Fear of ChildbirthNCT07471269
Online Pain Neuroscience Education For Fear Of Childbirth.
A study testing Pain neuroscience education and Prenatal education in people with Fear of Childbirth, run by Cardenal Herrera University at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth
- What is being tested?
- Pain neuroscience education and Prenatal education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 26 Mar 2026to 26 Sep 2026
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women over 18 years of age, primiparous or multiparous.
- At the beginning of the third trimester of pregnancy
Who cannot join
- Multiple pregnancies.
- Previous spinal surgery.
- Psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Fear of Childbirth
- Being tested
- Pain neuroscience education, Prenatal education
- Keywords
- fear of childbirth, pregnancy, pain neuroscience education, prenatal education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience educationOther
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.
Prenatal educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pain neuroscience education; Other: 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. Receives: Other: Prenatal education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start26 Mar 2026
- Primary completion26 Sep 2026
- Study completion26 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of ChildbirthStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471269
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA-71
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of An Online Pain Neuroscience Education Intervention In Reducing Fear Of Childbirth Among Pregnant Women.
- ClinicalTrials.gov ID
- NCT07471269
- Acronym / sponsor ID
- UNIVERSITY CARDENAL HERRERA-71
- Conditions
- Fear of Childbirth
- Keywords
- fear of childbirth, pregnancy, pain neuroscience education, prenatal education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 26 Sep 2026 (actual)
- Study completion
- 26 Sep 2026 (actual)
- First posted
- 13 Mar 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain neuroscience education (PNE) | Experimental | Other: Pain neuroscience education, Other: Prenatal educationThe 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. |
| Prenatal education (PE) | Experimental | Other: Prenatal educationPatients 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women over 18 years of age, primiparous or multiparous.
- At the beginning of the third trimester of pregnancy
Key exclusion criteria (3 listed)
- Multiple pregnancies.
- Previous spinal surgery.
- Psychiatric disorders.
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 educationThe 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. | Other | Pain neuroscience education (PNE) |
| Prenatal educationThe 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. | Other | Pain neuroscience education (PNE), Prenatal education (PE) |
Primary outcome
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.
2 secondary outcomes
Pain catastrophizing
Time frame: 4 weeks
Anxiety and depression
Time frame: 4 weeks
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 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Fear of Childbirth
Not yet recruiting
Coloring Activity Applied During Labor in Primiparous Pregnant Women and Its Effect on Birth Anxiety and Fear of Childbirth
Fear of Childbirth, Mandala Coloring
Enrolling by invitation
The Effect of Podcast Training on Birth Fear in Couples
Pregnancy, Birth Fear
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruiting
Mindfulness Psychoeducation Based on Transtheoretical Model for Fear of Childbirth
Fear of Childbirth, Pregnancy
Recruiting
Virtual Reality-Enabled Digital Storytelling
Primiparous Pregnant Women
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Prenatal education in people with Fear of Childbirth, run by Cardenal Herrera University at 1 site in Spain.
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 2 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 26 Oct 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 Spain. 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?
Fear of childbirth (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.