Three Brief Psychological Interventions for Acute Pain in Inpatients in Boyacá (NCT07254923)
Three Brief Psychological Interventions for Acute Pain in Inpatients in Boyacá: Randomized Three-Arm Clinical Trial
🩺 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: Review the eligibility criteria below.
Location: ESE Hospital Regional de Chiquinquirá — Chiquinquirá, Departamento de Boyacá
Age range: 18 Years to 90 Years
🧪 Interventions in This Study
- Guided Imagery (BEHAVIORAL)
- Body-Scan Mindfulness (BEHAVIORAL)
- CBT-Based Psychoeducation (ABC Model) (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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
📞 Contact the Study Coordinator
Phone: +573007795669
Email: andres.calvo@uptc.edu.co
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.