Virtual Reality Device for Pain and Anxiety Management During Labor
Virtual Reality Hypnosis for Labor Pain and Anxiety Management
Agnosia+8
+ Anxiety Disorders
+ Mental Disorders
Supportive Care Study
Summary
Study start date: May 1, 2025
Actual date on which the first participant was enrolled.This study is exploring the use of a virtual reality hypnosis device called HypnoVR to help manage pain and anxiety for women during childbirth. It focuses on women who are in the early and active stages of labor and aims to see if this technology can offer relief without using medication. The study is important as it could provide a new way to support women during labor, potentially making the experience less stressful and painful by using VR technology, which is a non-drug approach. Participants in the study are divided into two groups. One group uses the HypnoVR device, which they experience through virtual reality, while the other group receives the usual care given during labor. The study measures how effective HypnoVR is by looking at changes in pain and anxiety levels using specific scales before and after the intervention. It also checks other factors such as the mother's heart rate and blood pressure, the frequency and strength of contractions, the baby's heart rate, and how satisfied the mothers feel after the birth. This approach ensures a thorough understanding of how HypnoVR might impact the labor process and overall experience.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.70 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for inclusion in the study: * Female participants aged between 18 and 45 years * Primiparous or multiparous * Singleton pregnancy * Cephalic (vertex) presentation * Gestational age between 37 and 41 completed weeks * Admitted in spontaneous (uninduced) labor * Low-risk pregnancy with no obstetric complications (e.g., no preeclampsia, gestational diabetes, or intrauterine growth restriction) * Spontaneous and uneventful course of pregnancy * At least four documented prenatal care visits during pregnancy * Expressed desire for vaginal delivery * Provided written informed consent to participate in the study Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria: * History of any psychiatric disorder (e.g., anxiety, depression, bipolar disorder, psychosis, delirium) organic brain disease, or cognitive/developmental disorders) * History of seizures or epilepsy * Any degree of hearing impairment * Any visual impairment * History of face, neck, or head injuries that may interfere with the use of virtual reality equipment * History of motion sickness or vestibular disorders (e.g., dizziness, vertigo) * Chronic pain conditions or frequent migraines * History of claustrophobia * High-risk pregnancy (e.g., fetal growth restriction, placenta previa, or other significant maternal-fetal complications) * Known fetal anomalies or placental abnormalities * Labor pain not attributed to uterine contractions * Induced labor (medically or pharmacologically initiated)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location