Virtual RealityDELIVRNCT04992663
Investigating the Effect of Virtual Reality on Labour Analgesia Use
A study of Virtual Reality and Labor Pain, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Labor Pain, Labor Analgesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Jun 2021to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written and orally given informed consent
- 18 years and older
- Native Dutch speaker
- Singleton pregnancy
- Nulliparous or multiparous women
- cephalic presentation
Show all 9Show fewer
- 36+0 weeks gestation
- Intention for a vaginal delivery
- Under care of Zuyderland hospital or one of the first line midwifery practices participating in the Verloskundig Samenwerkings Verband (VSV) Zuyderland
Who cannot join
- Chronic pain patients defined as 'persistent or recurrent pain lasting longer than 3 months. The pain is not due to an obstetrical problem.
- Chronic use of pain medication (opioids)
- Alcohol or drug abuse
- Known car sickness
- Epileptic insults in previous history
- Psychotically seizures in previous history
Show all 12Show fewer
- Claustrophobic
- Visual impairment
- History of mental illness
- Patients in strict isolation (MSRA)
- Age <18 years
- Twin pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Zuyderland MC
Heerlen, Limburg, 6401 CX
Anne-Claire Musters, M.D., 088-4597777, a.musters@zuyderland.nl
Martine Wassen, M.D., m.wassen@zuyderland.nl
About this study
Official title: DELIVR: A Multicenter Randomised Controlled Trial Investigating the Effect of Virtual Reality on Labour Analgesia Use
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.
Read more
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.
Read the detailed 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.
- Conditions
- Virtual Reality, Labor Pain, Labor Analgesia
- Being tested
- PICO glasses and controller with BirthVR
- Keywords
- Virtual Reality, Analgesia, Labor Pain
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO glasses and controller with BirthVRDevice
PICO glasses will be used for VR in the intervention group. BirthVR is a guided meditation VR application designed by qualitative research (VIREL study) performed by this study group.
The BirthVR application contains the following components:
- Information/introduction video (including a virtual reality tour through the labour ward of the Zuyderland MC)
- Fase 1: Beach environment, guided meditation/breathing exercise (1 session: 25 minutes)
- Fase 2: Underwater environment, guided meditation/breathing exercise (1 session: 25minutes)
- Fase 3: Mountain environment, breathing technique exercise on demand by using the controller (1 session: 30 minutes)
- Counseling video (cesarean section, epidural anesthesia)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (VR-group) | Experimental | The participants randomised into this group are offered the BirthVR intervention during Labour.
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. 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).
As soon as VR does not serve as adequate pain relief during labour and a women requests additional pain medication this will be offered according to local protocol. Receives: Device: PICO glasses and controller with BirthVR |
| Care as usual group | No intervention | 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. Postpartum participants receive the WDEQ-B questionnaire and PROM and PREM (ICHOM; T3, T4, T5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of request for pharmacological analgesia by women in labour
Any pharmacological analgesia received during labour? Yes or no.
Measured: From the start of labour (contraction or spontaneous rupture of membranes) until start pushing (expulsion phase)
Secondary outcomes (5)
The referral rate from midwifery led first line care to second line obstetrical care based on pharmacological analgesia request during labour
Examine the referrals from midwifery led first line care to second line obstetrical care because of a wish for pain rmedication during labour.
Measured: From the start of labour (contraction or spontaneous rupture of membranes) until start pushing (expulsion phase)
Delivery expectancy and experience (WDEQ-A and WDEQ-B)
The WDEQ is a 33-item, 6-point Likert scale questionnaire. Items refer to expectations and experiences before and after birth, each scoring from 0 to 6. Women have to answer while imagining how labour and delivery are going to be, and how they expect to feel. Items with positively formulated questions are reverse-scored. The sum score ranges from 0 to 165; the higher the score is, the greater the fear of childbirth.
Measured: WDEQ-A (at 36week pregnancy), WDEQ-B (1-7 days post partum)
Patient satisfaction of VR use and the application BirthVR (questionnaire)
A patients' VR experience and satisfaction was examined using a post-intervention questionnaire.
A short post intervention questionnaire (7 questions), intended to provide feedback about the experience and preference of the BirthVR application the patient used during labour. Ratings varied of very pleasant (+5) versus very unpleasant (0) and very much (+5) versus not at all (0).
Theme's: General experience, reusing BirthVR, preference of environment, side effects.
Measured: 1-7 days post partum
Patient reported outcome measures (PROMs) as defined by ICHOM
Outpatient clinic (AD 36 weeks) - Capture of patient reported outcomes according to timepoint T2 of the Dutch version of the ICHOM standard outcome set Pregnancy and Childbirth
T1 = within 7 days postpartum
- Capture of patient-reported outcomes according to timepoint T3 of the Dutch version of the ICHOM standard outcome set Pregnancy and Childbirth
T2= 6 weeks postpartum - Capture of patient-reported outcomes according to timepoint T4 of the Dutch version of the ICHOM standard outcome set Pregnancy and Childbirth
T3= 6 months postpartum
- Capture of patient-reported outcomes according to timepoint T5 of the Dutch version of the ICHOM standard outcome set Pregnancy and Childbirth
Measured: AD 36weeks, 1-7 days post partum, 6 weeks post partum and 6 months post partum
Patient reported experience measure (PREMs) as defined by ICHOM
Outpatient clinic (AD 36 weeks) - Capture of patient reported experiences according to timepoint T2 of the Dutch version of the ICHOM standard outcome set Pregnancy and Childbirth
T1 = within 7 days postpartum
- Capture of patient-reported experiences according to timepoint T3 of the Dutch version of the ICHOM standard outcome set Pregnancy and Childbirth
T2= 6 weeks postpartum - Capture of patient-reported experiences according to timepoint T4 of the Dutch version of the ICHOM standard outcome set Pregnancy and Childbirth
T3= 6 months postpartum
- Capture of patient-reported experiences according to timepoint T5 of the Dutch version of the ICHOM standard outcome set Pregnancy and Childbirth
Measured: AD 36weeks, 1-7 days post partum, 6 weeks post partum and 6 months post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start17 Jun 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-blinded, starting as single centre, randomised controlled trial (RCT). After implementation of the DELIVR trial in the Zuyderland MC, the study will be expanded as a multi centre trial.
- Masking
- None (open label)
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- Diakonessenhuis, Utrecht
- Responsible party
- Sponsor
- Investigators
- Martine Wassen, M.D., Principal investigator, Zuyderland MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992663
- Sponsor's protocol ID
- METCZ20210037
- Acronym
- DELIVR
- Status last verified
- Jul 2021
- First submitted
- 17 Jun 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DELIVR: A Multicenter Randomised Controlled Trial Investigating the Effect of Virtual Reality on Labour Analgesia Use
- ClinicalTrials.gov ID
- NCT04992663
- Acronym / sponsor ID
- DELIVR / METCZ20210037
- Conditions
- Virtual Reality, Labor Pain, Labor Analgesia
- Keywords
- Virtual Reality, Analgesia, Labor Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Collaborators
- Diakonessenhuis, Utrecht
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-blinded, starting as single centre, randomised controlled trial (RCT). After implementation of the DELIVR trial in the Zuyderland MC, the study will be expanded as a multi centre trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (VR-group) | Experimental | Device: PICO glasses and controller with BirthVRThe participants randomised into this group are offered the BirthVR intervention during Labour. 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. 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). As soon as VR does not serve as adequate pain relief during labour and a women requests additional pain medication this will be offered according to local protocol. |
| Care as usual group | No intervention | –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. Postpartum participants receive the WDEQ-B questionnaire and PROM and PREM (ICHOM; T3, T4, T5) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written and orally given informed consent
- 18 years and older
- Native Dutch speaker
- Singleton pregnancy
- Nulliparous or multiparous women
Key exclusion criteria (12 listed)
- Chronic pain patients defined as 'persistent or recurrent pain lasting longer than 3 months. The pain is not due to an obstetrical problem.
- Chronic use of pain medication (opioids)
- Alcohol or drug abuse
- Known car sickness
- Epileptic insults in previous history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICO glasses and controller with BirthVRPICO glasses will be used for VR in the intervention group. BirthVR is a guided meditation VR application designed by qualitative research (VIREL study) performed by this study group. The BirthVR application contains the following components: * Information/introduction video (including a virtual reality tour through the labour ward of the Zuyderland MC) * Fase 1: Beach environment, guided meditation/breathing exercise (1 session: 25 minutes) * Fase 2: Underwater environment, guided meditation/breathing exercise (1 session: 25minutes) * Fase 3: Mountain environment, breathing technique exercise on demand by using the controller (1 session: 30 minutes) * Counseling video (cesarean section, epidural anesthesia) | Device | Intervention group (VR-group) |
Primary outcome
Change of request for pharmacological analgesia by women in labour
Time frame: From the start of labour (contraction or spontaneous rupture of membranes) until start pushing (expulsion phase)
Any pharmacological analgesia received during labour? Yes or no.
5 secondary outcomes
The referral rate from midwifery led first line care to second line obstetrical care based on pharmacological analgesia request during labour
Time frame: From the start of labour (contraction or spontaneous rupture of membranes) until start pushing (expulsion phase)
Delivery expectancy and experience (WDEQ-A and WDEQ-B)
Time frame: WDEQ-A (at 36week pregnancy), WDEQ-B (1-7 days post partum)
Patient satisfaction of VR use and the application BirthVR (questionnaire)
Time frame: 1-7 days post partum
Patient reported outcome measures (PROMs) as defined by ICHOM
Time frame: AD 36weeks, 1-7 days post partum, 6 weeks post partum and 6 months post partum
Patient reported experience measure (PREMs) as defined by ICHOM
Time frame: AD 36weeks, 1-7 days post partum, 6 weeks post partum and 6 months post partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Virtual Reality
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Not yet recruiting
Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses
Stroke, Upper Extremity Paresis
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Wassen, M.D. principal investigator
Zuyderland MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Virtual Reality and Labor Pain, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Claire Musters, M.D. (088-4597777, a.musters@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of request for pharmacological analgesia by women in labour (time frame: From the start of labour (contraction or spontaneous rupture of membranes) until start pushing (expulsion phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.