Clinical trial NCT05435508: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Chronic
Pain, Postoperative
Anesthesia
Surgery
Anxiety
Stress
Keywords: Pain neuroscience education
Hysterectomy
Pre-anesthetic Assessment
Lead sponsor: Instituto Neurociencia Del Dolor
Sponsor class: OTHER
Collaborators: name: Hospital Univeristario Benemerita Universidad Autonoma de Puebla
First posted: 2022-06-28
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Visual Analog Scale-Pain (EVA)
timeFrame: At baseline and through intervention's completion, 1 day
measure: Change in Perceived Stress Scale (PSS)
timeFrame: At baseline and through intervention's completion, 1 day
measure: Change in Beck Anxiety Inventory (BAI)
timeFrame: At baseline and through intervention's completion, 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Puebla
country: Mexico
facility: Hospital Univeristario Benemerita Universidad Autonoma de Puebla
Study officials:
affiliation: Hospital Universitario de Puebla BUAP
name: Johana Milena Mejía-Mejía, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Santiago de Cali, Cali, Colombia.
name: Leidy Tatiana Ordoñez-Mora, MsC
role: STUDY_CHAIR
affiliation: Hospital Universitario de Puebla BUAP
name: Michelle Dassaaejv Macias Amezcua, MD
role: STUDY_CHAIR
affiliation: Universidad de la Costa, Barranquilla, Colombia
name: Pedro Javier López-Perez, PhD
role: STUDY_CHAIR
affiliation: Universidad Arturo Prat, Iquique, Chile.
name: Marco Antonio Morales-Osorio, PhD
role: STUDY_DIRECTOR
References:
citation: Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.
citation: Attias S, Keinan Boker L, Arnon Z, Ben-Arye E, Bar'am A, Sroka G, Matter I, Somri M, Schiff E. Effectiveness of integrating individualized and generic complementary medicine treatments with standard care versus standard care alone for reducing preoperative anxiety. J Clin Anesth. 2016 Mar;29:54-64. doi: 10.1016/j.jclinane.2015.10.017. Epub 2016 Feb 2.
citation: Goudman L, Huysmans E, Ickmans K, Nijs J, Moens M, Putman K, Buyl R, Louw A, Logghe T, Coppieters I. A Modern Pain Neuroscience Approach in Patients Undergoing Surgery for Lumbar Radiculopathy: A Clinical Perspective. Phys Ther. 2019 Jul 1;99(7):933-945. doi: 10.1093/ptj/pzz053.
citation: Brandsborg B, Nikolajsen L, Hansen CT, Kehlet H, Jensen TS. Risk factors for chronic pain after hysterectomy: a nationwide questionnaire and database study. Anesthesiology. 2007 May;106(5):1003-12. doi: 10.1097/01.anes.0000265161.39932.e8.
citation: Gursoy A, Candas B, Guner S, Yilmaz S. Preoperative Stress: An Operating Room Nurse Intervention Assessment. J Perianesth Nurs. 2016 Dec;31(6):495-503. doi: 10.1016/j.jopan.2015.08.011. Epub 2016 May 6.
citation: Ordonez-Mora LT, Morales-Osorio MA, Rosero ID. Effectiveness of Interventions Based on Pain Neuroscience Education on Pain and Psychosocial Variables for Osteoarthritis: A Systematic Review. Int J Environ Res Public Health. 2022 Feb 23;19(5):2559. doi: 10.3390/ijerph19052559.