Efficacy of Pain Neuroscience Education and Pre-anesthetic Assessment in Reducing Levels of Anxiety, Stress and Pain in Patients Undergoing Elective Total Abdominal Hysterectomy (ENAH Study)

NCT05435508 | Completed DMC

• 1 other identifier: INeurocienciaDolor
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Chronic; Pain, Postoperative; Anesthesia; Surgery; Anxiety; Stress

Keywords

Pain neuroscience education; Hysterectomy; Pre-anesthetic Assessment

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Other: Pain Neuroscience Education; Other: Usual care

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.

Other: Usual care

Interventions

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.

Also known as: Therapeutic Neuroscience Education, Pain Neurophysiology Education

Experimental: Pain Neuroscience Education plus Pre-anesthetic Assessment

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.

Experimental: Pain Neuroscience Education plus Pre-anesthetic Assessment; Pre-anesthetic Assessment (Usual Care)

Eligibility Criteria

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

You may qualify if:

• Anesthesia Physical Classification System: I, II or III according to the classification of the American Society of Anesthesiology.
• Acceptance of informed consent
• Basic literacy skills sufficient to understand and complete study questionnaires.

You may not qualify if:

• Inability to understand study procedures or complete questionnaires.
• Inflammatory rheumatic disease
• Major neurological or psychiatric disease, Intellectual disability (mental retardation) or learning disorders at the premorbid level or severe language comprehension problems.

Sponsors & Collaborators

• Instituto Neurociencia Del Dolor: lead
• Hospital Univeristario Benemerita Universidad Autonoma de Puebla: collaborator

Study Sites (1)

Hospital Univeristario Benemerita Universidad Autonoma de Puebla

Puebla City, 72410, Mexico

Location

Related Publications (7)

• 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.

  PMID: 26264829 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.

  PMID: 26897450 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.

  PMID: 30921465 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.

  PMID: 17457133 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.

  PMID: 27931701 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.

  PMID: 35270250 RESULT

• 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.

  PMID: 41082712 DERIVED

MeSH Terms

Conditions

Chronic Pain; Pain, Postoperative; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Mental Disorders

Study Officials

• Johana Milena Mejía-Mejía, 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 28, 2022
• Study Start: July 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 15, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)