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)

December 22, 2025 updated by: Instituto Neurociencia Del Dolor

Efficacy in Reducing Anxiety, Stress, and Pain Levels Through Preanesthetic Assessment and Pain Neuroscience Education in Patients Undergoing Elective Total Abdominal Hysterectomy: A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Puebla City, Mexico, 72410
        • Hospital Univeristario Benemerita Universidad Autonoma de Puebla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Pain Neuroscience Education plus Pre-anesthetic Assessment
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
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.
Other Names:
  • Therapeutic Neuroscience Education
  • Pain Neurophysiology Education
Other: Usual care
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.
Other: Pre-anesthetic Assessment (Usual Care)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analog Scale-Pain (EVA)
Time Frame: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
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)
Time Frame: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
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)
Time Frame: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Neurociencia Del Dolor

Collaborators

Hospital Univeristario Benemerita Universidad Autonoma de Puebla

Investigators

  • Principal Investigator: Johana Milena Mejía-Mejía, MD, Hospital Universitario de Puebla BUAP
  • Study Chair: 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 Director: Marco Antonio Morales-Osorio, PhD, Universidad Arturo Prat, Iquique, Chile.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

March 15, 2025

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (Actual)

June 28, 2022

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INeurocienciaDolor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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