NCT07471269

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

March 26, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2026

Last Updated

April 15, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 10, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

fear of childbirthpregnancypain neuroscience educationprenatal education

Outcome Measures

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.

    4 weeks

Secondary Outcomes (2)

  • Pain catastrophizing

    4 weeks

  • Anxiety and depression

    4 weeks

Study Arms (2)

Pain neuroscience education (PNE)

EXPERIMENTAL

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 educationOther: Prenatal education

Prenatal education (PE)

EXPERIMENTAL

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

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.

Pain neuroscience education (PNE)Prenatal education (PE)

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.

Pain neuroscience education (PNE)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Cardenal Herrera

Alfara del Patriarca, Valencia, 46115, Spain

RECRUITING

MeSH Terms

Interventions

Prenatal Education

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

March 26, 2026

Primary Completion (Estimated)

September 26, 2026

Study Completion (Estimated)

September 26, 2026

Last Updated

April 15, 2026

Record last verified: 2026-03

Locations