Three Brief Psychological Interventions for Acute Pain in Inpatients in Boyacá

NCT07254923 | Not Yet Recruiting

• 1 other identifier: RCT-PSI-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Pain Management; Pain Acute

Keywords

body scanning; ABC; Guided Imagery; Breathing Exercises; Acute Pain; Pain Measurement; Pain Management; Inpatients; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (5)

• Patient satisfaction with the session

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

• Participants requiring protocolized rescue slow deep-breathing

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

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

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

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

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

• Hospital Anxiety (HADS-A) - change from pre-session to post-session

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

Other Outcomes (1)

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

  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.

Study Arms (3)

Guided Imagery (B)

EXPERIMENTAL

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

Body-Scan Mindfulness (A)

EXPERIMENTAL

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

CBT-Based Psychoeducation (ABC Model) (C)

ACTIVE COMPARATOR

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)

Interventions

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).

Also known as: Distraction

Guided Imagery (B)

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).

Also known as: body scan

Body-Scan Mindfulness (A)

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).

Also known as: ABC Model Education, Cognitive Behavioral Psychoeducation

CBT-Based Psychoeducation (ABC Model) (C)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Pedagógica y Tecnológica de Colombia: lead
• ESE Hospital Regional de Sogamoso: collaborator
• ESE Hospital Santa Marta de Samacá: collaborator
• ESE Santiago de Tunja: collaborator
• ESE Hospital Regional de Chiquinquirá: collaborator

Study Sites (4)

ESE Hospital Regional de Chiquinquirá

Chiquinquirá, Departamento de Boyacá, 154640, Colombia

Location

ESE Hospital Santa Marta de Samacá

Samacá, Departamento de Boyacá, 153660, Colombia

Location

ESE Hospital Regional de Sogamoso

Sogamoso, Departamento de Boyacá, 152210, Colombia

Location

ESE Santiago de Tunja

Tunja, Departamento de Boyacá, 150001, Colombia

Location

Related Publications (12)

• Sun JN, Chen W, Zhang Y, Zhang Y, Feng S, Chen XY. Does cognitive behavioral education reduce pain and improve joint function in patients after total knee arthroplasty? A randomized controlled trial. Int Orthop. 2020 Oct;44(10):2027-2035. doi: 10.1007/s00264-020-04767-8. Epub 2020 Aug 8.

  PMID: 32772319 BACKGROUND

• Miller-Matero LR, Coleman JP, Smith-Mason CE, Moore DA, Marszalek D, Ahmedani BK. A Brief Mindfulness Intervention for Medically Hospitalized Patients with Acute Pain: A Pilot Randomized Clinical Trial. Pain Med. 2019 Nov 1;20(11):2149-2154. doi: 10.1093/pm/pnz082.

  PMID: 31329961 BACKGROUND

• Maniaci G, Daino M, Iapichino M, Giammanco A, Taormina C, Bonura G, Sardella Z, Carolla G, Cammareri P, Sberna E, Clesi MF, Ferraro L, Gambino CM, Ciaccio M, Rispoli L, La Cascia C, La Barbera D, Quattrone D. Neurobiological and Anti-Inflammatory Effects of a Deep Diaphragmatic Breathing Technique Based on Neofunctional Psychotherapy: A Pilot RCT. Stress Health. 2024 Dec;40(6):e3503. doi: 10.1002/smi.3503. Epub 2024 Nov 14.

  PMID: 39543797 BACKGROUND

• Joseph AE, Moman RN, Barman RA, Kleppel DJ, Eberhart ND, Gerberi DJ, Murad MH, Hooten WM. Effects of Slow Deep Breathing on Acute Clinical Pain in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Evid Based Integr Med. 2022 Jan-Dec;27:2515690X221078006. doi: 10.1177/2515690X221078006.

  PMID: 35225720 BACKGROUND

• Jafari H, Gholamrezaei A, Franssen M, Van Oudenhove L, Aziz Q, Van den Bergh O, Vlaeyen JWS, Van Diest I. Can Slow Deep Breathing Reduce Pain? An Experimental Study Exploring Mechanisms. J Pain. 2020 Sep-Oct;21(9-10):1018-1030. doi: 10.1016/j.jpain.2019.12.010. Epub 2020 Jan 22.

  PMID: 31978501 BACKGROUND

• Hanley AW, Gililland J, Garland EL. To be mindful of the breath or pain: Comparing two brief preoperative mindfulness techniques for total joint arthroplasty patients. J Consult Clin Psychol. 2021 Jul;89(7):590-600. doi: 10.1037/ccp0000657. Epub 2021 Jun 24.

  PMID: 34165999 BACKGROUND

• Garcia-Galicia A, Diaz-Diaz JF, Montiel-Jarquin AJ, Gonzalez-Lopez AM, Vazquez-Cruz E, Morales-Flores CF. Validity and consistency of an outpatient department user satisfaction rapid scale. Gac Med Mex. 2020;156(1):47-52. doi: 10.24875/GMM.19005144.

  PMID: 32026871 BACKGROUND

• Ferrer-Pena R, Gil-Martinez A, Pardo-Montero J, Jimenez-Penick V, Gallego-Izquierdo T, La Touche R. Adaptation and validation of the Spanish version of the graded chronic pain scale. Reumatol Clin. 2016 May-Jun;12(3):130-8. doi: 10.1016/j.reuma.2015.07.004. Epub 2015 Aug 19. English, Spanish.

  PMID: 26298083 BACKGROUND

• Dilek B, Ayhan C, Yagci G, Yakut Y. Effectiveness of the graded motor imagery to improve hand function in patients with distal radius fracture: A randomized controlled trial. J Hand Ther. 2018 Jan-Mar;31(1):2-9.e1. doi: 10.1016/j.jht.2017.09.004. Epub 2017 Nov 6.

  PMID: 29122370 BACKGROUND

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 BACKGROUND

• Darnall BD, Abshire L, Courtney RE, Davin S. Upskilling pain relief after surgery: a scoping review of perioperative behavioral intervention efficacy and practical considerations for implementation. Reg Anesth Pain Med. 2025 Feb 5;50(2):93-101. doi: 10.1136/rapm-2024-105601.

  PMID: 39909552 BACKGROUND

• Birch S, Stilling M, Mechlenburg I, Hansen TB. No effect of cognitive behavioral patient education for patients with pain catastrophizing before total knee arthroplasty: a randomized controlled trial. Acta Orthop. 2020 Feb;91(1):98-103. doi: 10.1080/17453674.2019.1694312. Epub 2019 Nov 25.

  PMID: 31762342 BACKGROUND

MeSH Terms

Conditions

Agnosia; Acute Pain

Interventions

Imagery, Psychotherapy; Osteogenesis, Distraction; Whole Body Imaging

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Bone Lengthening; Orthopedic Procedures; Surgical Procedures, Operative; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Andrés F Calvo Abaunza, MSc

CONTACT

+573007795669; andres.calvo@uptc.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind (outcomes assessor). An external evaluator, not present during the intervention and unaware of group assignment (arms labeled A/B/C), administers and scores prespecified secondary outcomes-Pain Self-Efficacy Questionnaire (PSEQ-10), Pain Catastrophizing Scale (PCS), and Hospital Anxiety (HADS-A)-and has no access to baseline scores at the time of assessment. Participants and interventionists are not blinded. The primary outcome (acute pain 0-10) is patient-reported at bedside. Allocation is concealed until assignment (computer-generated variable blocks). Any inadvertent unblinding is documented.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full-Time Lecturer, School of Psychology

Model Details: Individually randomized, three-arm, parallel assignment (1:1:1) comparing two brief behavioral techniques-body-scan mindfulness and guided imagery/distraction-with an active comparator (CBT-based psychoeducation). Randomization uses computer-generated variable block sizes with allocation concealment until assignment. Open-label, single-session interventions delivered at the bedside with pre- and post-session pain assessment.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 28, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 16, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Within 12 months after publication of the primary results; available for 24 months thereafter.
• 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.

Locations

CO (4)