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)

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05435508
• Other study ID #: INeurocienciaDolor
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2023
• Source: Instituto Neurociencia Del Dolor
• Contact: Miguel Calva Maldonado, MD
• Phone: +52 2222932532
• Email: miguel.calvamal[@]correo.buap.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Anxiety
• Anxiety Disorders
• Chronic Pain
• Pain, Chronic
• Pain, Postoperative
• Stress
• Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Hospital Univeristario Benemerita Universidad Autonoma de Puebla	Puebla

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Neurociencia Del Dolor	Hospital Univeristario Benemerita Universidad Autonoma de Puebla

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

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. — View 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 preoperativ — View 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. — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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