[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658027":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":27,"studyPopulation":18,"armGroups":28,"interventions":41,"overallOfficials":18,"centralContacts":50,"locations":18,"responsibleParty":56,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":44,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":84,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":18},{"fullName":5,"class":6},"Fundación de investigación HM","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Fear of Childbirth Assessed Using the Wijma Delivery Expectancy\u002FExperience Questionnaire (W-DEQ)","The Wijma Delivery Expectancy\u002FExperience Questionnaire (W-DEQ) will be used to assess fear of childbirth. The W-DEQ-A will be administered during pregnancy, before the intervention, to assess anticipatory fear of childbirth, while the W-DEQ-B will be administered after childbirth to assess the emotional experience of giving birth.\n\nEach version consists of 33 items scored on a 6-point Likert scale (0-5), with a total score ranging from 0 to 165. Higher scores indicate greater fear of childbirth or a more negative childbirth experience. Positively worded items are reverse-scored before calculating the total score.\n\nW-DEQ scores will be compared between the Gestaverso intervention group and the usual childbirth preparation group.","During pregnancy, before the intervention (baseline), and after childbirth (postpartum assessment), approximately 6-8 weeks from baseline.",[14],{"measure":15,"description":16,"timeFrame":17},"Childbirth Experience Assessed Using the Childbirth Experience Questionnaire (CEQ-E)","Childbirth experience will be assessed using the Spanish version of the Childbirth Experience Questionnaire (CEQ-E), a validated patient-reported experience measure consisting of 22 items across four domains: own capacity (8 items), professional support (5 items), perceived safety (6 items), and participation (3 items).\n\nNineteen items are scored using a 4-point Likert scale, while three items use a visual analogue scale subsequently converted into four categories. Higher scores indicate a more positive childbirth experience.\n\nChildbirth experience scores will be compared between the Gestaverso intervention group and the usual childbirth preparation group.","After childbirth, during the postpartum assessment (approximately 6-8 weeks from baseline).",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":24,"maskingDescription":18,"whoMasked":25},"SINGLE",[26],"OUTCOMES_ASSESSOR","A previous negative childbirth experience may contribute to increased fear and anxiety during subsequent pregnancies. Women who have experienced a distressing or traumatic birth may develop negative expectations about future childbirth, potentially affecting their emotional well-being and confidence in their ability to cope with labor.\n\nConventional childbirth preparation programs provide information about pregnancy, labor, pain management, and coping strategies. However, women with previous negative birth experiences may benefit from additional approaches that address the emotional aspects of childbirth and help them become familiar with the birth environment in a safe and controlled setting.\n\nVirtual reality (VR) offers an immersive educational experience that allows pregnant women to become familiar with different stages of labor, practice coping strategies, and develop confidence in managing childbirth-related situations. Although VR has been investigated for pain and anxiety management during labor, its potential as a prenatal preparation tool specifically for women with previous negative childbirth experiences remains insufficiently explored.\n\nGestaverso is an immersive VR-based childbirth preparation program designed to simulate the childbirth journey, from the onset of labor at home to hospital admission, labor progression, and birth. The program combines visual, auditory, tactile, and sensory stimuli with professional guidance from a trained midwife.\n\nThis multicenter, randomized controlled trial will compare Gestaverso with usual childbirth preparation provided by midwives. Participants will be randomly allocated to two parallel groups in a 1:1 ratio.\n\nThe Gestaverso intervention consists of one individualized 60-minute session, including a 10-minute briefing, approximately 40 minutes of immersive VR simulation, and a 10-minute debriefing. The experience is guided by a midwife certified in Gestaverso training and adapted to the participant's individual needs.\n\nDuring the simulation, participants will experience different childbirth scenarios, including the onset and progression of contractions at home, the transition to the hospital, admission procedures, and the different stages of labor. They will practice breathing, relaxation, movement, pain management strategies, and communication with healthcare professionals. The birth partner will also be involved in learning supportive techniques.\n\nThe control group will receive usual childbirth preparation delivered by midwives through group-based educational sessions, either in person or online. These sessions address third-trimester symptoms, signs of labor, types of birth, contraction management, breathing techniques, and pelvic movement.\n\nThe study will be conducted at three hospitals in Spain: HM Puerta del Sur, HM Nuevo Belén, and HM Montepríncipe.\n\nThe study aims to determine whether Gestaverso can reduce fear of childbirth and improve the childbirth experience compared with usual childbirth preparation in women with previous negative birth experiences. It will also explore participants' satisfaction with and acceptance of virtual reality as a childbirth preparation tool.",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"Gestaverso Virtual Reality Childbirth Preparation","EXPERIMENTAL","Participants assigned to this arm will receive an individualized 60-minute childbirth preparation session using Gestaverso, an immersive virtual reality program guided by a certified midwife. The session consists of a 10-minute briefing, approximately 40 minutes of immersive simulation, and a 10-minute debriefing. The simulation recreates the childbirth journey, from the onset of labor at home to hospital admission, labor progression, and birth. Participants will practice breathing, relaxation, pelvic movement, non-pharmacological pain management strategies, and communication with healthcare professionals. Their birth partner will also participate in the experience and learn techniques to provide physical and emotional support during labor.",[34],"Behavioral: Gestaverso",{"label":36,"type":37,"description":38,"interventionNames":39},"Usual Childbirth Preparation","ACTIVE_COMPARATOR","Participants assigned to this arm will receive usual childbirth preparation provided by midwives through group-based educational sessions, either in person or online, according to their preferences. The program consists of approximately 3 to 4 hours of education covering third-trimester symptoms, signs of labor, types of birth, contraction management, breathing techniques, and pelvic movement. Educational materials, recorded sessions, and support for questions will be available when needed. Participants will not receive virtual reality-based childbirth preparation.",[40],"Behavioral: Control group",[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":18},"BEHAVIORAL","Gestaverso","Virtual Reality-Based Childbirth Preparation (Gestaverso)",[30],{"type":43,"name":48,"description":48,"armGroupLabels":49,"otherNames":18},"Control group",[36],[51],{"name":52,"role":53,"phone":54,"phoneExt":18,"email":55},"Cayetana Ruiz Zaldibar, PhD","CONTACT","695829472","crzaldibar@ucjc.edu",{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100658027","effectiveness-of-gestaverso-virtual-reality-birth-preparation-in-women-with-previous-negative-birth-experiences-100658027",false,"NCT07846306","Effectiveness of Gestaverso Virtual Reality Birth Preparation in Women With Previous Negative Birth Experiences","Effectiveness of Gestaverso Versus Usual Childbirth Preparation in Pregnant Women With Previous Negative Birth Experiences: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Pregnant women aged 18 years or older.\n* Pregnant women at or beyond 32 weeks of gestation.\n* Having experienced at least one previous childbirth.\n* Reporting a previous negative childbirth experience, defined by an affirmative response to the question: \"Was there any moment during your previous childbirth that you found distressing or traumatic?\"\n* Ability to read and understand the language in which the childbirth preparation program is delivered.\n* Willingness to participate voluntarily and provide written informed consent.\n\nExclusion Criteria:\n\n* Women who have never given birth before (primiparous women).\n* Previous psychiatric diagnosis or anxiety disorder requiring active treatment.\n* Multiple pregnancies, high-risk pregnancies, or obstetric complications that may limit participation.\n* Cognitive or sensory impairments that prevent the use of virtual reality.","FEMALE","18 Years",{"count":68,"type":69},124,"ESTIMATED","INTERVENTIONAL",[72],"NA","A previous negative childbirth experience can increase fear and anxiety about giving birth again. This study aims to determine whether Gestaverso, a virtual reality-based childbirth preparation program, can help reduce fear of childbirth and improve the birth experience in pregnant women who have previously experienced a negative birth.\n\nThe study will include 124 pregnant women who have given birth at least once before and report a previous negative childbirth experience. Participants will be randomly assigned to one of two groups.\n\nOne group will receive an individualized childbirth preparation session using Gestaverso, a virtual reality program guided by a trained midwife. During the approximately 60-minute session, participants will experience a simulated childbirth journey, practice breathing and relaxation techniques, learn strategies for managing contractions, and become familiar with the hospital environment and different stages of labor. Their birth partner will also be encouraged to participate.\n\nThe other group will receive usual childbirth preparation provided by midwives, without virtual reality.\n\nParticipants will complete questionnaires about their fear of childbirth before the intervention and their childbirth experience after giving birth. The researchers will compare the results between the two groups to assess whether virtual reality-based childbirth preparation may help women with previous negative birth experiences feel more prepared for childbirth and have a more positive birth experience.",[75,76],"Fear of Childbirth","Childbirth-Related Anxiety",[44,78,79,75,76,80,81,82,83],"Virtual Reality","Childbirth Preparation","Negative Birth Experience","Traumatic Childbirth","Prenatal Education","Childbirth Experience","NOT_YET_RECRUITING","2026-09-23",{"date":87,"type":88},"2026-09-29","ACTUAL",{"date":90,"type":69},"2026-11-01",{"date":92,"type":69},"2027-07",{"name":5,"class":6}]