- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07471269
Online Pain Neuroscience Education For Fear Of Childbirth.
Effectiveness Of An Online Pain Neuroscience Education Intervention In Reducing Fear Of Childbirth Among Pregnant Women.
Fear of childbirth ranges from mild worry to severe anxiety and affects women of all ages. It is often linked to perceiving childbirth as unpredictable and painful. Women cope by seeking support, practicing relaxation, or attending prenatal education, with information playing a key role in reducing anxiety and increasing confidence.
Pain neuroscience education has shown benefits in reducing pain, anxiety, and related fears by teaching the neurobiological mechanisms underlying pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Fear of childbirth is a psychological condition that can range from mild fear to extreme anxiety about childbirth. It can affect women of all ages, whether they are pregnant or not, and is often associated with the perception of childbirth as an unpredictable and painful process.
To cope with this fear, many women seek emotional and professional support, practice relaxation techniques, or participate in prenatal education. In this context, access to appropriate information can help reduce anxiety and strengthen confidence, promoting more positive childbirth experiences.
Among educational strategies, education in the neuroscience of pain has gained increasing attention in recent years due to its positive effects on reducing pain, pain catastrophizing, kinesiophobia, anxiety, and depression. This approach is based on reconceptualizing pain through the teaching of the neurobiological mechanisms underlying the pain experience.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: JF Lisón, Dr
- Phone Number: 0034606503108
- Email: juanfran@uchceu.es
Study Locations
-
-
Valencia
-
Alfara del Patriarca, Valencia, Spain, 46115
- Recruiting
- University Cardenal Herrera
-
Contact:
- JF Lisón, PhD
- Phone Number: 0034606503108
- Email: juanfran@uchceu.es
-
Contact:
- Gemma Biviá Roig, PhD
- Email: gemma.bivia@uchceu.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant women over 18 years of age, primiparous or multiparous.
- At the beginning of the third trimester of pregnancy
Exclusion Criteria:
- Multiple pregnancies.
- Previous spinal surgery.
- Psychiatric disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pain neuroscience education (PNE)
The patients in the intervention group will receive, in addition to the prenatal educational content, the 12 PNE lessons in audiovisual format.
Each lesson will last between 10-15 minutes.
The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler & Moseley postulates.
These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain.
In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples.
In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain.
|
The patients in the intervention group will receive, in addition to the prenatal educational content, the 12 Pain neuroscience education lessons in audiovisual format.
Each lesson will last between 10-15 minutes.
The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler & Moseley postulates.
These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain.
In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples.
In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain.
The standard prenatal education is based on the Pregnancy and Postpartum Clinical Practice Guide, consisting of general information about pregnancy (visits and monitoring of pregnancy, diet, phases of delivery, lactation, etc.), as well as specific recommendations for lumbopelvic pain associated with pregnancy.
These contents will be developed by midwives from the participating hospitals.
Participants will receive 12 educational sessions, with an estimated duration of 10 minutes each.
|
|
Experimental: Prenatal education (PE)
Patients assigned to the PE group will receive different content on standard PE based on the Pregnancy and Postpartum Clinical Practice Guide, consisting of general information about pregnancy (visits and monitoring of pregnancy, diet, phases of delivery, lactation, etc.), as well as specific recommendations for lumbopelvic pain associated with pregnancy.
These contents will be developed by midwives from the participating hospitals.
Participants will receive 12 educational sessions, with an estimated duration of 10 minutes each.
|
The standard prenatal education is based on the Pregnancy and Postpartum Clinical Practice Guide, consisting of general information about pregnancy (visits and monitoring of pregnancy, diet, phases of delivery, lactation, etc.), as well as specific recommendations for lumbopelvic pain associated with pregnancy.
These contents will be developed by midwives from the participating hospitals.
Participants will receive 12 educational sessions, with an estimated duration of 10 minutes each.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fear of childbirth
Time Frame: 4 weeks
|
The Wijma Delivery Expectancy Questionnaire (W-DEQ) version A, validated in Spanish, has shown excellent psychometric properties.
This instrument consists of 33 items scored from 1 to 6, with higher scores indicating greater fear of childbirth.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain catastrophizing
Time Frame: 4 weeks
|
The pain catastrophizing scale is an instrument made up of 13 items (each item scores between 0 and 4), which measures the degree to which patients develop feelings and thoughts related to their nociceptive experience.
This scale, which has a validated version for Spanish, shows adequate internal consistency.
|
4 weeks
|
|
Anxiety and depression
Time Frame: 4 weeks
|
The Hospital Anxiety and Depression Scale (HADS) questionnaire will be used.
This consists of 14 questions, of which 7 assess symptoms of anxiety (HADS-A) and 7 measure symptoms of depression (HADS-D).
Each item scores from 0 to 3, with a score range in each subscale from 0-21.
Scores of 0-7 indicate no anxiety or depression; scores between 8-10 indicate medium levels; scores of 11-14 indicate moderate levels and scores of 15-21 indicate severe levels of anxiety or depression.
The HADS scale has good internal consistency, reliability, and validity.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNIVERSITY CARDENAL HERRERA-71
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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