Acronym / sponsor ID
- UB-FCL-MUSIC 2022
- Conditions
- Chronic Pain
- Keywords
- Music, Chronic Pain, Chronic Non-Cancer Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Víctor Fernández-DueñasUniversity, hospital or other
- Study start
- 18 May 2023 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 13 Feb 2023 (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.
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 (e.g., dependence, constipation) and tolerance to their analgesic effects, limiting their use. Different behavioral therapies (e.g., 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), and/or impairing one's 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All included patients must be under regular (maintenance) opioid treatment for at least one month before randomization. Included patients will be randomized (1:1) either to the control (audiobooks) or to the experimental (music) group.
| Arm | Type | Receives |
|---|---|---|
| Music Group | Experimental | Other: MusicPatients randomized to this group will listen daily to a musical playlist for 30 - 60 minutes in a row through a mobile device. This will be performed in addition to the opioid treatment. |
| Audiobooks Group | Placebo comparator | Other: AudiobookPatients randomized to this group will listen to an audiobook daily for 30 - 60 minutes in a row through a mobile device. This will be performed in addition to the opioid treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with ≥18 years of age.
- Diagnosed with Chronic Non-Oncological Pain.
- Under regular (maintenance) opioid treatment for at least one month.
- Patients who sign the written informed consent.
Key exclusion criteria (5 listed)
- Pregnant or lactating women.
- History of an organic brain disorder or substance abuse/dependence.
- History of Psychotic disorder, bipolar disorder, and/or intellectual disability.
- Patients at risk of opioid addiction.
- Patients that the Pain Clinic physician or psychologist believe will not comply with the study treatment/procedures.
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 |
|---|---|---|
| MusicPatients will listen daily to a musical playlist for 30 - 60 minutes in a row; the psychologist will set up a music playlist according to the patient's individual interests. Patients will be asked to focus on this activity, that is, without performing any other activity simultaneously. | Other | Music Group |
| AudiobookPatients will listen daily to an audiobook for 30 - 60 minutes in a row; the psychologist will set up a list of audiobooks according to the patient's individual interests. Patients will be asked to focus on this activity, that is, without performing any other activity simultaneously. | Other | Audiobooks Group |
Primary outcome
Pain intensity measured by the Visual Analog Scale
Time frame: 4 weeks
The Visual Analog Scale is a continuous variable on a 10 cm line representing "no pain" (0 cm) to "worst imaginable pain" (10 cm). Pain intensity was also prospectively assessed using an 11-point Numerical Rating Scale (NRS; 0-10), with higher scores indicating greater pain intensity. We will consider as responders those patients with a ≥30% reduction in the "maximum pain intensity in the last 24 hours" at any time during the study compared to the baseline score (study start visit) for at least 3 consecutive days.
Pain intensity differences from baseline during the 4 weeks of treatment
Time frame: 4 weeks
We will assess the mean pain intensity differences from baseline during the 4 weeks of treatment. Daily NRS pain-intensity differences from baseline.
Scores on the Spanish Pain Questionnaire (SPQ)
Time frame: 4 weeks
The Spanish Pain Questionnaire (SPQ; Cuestionario Español del Dolor) is the Spanish adaptation of the Short-Form McGill Pain Questionnaire, with higher scores indicating greater pain intensity. Changes between the baseline and end-of-treatment scores will be assessed.
12 secondary outcomes
Change in pain intensity considering alternative definitions of responder
Time frame: 4 weeks
Requirement of rescue analgesia
Time frame: 4 weeks
Change of status according to the Hospital Anxiety and Depression Scale (HADS) scores between the baseline and end-of-treatment visits.
Time frame: 4 weeks
Mean Total Mood Disturbance (TMD) scores (measured by the Profile of Mood States [POMS]) between the baseline and end-of-treatment visits.
Time frame: 4 weeks
Mean change in the Patient Global Impression of Change (PGIC) scores between the baseline and end-of-treatment visits.
Time frame: 4 weeks
Mean change in the Short-Form 36 (SF-36) scores between the baseline and end-of-treatment visits.
Time frame: 4 weeks
Change in the EuroQoL - 5 Dimensions - 5 Levels (EQ-5D-5L) scores between the baseline and end-of-treatment visits.
Time frame: 4 weeks
Number of adverse events by treatment arm.
Time frame: 4 weeks
Number of side effects derived from opioid use (UKU scale)
Time frame: 4 weeks
Number of adverse events related to the treatments under study (music therapy or audiobooks).
Time frame: 4 weeks
Mean change in the Opioid Risk Tool (ORT) score
Time frame: 4 weeks
Mean change in the Revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R) questionnaire score.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 21704872Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet. 2011 Jun 25;377(9784):2226-35. doi: 10.1016/S0140-6736(11)60402-9.
- Background: PubMed 35027516Zimmer Z, Fraser K, Grol-Prokopczyk H, Zajacova A. A global study of pain prevalence across 52 countries: examining the role of country-level contextual factors. Pain. 2022 Sep 1;163(9):1740-1750. doi: 10.1097/j.pain.0000000000002557. Epub 2021 Dec 15.
- Background: PubMed 36587208Hopkins RE, Degenhardt L, Campbell G, Farnbach S, Gisev N. "Frustrated with the whole system": a qualitative framework analysis of the issues faced by people accessing health services for chronic pain. BMC Health Serv Res. 2022 Dec 31;22(1):1603. doi: 10.1186/s12913-022-08946-8.
- Background: PubMed 24365383Breivik H, Eisenberg E, O'Brien T; OPENMinds. The individual and societal burden of chronic pain in Europe: the case for strategic prioritisation and action to improve knowledge and availability of appropriate care. BMC Public Health. 2013 Dec 24;13:1229. doi: 10.1186/1471-2458-13-1229.
- Derived from this study: PubMed 37696633Grau-Sanchez J, Serrano A, Villoria J, Carnaval T, Porto MF, Zapata L, Flores-Garcia M, Segura E, Garrido-Pedrosa J, Rodriguez-Fornells A, Fernandez-Duenas V, Videla S. Effect and safety of listening to music or audiobooks as a coadjuvant treatment for chronic pain patients under opioid treatment: a study protocol for an open-label, parallel-group, randomised, controlled, proof-of-concept clinical trial in a tertiary hospital in the Barcelona South Metropolitan area. BMJ Open. 2023 Sep 11;13(9):e074948. doi: 10.1136/bmjopen-2023-074948.
- Guerra de Hoyos, 2014Link provided by the sponsor.
- López, 2014Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The datasets used or analyzed during the study will be available from the corresponding author on reasonable request.
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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. This study is not recruiting at the moment.
Ancor S Alfonso, MD principal investigator
Anesthesiologist at Bellvitge University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and Audiobook in people with Chronic Pain, run by Víctor Fernández-Dueñas at 1 site in Spain.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 16 Oct 2026. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured by the Visual Analog Scale (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 NCT05726266, which also lists 5 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 16 Oct 2026.