Pain ManagementNCT07254923
Three Brief Psychological Interventions for Acute Pain in Inpatients in Boyacá
A study testing Guided Imagery, Body-Scan Mindfulness and CBT-Based Psychoeducation (ABC Model) in people with Pain Management and Pain Acute, run by Universidad Pedagógica y Tecnológica de Colombia at 4 sites in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain Management, Pain Acute
- What is being tested?
- Guided Imagery, Body-Scan Mindfulness and CBT-Based Psychoeducation (ABC Model)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesColombia
- Study dates
- Jan 2026to 16 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia4 sites
ESE Hospital Regional de Chiquinquirá
Chiquinquirá, Departamento de Boyacá, 154640
ESE Hospital Santa Marta de Samacá
Samacá, Departamento de Boyacá, 153660
Diana Johana Malpica Humo, Presidente Comité de calidad, +57 608 7372008, esehospitalsamaca@hotmai.com
Jhon F Buitrago, MG
ESE Hospital Regional de Sogamoso
Sogamoso, Departamento de Boyacá, 152210
Aliette Yamile Aranguren Sanchez, +573157070733, docenciaeinnovacionhrs@gmail.com
Claudia Elena García Aragón, Mg
ESE Santiago de Tunja
Tunja, Departamento de Boyacá, 150001
Laura Gonzalez, nurse, +573233240523, aulavirtual@esesantiagodetunja.gov.co
Andrés Calvo, MSc
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain Management, Pain Acute
- Being tested
- Guided Imagery, Body-Scan Mindfulness, CBT-Based Psychoeducation (ABC Model)
- Keywords
- body scanning, ABC, Guided Imagery, Breathing Exercises, Acute Pain, Pain Measurement, Pain Management, Inpatients, Randomized Controlled Trial
- Medical subject headings
- Agnosia, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryBehavioural
Also called Distraction
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 MindfulnessBehavioural
Also called body scan
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)Behavioural
Also called ABC Model Education, Cognitive Behavioral Psychoeducation
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: CBT-Based Psychoeducation (ABC Model) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: One assessment 5-10 minutes after session end (same calendar day).
Hospital Anxiety (HADS-A) - change from pre-session to post-session
7-item Hospital Anxiety subscale (0-21). Higher scores = more anxiety. Administered by a blinded outcomes assessor.
Measured: One assessment 5-10 minutes after session end (same calendar day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study startJan 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Pedagógica y Tecnológica de Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- ESE Hospital Regional de Sogamoso, ESE Hospital Santa Marta de Samacá, ESE Santiago de Tunja, ESE Hospital Regional de Chiquinquirá
- Responsible party
- Principal investigator, Andrés Felipe Calvo-Abaunza, Universidad Pedagógica y Tecnológica de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254923
- Sponsor's protocol ID
- RCT-PSI-01
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 32772319Miller-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.
PubMed 31329961Maniaci 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.
PubMed 39543797Joseph 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.
PubMed 35225720Jafari 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.
PubMed 31978501Hanley 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.
PubMed 34165999Garcia-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.
PubMed 32026871Ferrer-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.
PubMed 26298083Dilek 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.
PubMed 29122370Delgado 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.
PubMed 30211382Darnall 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.
PubMed 39909552Birch 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.
PubMed 31762342
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Brief Psychological Interventions for Acute Pain in Inpatients in Boyacá: Randomized Three-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07254923
- Acronym / sponsor ID
- RCT-PSI-01
- Conditions
- Pain Management, Pain Acute
- Keywords
- body scanning, ABC, Guided Imagery, Breathing Exercises, Acute Pain, Pain Measurement, Pain Management, Inpatients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Universidad Pedagógica y Tecnológica de ColombiaUniversity, hospital or other
- Collaborators
- ESE Hospital Regional de Sogamoso, ESE Hospital Santa Marta de Samacá, ESE Santiago de Tunja, ESE Hospital Regional de Chiquinquirá
- Study start
- Jan 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery (B) | Experimental | Behavioral: Guided ImagerySingle, 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. |
| Body-Scan Mindfulness (A) | Experimental | Behavioral: Body-Scan MindfulnessSingle, 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. |
| CBT-Based Psychoeducation (ABC Model) (C) | Active comparator | Behavioral: CBT-Based Psychoeducation (ABC Model)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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided ImageryAlso: DistractionSingle, 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). | Behavioural | Guided Imagery (B) |
| Body-Scan MindfulnessAlso: body scanSingle, 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). | Behavioural | Body-Scan Mindfulness (A) |
| CBT-Based Psychoeducation (ABC Model)Also: ABC Model Education, Cognitive Behavioral PsychoeducationBrief, 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). | Behavioural | CBT-Based Psychoeducation (ABC Model) (C) |
Primary outcome
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).
5 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Background: PubMed 32772319Sun 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.
- Background: PubMed 31329961Miller-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.
- Background: PubMed 39543797Maniaci 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.
- Background: PubMed 35225720Joseph 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.
- Background: PubMed 31978501Jafari 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.
- Background: PubMed 34165999Hanley 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.
- Background: PubMed 32026871Garcia-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.
- Background: PubMed 26298083Ferrer-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.
- Background: PubMed 29122370Dilek 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.
- Background: PubMed 30211382Delgado 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.
- Background: PubMed 39909552Darnall 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.
- Background: PubMed 31762342Birch 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery, Body-Scan Mindfulness and CBT-Based Psychoeducation (ABC Model) in people with Pain Management and Pain Acute, run by Universidad Pedagógica y Tecnológica de Colombia at 4 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrés F Calvo Abaunza, MSc (+573007795669, andres.calvo@uptc.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07254923, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.