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)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

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

Intervention / Treatment
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* Other: Pain Neuroscience Education
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anesthesia Physical Classification System: I, II or III according to the classification of the American Society of Anesthesiology. Acceptance of informed consent Schooling of at least 12 years (basic primary and secondary). Exclusion Criteria: Illiterate Inflammatory rheumatic disease Major neurological or psychiatric disease, Intellectual disability (mental retardation) or learning disorders at the premorbid level or severe language comprehension problems.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Neurosicence Education + Pre-anesthetic Assessment<br>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<br>* 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.<br>* Other names: Pain Neurophysiology Education;|
| Other: Pre-anesthetic Assessment (Usual Care)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale-Pain (EVA) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain neuroscience education, Hysterectomy, Pre-anesthetic Assessment