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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)

Primary Purpose

Pain, Chronic, Pain, Postoperative, Anesthesia

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Pain Neuroscience Education
Usual care
Sponsored by
Instituto Neurociencia Del Dolor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic focused on measuring Pain neuroscience education, Hysterectomy, Pre-anesthetic Assessment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Univeristario Benemerita Universidad Autonoma de PueblaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Pain Neurosicence Education + Pre-anesthetic Assessment

Pre-anesthetic Assessment (Usual Care)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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
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".

Secondary Outcome Measures

Full Information

First Posted
June 22, 2022
Last Updated
February 27, 2023
Sponsor
Instituto Neurociencia Del Dolor
Collaborators
Hospital Univeristario Benemerita Universidad Autonoma de Puebla
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1. Study Identification

Unique Protocol Identification Number
NCT05435508
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Neurociencia Del Dolor
Collaborators
Hospital Univeristario Benemerita Universidad Autonoma de Puebla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Pain, Postoperative, Anesthesia, Surgery, Anxiety, Stress
Keywords
Pain neuroscience education, Hysterectomy, Pre-anesthetic Assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain Neurosicence Education + Pre-anesthetic Assessment
Arm Type
Experimental
Arm Description
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.
Arm Title
Pre-anesthetic Assessment (Usual Care)
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pain Neuroscience Education
Other Intervention Name(s)
Therapeutic Neuroscience Education, Pain Neurophysiology Education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale-Pain (EVA)
Description
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.
Time Frame
At baseline and through intervention's completion, 1 day
Title
Change in Perceived Stress Scale (PSS)
Description
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
Time Frame
At baseline and through intervention's completion, 1 day
Title
Change in Beck Anxiety Inventory (BAI)
Description
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".
Time Frame
At baseline and through intervention's completion, 1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Calva Maldonado, MD
Phone
+52 2222932532
Email
miguel.calvamal@correo.buap.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Julio Cesar Pablo Yañez, MD
Phone
+52 2223733304
Email
haller_@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johana Milena Mejía-Mejía, MD
Organizational Affiliation
Hospital Universitario de Puebla BUAP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leidy Tatiana Ordoñez-Mora, MsC
Organizational Affiliation
Universidad Santiago de Cali, Cali, Colombia.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michelle Dassaaejv Macias Amezcua, MD
Organizational Affiliation
Hospital Universitario de Puebla BUAP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pedro Javier López-Perez, PhD
Organizational Affiliation
Universidad de la Costa, Barranquilla, Colombia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marco Antonio Morales-Osorio, PhD
Organizational Affiliation
Universidad Arturo Prat, Iquique, Chile.
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Univeristario Benemerita Universidad Autonoma de Puebla
City
Puebla
ZIP/Postal Code
72410
Country
Mexico
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26264829
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.
Results Reference
result
PubMed Identifier
26897450
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.
Results Reference
result
PubMed Identifier
30921465
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.
Results Reference
result
PubMed Identifier
17457133
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.
Results Reference
result
PubMed Identifier
27931701
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.
Results Reference
result
PubMed Identifier
35270250
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.
Results Reference
result

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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)

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