Three Brief Psychological Interventions for Acute Pain in Inpatients in Boyacá
NCT ID: NCT07254923
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
160 participants
INTERVENTIONAL
2026-01-31
2026-12-16
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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).
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.
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).
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.
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).
Interventions
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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).
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).
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
No
Sponsors
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ESE Hospital Regional de Sogamoso
UNKNOWN
ESE Hospital Santa Marta de Samacá
UNKNOWN
ESE Santiago de Tunja
UNKNOWN
ESE Hospital Regional de Chiquinquirá
UNKNOWN
Universidad Pedagógica y Tecnológica de Colombia
OTHER
Responsible Party
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Andrés Felipe Calvo-Abaunza
Full-Time Lecturer, School of Psychology
Locations
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ESE Hospital Regional de Chiquinquirá
Chiquinquirá, Departamento de Boyacá, Colombia
ESE Hospital Santa Marta de Samacá
Samacá, Departamento de Boyacá, Colombia
ESE Hospital Regional de Sogamoso
Sogamoso, Departamento de Boyacá, Colombia
ESE Santiago de Tunja
Tunja, Departamento de Boyacá, Colombia
Countries
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Central Contacts
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Facility Contacts
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Diana Johana Malpica Humo, Presidente Comité de calidad
Role: primary
Aliette Yamile Aranguren Sanchez
Role: primary
Laura Gonzalez, nurse
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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RCT-PSI-01
Identifier Type: -
Identifier Source: org_study_id