Efficacy of Pain Neuroscience Education and Pre-anesthetic Assessment in Reducing Levels of Anxie… (NCT05435508) | Clinical Trial Compass
CompletedNot Applicable
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)
Mexico62 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Anesthesia Physical Classification System: I, II or III according to the classification of the American Society of Anesthesiology.
. Acceptance of informed consent
. Basic literacy skills sufficient to understand and complete study questionnaires.
Exclusion criteria
. Inability to understand study procedures or complete questionnaires.
. Inflammatory rheumatic disease
. Major neurological or psychiatric disease, Intellectual disability (mental retardation) or learning disorders at the premorbid level or severe language comprehension problems.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Visual Analog Scale-Pain (EVA)
Timeframe: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
2
Change in Perceived Stress Scale - 14 items (PSS-14)
Timeframe: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
3
Change in Beck Anxiety Inventory (BAI)
Timeframe: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative