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CompletedNCT05435508Updated Sep 2, 2026

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)

An interventional study of Pain Neuroscience Education and Usual care in Pain, Chronic, Pain, Postoperative and Anesthesia, sponsored by Instituto Neurociencia Del Dolor. Completed at 1 site in Mexico. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Instituto Neurociencia Del Dolor · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

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Conditions studied

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

Keywords

  • Pain neuroscience education
  • Hysterectomy
  • Pre-anesthetic Assessment
03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 62 is close to the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Instituto Neurociencia Del Dolor is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • 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 · Other: Usual care

  • 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

Interventions

  • OtherPain 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.

    Also known as: Therapeutic Neuroscience Education, Pain Neurophysiology Education

  • OtherUsual 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative

  2. 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.

    Time frame: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative

  3. 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.

    Time frame: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative

07

Study locations

1 site
  • Hospital Univeristario Benemerita Universidad Autonoma de Puebla
    Puebla City, 72410, Mexico
08

References and documents

Publications

  • 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. PubMed 41082712 ↗

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05435508
Lead sponsor
Instituto Neurociencia Del Dolor
Collaborators
Hospital Univeristario Benemerita Universidad Autonoma de Puebla
Responsible party
Sponsor
First posted
Jun 28, 2022
Start date
Jul 1, 2024
Primary completion
Feb 28, 2025
Completion
Mar 15, 2025
Last update
Sep 2, 2026

Study contacts

Johana Milena Mejía-Mejía, MD
principal investigator · Hospital Universitario de Puebla BUAP
Leidy Tatiana Ordoñez-Mora, MsC
study chair · Universidad Santiago de Cali, Cali, Colombia.
Michelle Dassaaejv Macias Amezcua, MD
study chair · Hospital Universitario de Puebla BUAP
Marco Antonio Morales-Osorio, PhD
study director · Universidad Arturo Prat, Iquique, Chile.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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