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| Name | Class |
|---|---|
| Hospital Univeristario Benemerita Universidad Autonoma de Puebla | OTHER |
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Through this quantitative, multivariate factorial experimental parallel randomized clinical trial, the investigators analyzed the effectiveness of pre-anesthetic assessment and pain neuroscience education in reducing anxiety, stress, and pain levels in patients undergoing elective total abdominal hysterectomy.
Hysterectomy is a common surgical procedure with a low risk of major complications. However, some women experience long-lasting complications, including chronic postsurgical pain, which can have a negative impact on their quality of life.
The population will be made up of women with elective total abdominal hysterectomy scheduled surgery at the University Hospital of Puebla BUAP, in the city of Puebla, Mexico.
Then the investigators will carry out an pre-anesthetic evaluation will be carried out and an pain neuroscience education session will be carried out.
Once patients are ready for surgery, the investigators will carry out an invasive monitoring will be performed in the post-anesthesia care unit. The blood pressure of the participants will be monitored non-invasively. They will also be monitored with electrocardiogram and pulse oximetry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Pain Neuroscience Education plus Pre-anesthetic Assessment | Experimental | Participants assigned to this arm received one face-to-face Pain Neuroscience Education (PNE) session (approximately 35 minutes) in addition to the standard pre-anesthetic assessment. PNE consisted of an educational intervention focused on the neurobiology and neurophysiology of pain and pain processing by the nervous system. |
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| Pre-anesthetic Assessment (Usual Care) | Other | Participants assigned to this arm received standard pre-anesthetic assessment (usual care), which included evaluation of physical condition, medical and surgical history, and laboratory tests, in order to establish surgical risk and define the anesthetic plan according to the surgical procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Neuroscience Education | Other | One face-to-face Pain Neuroscience Education (PNE) session was delivered by a professional certified in PNE, with a duration of approximately 35 minutes. The session addressed the neurobiology and neurophysiology of pain, central sensitization, cortical representation of body regions, pain-related changes in body perception, and psychosocial dimensions of pain. Participants also received standard pre-anesthetic assessment, identical to the usual care group. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale-Pain (EVA) | Pain intensity at rest was assessed using a 10-cm visual analog scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. | Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative |
| Change in Perceived Stress Scale - 14 items (PSS-14) | Perceived stress was assessed using the 14-item Perceived Stress Scale (PSS-14). Each item is rated on a 5-point Likert scale (0-4), yielding a total score ranging from 0 to 56, with higher scores indicating greater perceived stress. | Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative |
| Change in Beck Anxiety Inventory (BAI) | Anxiety symptoms were assessed using the Beck Anxiety Inventory (BAI), a 21-item self-reported questionnaire. Each item is scored from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate greater anxiety severity. | Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johana Milena MejÃa-MejÃa, MD | Hospital Universitario de Puebla BUAP | Principal Investigator |
| Leidy Tatiana Ordoñez-Mora, MsC | Universidad Santiago de Cali, Cali, Colombia. | Study Chair |
| Michelle Dassaaejv Macias Amezcua, MD | Hospital Universitario de Puebla BUAP | Study Chair |
| Pedro Javier López-Perez, PhD | Universidad de la Costa, Barranquilla, Colombia | Study Chair |
| Marco Antonio Morales-Osorio, PhD | Universidad Arturo Prat, Iquique, Chile. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Univeristario Benemerita Universidad Autonoma de Puebla | Puebla City | 72410 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26264829 | Result | Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5. | |
| 26897450 | Result | Attias S, Keinan Boker L, Arnon Z, Ben-Arye E, Bar'am A, Sroka G, Matter I, Somri M, Schiff E. Effectiveness of integrating individualized and generic complementary medicine treatments with standard care versus standard care alone for reducing preoperative anxiety. J Clin Anesth. 2016 Mar;29:54-64. doi: 10.1016/j.jclinane.2015.10.017. Epub 2016 Feb 2. |
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Parallel Assignment
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Participants and outcome assessors were blinded to group allocation. Care providers and the investigator delivering the intervention were not blinded due to the nature of the intervention. Data analysts remained blinded during statistical analysis.
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| Usual care | Other | Usual care consisted of standard pre-anesthetic assessment and routine perioperative management, including analgesic medication administered before, during, and after hysterectomy, according to institutional protocols and the clinical judgment of the attending physician. |
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| 30921465 | Result | Goudman L, Huysmans E, Ickmans K, Nijs J, Moens M, Putman K, Buyl R, Louw A, Logghe T, Coppieters I. A Modern Pain Neuroscience Approach in Patients Undergoing Surgery for Lumbar Radiculopathy: A Clinical Perspective. Phys Ther. 2019 Jul 1;99(7):933-945. doi: 10.1093/ptj/pzz053. |
| 17457133 | Result | Brandsborg B, Nikolajsen L, Hansen CT, Kehlet H, Jensen TS. Risk factors for chronic pain after hysterectomy: a nationwide questionnaire and database study. Anesthesiology. 2007 May;106(5):1003-12. doi: 10.1097/01.anes.0000265161.39932.e8. |
| 27931701 | Result | Gursoy A, Candas B, Guner S, Yilmaz S. Preoperative Stress: An Operating Room Nurse Intervention Assessment. J Perianesth Nurs. 2016 Dec;31(6):495-503. doi: 10.1016/j.jopan.2015.08.011. Epub 2016 May 6. |
| 35270250 | Result | Ordonez-Mora LT, Morales-Osorio MA, Rosero ID. Effectiveness of Interventions Based on Pain Neuroscience Education on Pain and Psychosocial Variables for Osteoarthritis: A Systematic Review. Int J Environ Res Public Health. 2022 Feb 23;19(5):2559. doi: 10.3390/ijerph19052559. |
| 41082712 | Derived | Morales-Osorio MA, Mejia-Mejia J, Calva Maldonado M, Pablo Yanez JC, Ordonez-Mora LT. Efficacy of preanesthetic assessment combined with pain neuroscience education in reducing anxiety, stress, and pain in elective hysterectomy: A randomized controlled trial protocol. Medwave. 2025 Oct 13;25(9):e3092. doi: 10.5867/medwave.2025.09.3092. |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010149 | Pain, Postoperative |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D001523 | Mental Disorders |
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