Pain, ChronicNCT05435508
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)
A study testing Pain Neuroscience Education in people with Pain, Chronic and Pain, Postoperative, run by Instituto Neurociencia Del Dolor at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain, Chronic, Pain, Postoperative, Anesthesia
- What is being tested?
- Pain Neuroscience Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Univeristario Benemerita Universidad Autonoma de Puebla
Puebla City, Puebla, 72410
About this 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
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.
Read the 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.
- Conditions
- Pain, Chronic, Pain, Postoperative, Anesthesia, Surgery, Anxiety, Stress
- Being tested
- Pain Neuroscience Education, Usual care
- Keywords
- Pain neuroscience education, Hysterectomy, Pre-anesthetic Assessment
- Medical subject headings
- Chronic Pain, Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationOther
Also called Therapeutic Neuroscience Education, Pain Neurophysiology Education
One face-to-face Pain Neuroscience Education (PNE) session was delivered by a professional certified in PNE, with a duration of approximately 35 minutes. The session addressed the neurobiology and neurophysiology of pain, central sensitization, cortical representation of body regions, pain-related changes in body perception, and psychosocial dimensions of pain. Participants also received standard pre-anesthetic assessment, identical to the usual care group.
Usual careOther
Usual care consisted of standard pre-anesthetic assessment and routine perioperative management, including analgesic medication administered before, during, and after hysterectomy, according to institutional protocols and the clinical judgment of the attending physician.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Pain Neuroscience Education plus Pre-anesthetic Assessment | Experimental | Participants assigned to this arm received one face-to-face Pain Neuroscience Education (PNE) session (approximately 35 minutes) in addition to the standard pre-anesthetic assessment. PNE consisted of an educational intervention focused on the neurobiology and neurophysiology of pain and pain processing by the nervous system. Receives: Other: Pain Neuroscience Education; Other: Usual care |
| Pre-anesthetic Assessment (Usual Care) | Other | Participants assigned to this arm received standard pre-anesthetic assessment (usual care), which included evaluation of physical condition, medical and surgical history, and laboratory tests, in order to establish surgical risk and define the anesthetic plan according to the surgical procedure. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale-Pain (EVA)
Pain intensity at rest was assessed using a 10-cm visual analog scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
Change in Perceived Stress Scale - 14 items (PSS-14)
Perceived stress was assessed using the 14-item Perceived Stress Scale (PSS-14). Each item is rated on a 5-point Likert scale (0-4), yielding a total score ranging from 0 to 56, with higher scores indicating greater perceived stress.
Measured: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
Change in Beck Anxiety Inventory (BAI)
Anxiety symptoms were assessed using the Beck Anxiety Inventory (BAI), a 21-item self-reported questionnaire. Each item is scored from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate greater anxiety severity.
Measured: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Jul 2024
- Primary completion28 Feb 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Neurociencia Del Dolor
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Univeristario Benemerita Universidad Autonoma de Puebla
- Responsible party
- Sponsor
- Investigators
- Johana Milena Mejía-Mejía, MD, Principal investigator, Hospital Universitario de Puebla BUAPLeidy Tatiana Ordoñez-Mora, MsC, Study chair, Universidad Santiago de Cali, Cali, Colombia.Michelle Dassaaejv Macias Amezcua, MD, Study chair, Hospital Universitario de Puebla BUAPMarco Antonio Morales-Osorio, PhD, Study director, Universidad Arturo Prat, Iquique, Chile.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435508
- Sponsor's protocol ID
- INeurocienciaDolor
- Status last verified
- Nov 2026
- First submitted
- 22 Jun 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) collected during the trial will be shared after pseudonymization.
Publications
Morales-Osorio MA, Mejia-Mejia J, Calva Maldonado M, Pablo Yanez JC, Ordonez-Mora LT. Efficacy of preanesthetic assessment combined with pain neuroscience education in reducing anxiety, stress, and pain in elective hysterectomy: A randomized controlled trial protocol. Medwave. 2025 Oct 13;25(9):e3092. doi: 10.5867/medwave.2025.09.3092.
PubMed 41082712
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05435508
- Acronym / sponsor ID
- INeurocienciaDolor
- Conditions
- Pain, Chronic, Pain, Postoperative, Anesthesia, Surgery, Anxiety, Stress
- Keywords
- Pain neuroscience education, Hysterectomy, Pre-anesthetic Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Instituto Neurociencia Del DolorUniversity, hospital or other
- Collaborators
- Hospital Univeristario Benemerita Universidad Autonoma de Puebla
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental: Pain Neuroscience Education plus Pre-anesthetic Assessment | Experimental | Other: Pain Neuroscience Education, Other: Usual careParticipants assigned to this arm received one face-to-face Pain Neuroscience Education (PNE) session (approximately 35 minutes) in addition to the standard pre-anesthetic assessment. PNE consisted of an educational intervention focused on the neurobiology and neurophysiology of pain and pain processing by the nervous system. |
| Pre-anesthetic Assessment (Usual Care) | Other | Other: Usual careParticipants assigned to this arm received standard pre-anesthetic assessment (usual care), which included evaluation of physical condition, medical and surgical history, and laboratory tests, in order to establish surgical risk and define the anesthetic plan according to the surgical procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Neuroscience EducationAlso: Therapeutic Neuroscience Education, Pain Neurophysiology EducationOne face-to-face Pain Neuroscience Education (PNE) session was delivered by a professional certified in PNE, with a duration of approximately 35 minutes. The session addressed the neurobiology and neurophysiology of pain, central sensitization, cortical representation of body regions, pain-related changes in body perception, and psychosocial dimensions of pain. Participants also received standard pre-anesthetic assessment, identical to the usual care group. | Other | Experimental: Pain Neuroscience Education plus Pre-anesthetic Assessment |
| Usual careUsual care consisted of standard pre-anesthetic assessment and routine perioperative management, including analgesic medication administered before, during, and after hysterectomy, according to institutional protocols and the clinical judgment of the attending physician. | Other | Experimental: Pain Neuroscience Education plus Pre-anesthetic Assessment, Pre-anesthetic Assessment (Usual Care) |
Primary outcome
Change in Visual Analog Scale-Pain (EVA)
Time frame: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
Pain intensity at rest was assessed using a 10-cm visual analog scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Change in Perceived Stress Scale - 14 items (PSS-14)
Time frame: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
Perceived stress was assessed using the 14-item Perceived Stress Scale (PSS-14). Each item is rated on a 5-point Likert scale (0-4), yielding a total score ranging from 0 to 56, with higher scores indicating greater perceived stress.
Change in Beck Anxiety Inventory (BAI)
Time frame: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
Anxiety symptoms were assessed using the Beck Anxiety Inventory (BAI), a 21-item self-reported questionnaire. Each item is scored from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate greater anxiety severity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 41082712Morales-Osorio MA, Mejia-Mejia J, Calva Maldonado M, Pablo Yanez JC, Ordonez-Mora LT. Efficacy of preanesthetic assessment combined with pain neuroscience education in reducing anxiety, stress, and pain in elective hysterectomy: A randomized controlled trial protocol. Medwave. 2025 Oct 13;25(9):e3092. doi: 10.5867/medwave.2025.09.3092.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) collected during the trial will be shared after pseudonymization.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johana Milena Mejía-Mejía, MD principal investigator
Hospital Universitario de Puebla BUAP
Leidy Tatiana Ordoñez-Mora, MsC study chair
Universidad Santiago de Cali, Cali, Colombia.
Michelle Dassaaejv Macias Amezcua, MD study chair
Hospital Universitario de Puebla BUAP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education in people with Pain, Chronic and Pain, Postoperative, run by Instituto Neurociencia Del Dolor at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale-Pain (EVA) (time frame: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.