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)

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05435508

Enrollment

Registered

2022-06-28

Start date

2024-07-01

Completion date

2025-03-15

Last updated

2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pain neuroscience education, Hysterectomy, Pre-anesthetic Assessment

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.

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.

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Visual Analog Scale-Pain (EVA)	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.
Change in Perceived Stress Scale - 14 items (PSS-14)	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.
Change in Beck Anxiety Inventory (BAI)	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.

Countries

Mexico

Contacts

PRINCIPAL_INVESTIGATORJohana Milena Mejía-Mejía, MD

Hospital Universitario de Puebla BUAP

STUDY_CHAIRLeidy Tatiana Ordoñez-Mora, MsC

Universidad Santiago de Cali, Cali, Colombia.

STUDY_CHAIRMichelle Dassaaejv Macias Amezcua, MD