Harmonized Healing: Personalized Music Interventions to Address Chronic Pain in People Living With HIV

Обзор

The goal of this randomized controlled trial is to understand the feasibility and acceptability of a music-based mobile application to address chronic pain in people with HIV. Participants in the intervention group will use the Harmonized Healing music app daily, or as needed, for 3 months. Participants in the control group will receive psychoeducation on chronic pain and strategies for pain management. All participants will attend monthly follow-up visits during the 3-month intervention period, and an additional follow-up visit at Month 6.

Подробное описание

Harmonized Healing is a novel, smartphone-driven, music-based behavioral intervention designed to help manage chronic pain in people with HIV. This two-arm pilot randomized controlled trial will enroll 60 individuals living with HIV and chronic pain. Participants will be randomized to receive either Harmonized Healing plus psychoeducation (intervention arm) or psychoeducation alone (control arm). Those in the intervention arm will be asked to use the Harmonized Healing music app daily, or as needed, for 3 months. Participants in both groups will attend monthly study visits during the 3-month intervention period, and one additional follow-up visit at Month 6.

The primary objective of this pilot study is to evaluate the feasibility and acceptability of the Harmonized Healing app. In addition, qualitative feedback will be collected from participants who used Harmonized Healing to better understand their experiences with the intervention and participation in the study.

Вмешательства

• Поведенческое Harmonized Healing App
  A smartphone-driven music-based intervention designed to support daily or as-needed use of personalized music to manage and alleviate pain exacerbations.
• Поведенческое Psychoeducation
  Educational materials on drivers of chronic pain in the context of HIV and strategies for pain management.

Первичные конечные точки

• Intervention Feasibility: Recruitment [Срок оценки: Month 3 Study Visits]
• Intervention Feasibility: Enrollment [Срок оценки: Month 3 Study Visits]
• Intervention Feasibility: Attrition [Срок оценки: Month 3 and Month 6 Study Visits]
• Intervention Feasibility: Adherence to Assessment Battery [Срок оценки: Month 3 and Month 6 Study Visits]
• Intervention Feasibility: FIM [Срок оценки: Month 3 Study Visit]
• Intervention Acceptability: Fidelity [Срок оценки: Month 3 Study Visit]
• Intervention Acceptability: Engagement (Percentage of days used) [Срок оценки: Month 3 Study Visit]
• Intervention Acceptability: Engagement (Minutes engaged per week) [Срок оценки: Month 3 Study Visit]
• Intervention Acceptability: AIM [Срок оценки: Month 3 Study Visit]
• Intervention Acceptability: Qualitative Exit Interviews [Срок оценки: Month 3 Study Visit]

Критерии участия

Критерии включения

• Adult ≥ 18 years old
• Owns a smartphone
• Living with HIV
• Currently prescribed antiretroviral therapy (ART) for HIV
• Experience with chronic pain (determined by self-reported pain of ≥3 on the Brief Pain Inventory for at least 3 months)

Критерии исключения

• Have a significant hearing loss
• HIV-negative
• Have been prescribed naltrexone

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07214077 · 2025P002274

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗