Three Brief Psychological Interventions for Acute Pain in Inpatients in Boyacá (NCT07254923)
🩺 Plain-English Summary (8th-Grade Level)
This study evaluates two brief, non-drug psychological techniques-body-scan mindfulness and guided imagery/distraction-delivered as a single bedside session to reduce acute pain in adults admitted to short-stay inpatient wards or emergency observation units in Boyacá, Colombia. Participants are randomly assigned (1:1:1) to body-scan mindfulness, guided imagery/distraction, or a brief cognitive-behavioral psychoeducation session (active comparator). Each session lasts under 20 minutes and usual medical care continues. Pain intensity (0-10) is recorded within 5 minutes before the session and within 2 minutes after completion on the same day. If pain remains very high (e.g., ≥8-9/10) or the activity cannot be completed, up to 5 minutes of supervised slow deep-breathing may be offered as rescue, and the clinical team may adjust analgesics per routine care. Secondary measures (specified in Outcome Measures) include patient satisfaction, feasibility (session duration and completion), use of rescue measure, and adverse events; exploratory data may include short-term psychological scales collected by a blinded assessor and the association with length of stay during the current admission. Adults aged ≥18 years with acute pain ≤7 days and baseline pain ≥4/10 may be eligible. The study takes place across four public hospitals in Boyacá, Colombia.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (8 items).
Location: ESE Hospital Regional de Chiquinquirá — Chiquinquirá, Departamento de Boyacá
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Cancer-related pain or chronic pain \>6 months (e.g., widespread musculoskeletal pain/fibromyalgia).
- Active inflammatory/degenerative rheumatic disease causing ongoing daily pain that would confound acute pain ratings (e.g., rheumatoid arthritis flare, advanced osteoarthritis, severe osteoporosis-related pain).
- Cognitive impairment/dementia, delirium, or acute severe psychiatric disturbance that prevents consent or reliable self-report.
- Respiratory conditions that contraindicate slow deep-breathing rescue (e.g., decompensated COPD, acute asthma, need for high-flow oxygen or ventilatory support).
- Hemodynamic or clinical instability (e.g., need for urgent procedure; in resuscitation/reanimation area; RASS ≤ -3; MAP \<65 mmHg or SBP \<90 mmHg; SpO₂ \<90% despite usual oxygen) at screening.
- Participation in another interventional study targeting pain during the same admission.
- Refusal to participate or withdrawal of consent.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- ESE Hospital Regional de Chiquinquirá — Chiquinquirá, Departamento de Boyacá
- ESE Hospital Santa Marta de Samacá — Samacá, Departamento de Boyacá
- ESE Hospital Regional de Sogamoso — Sogamoso, Departamento de Boyacá
- ESE Santiago de Tunja — Tunja, Departamento de Boyacá
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.