Three Brief Psychological Interventions for Acute Pain in Inpatients in Boyacá

Official title

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

Overview

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.

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.

Interventions

• 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).
• 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).
• 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).

Primary outcome measures

• 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.]

Secondary outcome measures (5)

• Patient satisfaction with the session [Time frame: 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).]
• Pain Self-Efficacy (PSEQ-10) - change from pre- to post-session [Time frame: 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).]
• Hospital Anxiety (HADS-A) - change from pre-session to post-session [Time frame: One assessment 5-10 minutes after session end (same calendar day).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Colombia · 4 centers

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

Publications

• 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
• 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
• 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/ PMID 39543797
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07254923 · RCT-PSI-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗