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)

Not Applicable

Recruiting

• Conditions: Anesthesia; Surgery; Anxiety; Pain, Chronic; Pain, Postoperative; Stress
• Interventions: Other: Pain Neuroscience Education; Other: Usual care

• Registration Number: NCT05435508
• Lead Sponsor: Instituto Neurociencia Del Dolor

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-28
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01
• Study Start: 2023-07-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Neurosicence Education + Pre-anesthetic Assessment	Pain Neuroscience Education	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.
Pre-anesthetic Assessment (Usual Care)	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.

Primary Outcome Measures

Name	Time	Method
Change in Beck Anxiety Inventory (BAI)	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".
Change in Perceived Stress Scale (PSS)	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
Change in Visual Analog Scale-Pain (EVA)	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.

Trial Locations

Locations (1)

Hospital Univeristario Benemerita Universidad Autonoma de Puebla; 🇲🇽 Puebla, Mexico