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临床试验/NCT07471269
NCT07471269招募中不适用

Effectiveness Of An Online Pain Neuroscience Education Intervention In Reducing Fear Of Childbirth Among Pregnant Women.

Cardenal Herrera University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年3月26日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Fear of childbirth

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Pain neuroscience education (Other)

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.

干预措施: Prenatal education (Other)

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.

干预措施: Prenatal education (Other)

结局指标

主要结局

Fear of childbirth

时间窗: 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.

次要结局

  • Pain catastrophizing(4 weeks)
  • Anxiety and depression(4 weeks)

研究者

发起方
Cardenal Herrera University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan F. Lisón Párraga, Dr

Professor

Cardenal Herrera University

研究点 (1)

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