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)

February 27, 2023 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 research of the Parallel Randomized Clinical Trial type, the investigators will try to analyze the effectiveness in reducing levels of anxiety, stress and pain through pre-anesthetic assessment and pain neuroscience education in patients undergoing elective total abdominal hysterectomy.

Study Overview

Status

Recruiting

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 (Anticipated)

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 Contact

Study Contact Backup

Study Locations

  • Mexico
      • Puebla, Mexico, 72410
        • Recruiting
        • 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

Genders Eligible for Study

Female

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. Schooling of at least 12 years (basic primary and secondary).

Exclusion Criteria:

  1. Illiterate
  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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pain Neurosicence Education + Pre-anesthetic Assessment
Pain neuroscience education + Pre-anesthetic Assessment. Pain neuroscience education can be defined as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system.
Other: Pain Neuroscience Education
A total of 1 PNE sessions (Neuroscience pain education) will be carried out, in addition medical treatment similar to control group (Usual care). The PNE sessions will be conducted by an experienced PNE certified proffesional in 35 minute face-to-face sessions. In PNE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain.
Other Names:
  • Therapeutic Neuroscience Education
  • Pain Neurophysiology Education
Other: Pre-anesthetic Assessment (Usual Care)
The pre-anesthetic assessment is the clinical study that allows evaluating the physical condition, personal, pathological and surgical history together with laboratory tests to be able to establish a surgical risk in order to define the best anesthetic plan that the patient requires according to the surgical event.
Other: Usual care
The control group (Usual care) is treated with pre-anesthetic assessment + usual treatment, management for analgesic medication pre, during and post hysterectomy. Depending on the medical needs and criteria of patients´s care physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analog Scale-Pain (EVA)
Time Frame: At baseline and through intervention's completion, 1 day
The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome.
At baseline and through intervention's completion, 1 day
Change in Perceived Stress Scale (PSS)
Time Frame: At baseline and through intervention's completion, 1 day
Significant differences among groups in the mean Perceived Stress Scale (PSS) score, which measures the stress severity perceived by the subjects in the last month. The scale is constituted by 10 items that are self-rated by the subject on a 0-4 Likert scale. The scale minimum total score is 0, the maximum is 40. Higher total scores indicate a worse outcome
At baseline and through intervention's completion, 1 day
Change in Beck Anxiety Inventory (BAI)
Time Frame: At baseline and through intervention's completion, 1 day
Beck Anxiety Inventory (BAI) is a 21-item self-reported questionnaire which measures the existenceand severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and 26 - 63 as "Severe".
At baseline and through intervention's completion, 1 day

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 (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

December 1, 2023

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)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

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

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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