Use of Virtual Reality in Active Labor

Status Not yet recruiting

Clinical Trial Summary

Clinical Trial Description

Labor is widely recognized as one of the most painful experience possible. The standard analgesic treatment currently consists of pharmacological methods. Adverse effects, complication risks, psychological effects, limit these techniques as well as high costs. These limits concurred to the application of these techniques mainly on demand and not routinely. For all these reasons, it is not surprising the interest in offering women valid non-invasive and cheaper options to relieve them from pain. As of today many alternative techniques have been proposed, many of which have not, as of today, met a large scientific consensus, as shown by many recent Cochrane reviews. A promising perspective for non-pharmacological analgesia seems to be offered by Virtual Reality (VR) devices, which have been applied to many different medical areas. Recently Frey et al. have experimented in a pilot study the application of this technique to women during labor, obtaining interesting results. The authors of this study point, in the discussion of the scientific paper, to the necessity of developing virtual reality experiences more specific to labor and suggest different implementations, such as specific instructions for women (changes of position, breathing techniques) greater comfort (it is worth noticing the use on our side of exclusively wireless devices) and the implementation of the device with biofeedback. In addition to learning from these suggestions, we tried to imagine VR in a different way: firstly as complementary, not alternative to the role of the midwife personnel, who will play a central role in our experimental treatment enriching the virtual reality scenario with their instructions, presence and motivational feedback; secondly we tried to imagine VR as a guide through labor, more than a alienation and distraction tool. ;

Study Design

Related Conditions & MeSH terms

Labor Pain

Clinical Trial Details

NCT number	NCT04862039
Study type	Interventional
Source	Federico II University
Contact
Status	Not yet recruiting
Phase	N/A
Start date	May 1, 2021
Completion date	October 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03539562` - Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
Withdrawn	`NCT04662450` - Evaluation and Management of Parturients' Pain Intensity	N/A
Completed	`NCT02885350` - Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour	Phase 4
Completed	`NCT02550262` - Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor	N/A
Completed	`NCT01598506` - Intrathecal Hydromorphone for Labor Analgesia	Phase 2
Withdrawn	`NCT01636999` - Comparing Sedara to Butorphanol in Early Labor	N/A
Completed	`NCT00987441` - Epidural Labor Analgesia and Infant Neurobehavior	N/A
Completed	`NCT00755092` - Effect of Doula in Nulliparas and Multiparas	N/A
Terminated	`NCT00787176` - The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes	N/A
Recruiting	`NCT06036797` - Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia	Phase 2
Completed	`NCT05512065` - Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women	N/A
Completed	`NCT05327088` - Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia	Phase 2
Completed	`NCT03103100` - Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation	Phase 3
Recruiting	`NCT03623256` - Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia	Phase 4
Active, not recruiting	`NCT02271100` - Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique	N/A
Completed	`NCT02926469` - Virtual Reality Analgesia in Labor: The VRAIL Pilot Study	N/A
Completed	`NCT03712735` - Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women	Phase 4
Not yet recruiting	`NCT05565274` - Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients	N/A
Recruiting	`NCT02575677` - Oxycodone in Treatment of Early Labour Pain Efficacy and Safety
Recruiting	`NCT01708668` - The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.