Clinical Trials Logo

Clinical Trial Summary

Childbirth is associated with labour pain and can be regarded as one of the most serious kinds of pain. Labour pain management methods include pharmacological and non-pharmacological methods. There is increasing evidence that virtual reality (VR) is effective in the reduction of pain. The implementation of alternative methods like VR to reduce labour pain can contribute to reduce the use of pharmacological pain management methods and associated side effects. The objective of this study is to asses the effect of VR on the request for labour analgesia compared with standard care. Secondary objectives are the effect of VR on; the referral rate from midwifery led first line care to second line obstetrical care, patient satisfaction of VR use, delivery expectancy and experience (WIDEQ-A and WIDEQ-B), patient reported outcome measures (PROMs) and patient reported experience measure (PREMs) as defined by international consortium for health outcome measures (ICHOM) and evaluate the social, economic, organizational and ethical issues of VR by using the health-technology assessment analysis (HTA). Study design: The study concerns a non-blinded, single centre, randomised controlled trial Study population: Nulliparous and multiparous women with a singleton in cephalic presentation beyond 36+0 weeks' gestation and an intention for vaginal delivery. The study population will be randomly assigned to the intervention group (VR-group) or the care as usual group. The intervention group will be exposed to an immersive guided relaxation VR experience (BirthVR) during labour. If a woman in the intervention group requires additional pharmacological pain relief, this will be offered according to the local protocol. The participants who are randomised to the standard care group receive labour pain analgesia on maternal request according to the local usual standard care.


Clinical Trial Description

The study concerns a non-blinded single centre, randomised controlled trial (RCT). Eligible patients will be randomised to either the VR group or standard care group. In addition to the standard care, the VR group receives a VR information moment during labour and the possibility to exercise with the VR glasses and they receive VR during labour from the moment they are in active labour and use VR as much as they prefer. Patients randomised to the care as usual group will be offered pain medication during labour according to the local protocol, and on maternal request only. Women in first line care will be informed and counseled by their own midwife during their 34 weeks checkup. Informed consent will be signed during their next checkup with 36 weeks. The patient will receive a study number together with their randomization group, during their next checkup the VR information video will be offered to women participating in the VR group. Women under hospital care during their pregnancy will be informed and counseled by their care giver in the Zuyderland MC during their 34 weeks checkup. At 36 weeks informed consent will be signed. Patients will then receive a study number together with their randomization group and during their next checkup the VR information video will be offered to women in the VR group. Data will be collected during labour about VR. The following data will be collected; number of times VR is used during labour, number of minutes per VR session, dilatation and amount of contraction per 10 minutes when using VR for the first time and the way in which labour started. After informed consent participating women will be randomly assigned the intervention group (VR group) or the care as usual group. Counseling will take place around 34 weeks of pregnancy. At 36 weeks of pregnancy randomization will be done by the data manager program. Stratified randomisation will be done to create equal groups concerning primiparous and multiparous women. After informed consent is obtained the women will be asked to fill in the ICHOM T2 questionnaire, a baseline questionnaire and the WDEQ-A questionnaire. After labour, participants of the VR-group receive a structured questionnaire in which tolerability, feasibility and satisfaction of VR use is evaluated and participants receive the WDEQ-B questionnaire and PROM and PREM (ICHOM; T3, T4, T5). Postpartum participants of the care as usual group receive the WDEQ-B questionnaire and PROM and PREM (ICHOM; T3, T4, T5). The study will be conducted in the Zuyderland Medical Center, location Heerlen and in first line midwifery practices (Verloskundig samenwerkings verband Zuyderland; VSV). Subjects can withdraw from participating at any time for any reason without consequences. The investigator can decide tot withdraw a subject from the study for urgent medical reasons. After withdrawal of a participant, it is not possible to replace this participant with a new participant. After withdrawal of a participant, the patient is asked to agree using the data from the medical file. The hypothesis is that BirthVR will result in a 15% decrease in the request for labour analgesia. Assuming a decrease of 15%, power of 80% and a type I error of 0.05, a total of 338 women must be included, of which 169 women in the BirthVR group and 169 women in the 'care-as-usual' group. Taking into account a loss to follow-up of 10%, 186 women will have to be included per study and a total of 372 women. It is expected to include 279 women in second line obstetrical care. The investigators expect to include 93 patients in first line midwifery care. The data of both groups will be analysed using SPSS (version 27). A table with baseline characteristics will be compiled using the Mann-Whitney-U test. A Chi-square test will be used to answer our primary objective. If, after randomization, it appears that the groups still differ regarding certain (baseline) variables, possible confounders will be assessed using a multivariable linear regression analysis. A p-value of <0.05 will be considered statistically significant. Tolerability, feasibility and patient satisfaction of VR use will be assessed using the answers to the BirthVR questionnaire, WDEQ and ICHOM questionnaires, using mostly descriptive analyses. Missing values will be excluded or imputed depending on the number of missing values. If the missing data is less than 10% pairwise deletion will be used. If a participant is excluded or withdraws participation after being included but before even using VR, there will be a new participant included (1:1). A loss to follow-up of 10-20% will be corrected by a multiple imputation (SPSS). If the loss to follow-up is >20% the number of missing participants have to be included to protect the internal validity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04992663
Study type Interventional
Source Zuyderland Medisch Centrum
Contact Anne-Claire Musters, M.D.
Phone 088-4597777
Email a.musters@zuyderland.nl
Status Recruiting
Phase N/A
Start date June 17, 2021
Completion date September 1, 2023

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