Three Brief Psychological Interventions for Acute Pain in Inpatients in Boyacá

ConditionsPain Management Pain Acute

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-90

SponsorUniversidad Pedagógica y Tecnológica de Colombia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Admitted to short-stay inpatient or emergency observation units at participating hospitals (same index admission).

Acute pain ≤7 days with baseline pain ≥4/10 on a 0-10 numeric/visual scale.

Clinically stable and able to remain at bedside for ~30-40 minutes (consent, baseline, single session, post-session assessment).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

Guided Imagery
Behavioral
Single, bedside session (\~15-20 minutes) of therapist-guided guided imagery/distraction that redirects attention from pain toward neutral or pleasant sensory images and simple attentional shifts. Seated or semi-reclined, conversational and supportive, in addition to usual care. Pain is rated immediately before and after the session (0-10).
Body-Scan Mindfulness
Behavioral
Single, bedside body-scan mindfulness session (\~12-20 minutes) guiding non-judgmental attention sequentially through body areas-including regions without pain-to cultivate an open, accepting stance toward pain. Delivered seated or semi-reclined with usual care continuing. Pain is rated immediately before and after (0-10).
CBT-Based Psychoeducation (ABC Model)
Behavioral
Brief, structured explanation of the ABC cognitive-behavioral model (thoughts-emotions-behaviors) applied to pain (\~10-15 minutes) using a practical example; no skills training or practice. Serves as an active comparator controlling for time and attention. After the immediate post-session pain assessment, participants in this arm receive one of the two techniques (body-scan mindfulness or guided imagery) during the same visit (equity measure).

Treatment groups

160 Participants

are divided into 3 treatment groups

Group A: Guided Imagery (B)Experimental treatment 1 intervention

Group B: Body-Scan Mindfulness (A)Experimental treatment 1 intervention

Group C: CBT-Based Psychoeducation (ABC Model) (C)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Change in acute pain intensity (0-10 Pain Thermometer) from pre- to post-session

Patient-reported Pain Thermometer adapted from VAS/NRS; 0 = no pain, 10 = worst imaginable pain. Higher scores indicate more pain. Change score = post-session minus pre-session (negative values indicate pain reduction).

Time frame

Two assessments on the same calendar day: ≤5 minutes before session start and ≤2 minutes after session end.

Secondary outcomes

Patient satisfaction with the session

Brief satisfaction questionnaire (two Likert items 1-10; higher scores = greater satisfaction). Open comments are collected but not scored. Report the mean satisfaction score (1-10).

Time frame

One assessment ≤5 minutes after session end (same calendar day).

Participants requiring protocolized rescue slow deep-breathing

Per protocol, up to 5 minutes of slow deep-breathing is offered if post-session pain is very high (e.g., ≥8/10) or the technique cannot be completed. Report the proportion of participants for whom rescue was used (Yes/No).

Time frame

From session start until ≤10 minutes after session end (same calendar day).

Pain Self-Efficacy (PSEQ-10) - change from pre- to post-session

PSEQ-10 (10 items, 0-6 each; total 0-60). Higher scores = greater pain self-efficacy. Administered and scored by a blinded outcomes assessor. Report change score (post minus pre).

Time frame

One assessment 5-10 minutes after session end (same calendar day).

Pain Catastrophizing (PCS) - change from pre- to post-session

Pain Catastrophizing Scale (PCS; 13 items, 0-4 per item; total 0-52). Subscales: Rumination, Magnification, Helplessness. Higher scores indicate greater catastrophizing. Administered and scored by a blinded outcomes assessor at a single post-session time point; intended to characterize cognitive-affective responses to pain during the index admission.

Time frame

One assessment 5-10 minutes after session end (same calendar day).

Other outcomes

Days hospitalized immediately before the session (pre-session length of stay)

Continuous days calculated as (session start - admission/observation start) ÷ 24 hours; same-day = 0.0 days; transfers use arrival to index hospital. Recorded to explore whether pre-session stay moderates the change in pain; it is not expected to be altered by the single session.

Time frame

Calculated on the day of the intervention, from index hospital admission/observation start to session start for the same hospitalization; assessed for admissions up to 30 days prior to the session.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Pedagógica y Tecnológica de Colombia

Lead sponsor

ESE Hospital Regional de Sogamoso

Collaborator

ESE Hospital Santa Marta de Samacá

Collaborator

ESE Santiago de Tunja

Collaborator

ESE Hospital Regional de Chiquinquirá

Collaborator

Source ClinicalTrials.gov

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