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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Spain

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 groups in NCT05726266
Study groupRoleWhat they receive
Music GroupExperimentalPatients 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 GroupPlacebo comparatorPatients 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Number of adverse events by treatment arm.

    Overall number of AEs in each group

    Measured: 4 weeks

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted13 Feb 2023
  2. Study start18 May 2023
  3. Primary completion16 Oct 2025
  4. Study completion16 Oct 2025

Resources

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)
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 21704872
  • Zimmer 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 35027516
  • Hopkins 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 36587208
  • Breivik 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 24365383
  • Grau-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

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.

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