Effect and Safety of Listening to Music for Chronic Pain Relief

NCT05726266 | Unknown

• 1 other identifier: UB-FCL-MUSIC 2022
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Chronic Pain

Keywords

Music; Chronic Pain; Chronic Non-Cancer Pain

Outcome Measures

Primary Outcomes (3)

• 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). 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.

  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. These mean pain intensity differences will be used to obtain the sum of pain intensity differences (by calculating the area under the time-analgesic effect curve).

  4 weeks

• Scores on the McGill Multidimensional Pain Questionnaire

  The McGill Multidimensional Pain Questionnaire scores range from 0 (No Pain) to 78 (Severe Pain). Changes between the baseline and end-of-treatment scores will be assessed.

  4 weeks

Secondary Outcomes (12)

• Change in pain intensity considering alternative definitions of responder (also measured by the Visual Analog Scale)

  4 weeks

• Requirement of rescue analgesia

  4 weeks

• Change of status according to the Hospital Anxiety and Depression Scale (HADS) scores between the baseline and end-of-treatment visits.

  4 weeks

• Mean Total Mood Disturbance (TMD) scores (measured by the Profile of Mood States [POMS]) between the baseline and end-of-treatment visits.

  4 weeks

• Mean change in the Patient Global Impression of Change (PGIC) scores between the baseline and end-of-treatment visits.

  4 weeks

Study Arms (2)

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.

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.

Other: Audiobook

Interventions

Music OTHER

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.

Music Group

Audiobook OTHER

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.

Audiobooks Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sebastian Videla: lead

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 21704872 BACKGROUND

• 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.

  PMID: 35027516 BACKGROUND

• 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.

  PMID: 36587208 BACKGROUND

• 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.

  PMID: 24365383 BACKGROUND

• 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.

  PMID: 37696633 DERIVED

Related Links

• Guerra de Hoyos, 2014
• López, 2014

MeSH Terms

Conditions

Chronic Pain

Interventions

Music Therapy; Sound Recordings

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Ancor S Alfonso, MD

  Anesthesiologist at Bellvitge University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian V Ces, MD, PhD

CONTACT

034932607625; svidela@bellvitgehospital.cat

Víctor F Dueñas, PhD

CONTACT

034934024280; vfernandez@ub.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Clinical Research Support Unit

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 13, 2023
• Study Start: May 18, 2023
• Primary Completion: September 1, 2024
• Study Completion: May 1, 2025
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)