ClinicalTrials.gg
CompletedNCT07471269Updated Oct 26, 2026

Online Pain Neuroscience Education For Fear Of Childbirth.

An interventional study of Pain neuroscience education and Prenatal education in Fear of Childbirth, sponsored by Cardenal Herrera University. Completed at 1 site in Spain. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Treatment

Updated Oct 26, 2026Now CompletedEnrollment updatedGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Fear of Childbirth

Keywords

  • fear of childbirth
  • pregnancy
  • pain neuroscience education
  • prenatal education
03

In context

Lead sponsor

Cardenal Herrera University is the lead sponsor of 108 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant women over 18 years of age, primiparous or multiparous.
  • At the beginning of the third trimester of pregnancy

Exclusion criteria

Exclusion Criteria:

  • Multiple pregnancies.
  • Previous spinal surgery.
  • Psychiatric disorders.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
400 participants (actual)

Study arms

  • 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.

    Other: Pain neuroscience education · Other: Prenatal education

  • 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.

    Other: Prenatal education

Interventions

  • OtherPain neuroscience education

    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.

  • OtherPrenatal education

    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.

06

What researchers measure

Primary outcomes

  1. Fear of childbirth

    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.

    Time frame: 4 weeks

Secondary outcomes

  1. Pain catastrophizing

    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.

    Time frame: 4 weeks

  2. Anxiety and depression

    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.

    Time frame: 4 weeks

07

Study locations

1 site
  • University Cardenal Herrera
    Alfara del Patriarca, Valencia 46115, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2026 to primary completion in Sep 2026, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2026
First posted
Mar 13, 2026
StartActual
Mar 26, 2026
Primary completionActual
Sep 26, 2026
CompletionActual
Sep 26, 2026
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Recruiting→Completed
    + 4 other changes: verification date, date precision, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07471269
Responsible party
Juan F. Lisón Párraga, Dr (Professor, Cardenal Herrera University) — Principal investigator
First posted
Mar 13, 2026
Start date
Mar 26, 2026
Primary completion
Sep 26, 2026
Completion
Sep 26, 2026
Last update
Oct 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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