Three Brief Psychological Interventions for Acute Pain in Inpatients in Boyacá

November 19, 2025 updated by: Andrés Felipe Calvo-Abaunza, Universidad Pedagógica y Tecnológica de Colombia

Three Brief Psychological Interventions for Acute Pain in Inpatients in Boyacá: Randomized Three-Arm Clinical 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a parallel-group, open-label, three-arm randomized trial (1:1:1) in short-stay inpatient wards and emergency observation units at four public hospitals in Boyacá, Colombia. The objective is to estimate the immediate effect of a single, brief bedside behavioral session on acute pain while routine medical care continues unchanged. Clinically stable adults provide written informed consent prior to any study procedures.

Participants are randomized to one of three groups. Group A (body-scan mindfulness) receives a guided practice that cultivates open, non-judgmental attention across body regions, including areas without pain, to modulate the nociceptive experience. Group B (guided imagery/distraction) receives a session using neutral/pleasant imagery and simple attentional shifts intended to redirect focus away from painful sensations. Group C (CBT-based psychoeducation; ABC model) serves as an active comparator and consists of a brief, structured explanation of the relationship between thoughts, emotions, and sensations using a practical example; no skills training is included. Each technique is delivered once (<20 minutes) by trained study personnel (e.g., psychology staff). The attending clinical team (physicians/nurses) is informed of participation and may adjust routine care as needed, but does not deliver study techniques or collect study outcomes. If post-session pain remains very high or a participant cannot complete the assigned activity, up to 5 minutes of supervised slow deep-breathing may be offered as a rescue measure; any analgesic adjustments are per routine care and are not protocol-driven.

Randomization uses a computer-generated sequence with variable permuted block sizes (1:1:1) prepared in advance and stored in a password-protected spreadsheet with locked sheets/cells and restricted access. Assignment is centralized: after eligibility confirmation, informed consent, and documentation of baseline pain, the enrolling clinician contacts the study coordinators, who control the file and release the next sequential assignment. Block sizes and the remaining sequence are concealed from enrolling staff; each release is time-stamped and logged to preserve allocation concealment and balanced assignment across arms.

Assessments follow standardized procedures. The primary endpoint is the immediate pre- to post-session change in pain intensity; operational details (instruments and exact time windows) are specified in Outcome Measures and captured on case-report forms. Where feasible, a blinded outcomes assessor administers only the post-session psychological scales 5-10 minutes after the session (e.g., PSEQ-10, PCS, HADS-A) and has no access to pain ratings or allocation files. Pain ratings and the participant satisfaction questionnaire are recorded at bedside by study personnel involved in the session. The pre-session length of stay during the index admission may also be abstracted from the medical record as specified in Outcome Measures.

The analysis overview is prespecified. The primary comparison of immediate pain change across arms will use a linear model under intention-to-treat, with post-session pain as the dependent variable and baseline pain and study site as covariates; adjusted mean differences with 95% confidence intervals will be reported. Secondary endpoints (e.g., safety and patient-reported satisfaction) will be summarized with models appropriate to their scale. Exploratory analyses will compare post-session psychological scale scores across arms and examine the association between pre-session length of stay and pain change. Missing post-session pain data are expected to be minimal; if present, prespecified sensitivity analyses (e.g., complete-case vs simple imputation) will be conducted. No multiplicity adjustment is planned for secondary/exploratory outcomes. Ethics approvals were obtained from the participating institutions; written informed consent is required prior to any study procedures.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Colombia
    • Departamento de Boyacá
      • Chiquinquirá, Departamento de Boyacá, Colombia, 154640
        • ESE Hospital Regional de Chiquinquirá
      • Samacá, Departamento de Boyacá, Colombia, 153660
        • ESE Hospital Santa Marta de Samacá
        • Contact:
        • Sub-Investigator:
          • Jhon F Buitrago, MG
      • Sogamoso, Departamento de Boyacá, Colombia, 152210
        • ESE Hospital Regional de Sogamoso
        • Contact:
        • Sub-Investigator:
          • Claudia Elena García Aragón, Mg
      • Tunja, Departamento de Boyacá, Colombia, 150001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).
  • Analgesic regimen stable ≥1 hour before baseline pain rating (no planned change during the ~20-minute study window unless clinically required).
  • Able to understand simple instructions and communicate pain ratings (verbal or pointing) and to provide written informed consent.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guided Imagery (B)
Single, bedside session (~15-20 min) of therapist-guided guided imagery that redirects attention from pain toward neutral or pleasant sensory images and simple attentional shifts. Delivered seated or semi-reclined in addition to usual care. Pain is rated immediately before and after the session (0-10). A protocolized slow deep-breathing rescue (≤5 min) may be offered if pain remains very high or the technique cannot be completed.
Behavioral: Guided Imagery
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).
Other Names:
  • Distraction
Experimental: Body-Scan Mindfulness (A)
Single, bedside body-scan mindfulness session (~12-20 min) guiding non-judgmental attention sequentially through body areas, including sites without pain, to foster an open, accepting stance toward the pain experience. Delivered seated or semi-reclined with usual care continuing. Pain is rated immediately before and after (0-10). Rescue slow deep-breathing (≤5 min) may be used if needed.
Behavioral: Body-Scan Mindfulness
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).
Other Names:
  • body scan
Active Comparator: CBT-Based Psychoeducation (ABC Model) (C)
Brief, structured explanation of the ABC cognitive-behavioral model applied to pain (~10-15 min) 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). Rescue slow deep-breathing (≤5 min) available per protocol.
Behavioral: CBT-Based Psychoeducation (ABC Model)
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).
Other Names:
  • ABC Model Education
  • Cognitive Behavioral Psychoeducation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in acute pain intensity (0-10 Pain Thermometer) from pre- to post-session
Time Frame: Two assessments on the same calendar day: ≤5 minutes before session start and ≤2 minutes after session end.
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).
Two assessments on the same calendar day: ≤5 minutes before session start and ≤2 minutes after session end.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with the session
Time Frame: One assessment ≤5 minutes after session end (same calendar day).
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).
One assessment ≤5 minutes after session end (same calendar day).
Participants requiring protocolized rescue slow deep-breathing
Time Frame: From session start until ≤10 minutes after session end (same calendar day).
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).
From session start until ≤10 minutes after session end (same calendar day).
Pain Self-Efficacy (PSEQ-10) - change from pre- to post-session
Time Frame: One assessment 5-10 minutes after session end (same calendar day).
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).
One assessment 5-10 minutes after session end (same calendar day).
Pain Catastrophizing (PCS) - change from pre- to post-session
Time Frame: One assessment 5-10 minutes after session end (same calendar day).
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.
One assessment 5-10 minutes after session end (same calendar day).
Hospital Anxiety (HADS-A) - change from pre-session to post-session
Time Frame: One assessment 5-10 minutes after session end (same calendar day).
7-item Hospital Anxiety subscale (0-21). Higher scores = more anxiety. Administered by a blinded outcomes assessor.
One assessment 5-10 minutes after session end (same calendar day).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days hospitalized immediately before the session (pre-session length of stay)
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Pedagógica y Tecnológica de Colombia

Collaborators

ESE Hospital Regional de Sogamoso
ESE Hospital Santa Marta de Samacá
ESE Santiago de Tunja
ESE Hospital Regional de Chiquinquirá

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 16, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT-PSI-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) underlying the primary outcome will be shared. Direct identifiers will be removed and indirect identifiers minimized in accordance with Colombian data protection law and IRB approvals.

IPD Sharing Time Frame

Within 12 months after publication of the primary results; available for 24 months thereafter.

IPD Sharing Access Criteria

Available upon reasonable request to the corresponding author/UPTC data custodian for qualified researchers with a methodologically sound proposal and ethics approval, after signing a Data Use Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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