Labor PainNCT05032456
Immersive Virtual Reality Satisfies the Women in Labor by Distracting Them From Their Labor Pain in Labor on Latent and Active Phase
A study testing Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system in people with Labor Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
This is a randomized control study with 42 laboring women allocated to virtual reality intervention and control groups. The objective of this study, to evaluate the effectiveness of immersive virtual reality in laboring women on patient satisfaction and pain relief. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2020to 14 Jun 2021
- 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 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-42 years of age
- 37-41 week gestation
- A singleton pregnancy
- With vertex presentation
- No history of chronic medical conditions
- Absence of pregnancy complications
- Admission with documented labor by cervical exam and regular uterine contractions.
Who cannot join
- Migraine
- Headache
- Dizziness
- Motion Sickness
- Epilepsy
- Psychiatric disorders
- Visual or auditory disabilities
- History of cesarean section
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Maslak Hospital
Istanbul, Sariyer, 34457
About this study
Official title: Immersive Virtual Reality Improves Satisfaction In Laboring Women
This is a randomized control study with 42 laboring women allocated to virtual reality intervention and control groups. The objective of this study, to evaluate the effectiveness of immersive virtual reality in laboring women on patient satisfaction and pain relief. The satisfaction of patients was measured with a "Virtual reality satisfaction survey" which was prepared by the investigators. Pain levels were assessed by a virtual pain rating scale in the early and the active phase of labor in both groups.
Read the detailed description
Labor is a long and painful process for women. For avoiding or alleviating pain, adjuvant treatments such as hydrotherapy, yoga, hypnosis, acupuncture, and relaxation techniques could be used. Recent literature indicates the successful use of immersive virtual reality for a variety of painful medical procedures. Immersive virtual reality is hypothesized to reduce pain through distraction, a non-pharmacologic attentional mechanism. The user's brain is preoccupied with the flood of information presented by the virtual environment restricting the mind from processing pain signals. The investigators hypothesized that laboring women find immersive virtual reality as a beneficial tool for their overall labor and delivery experience. The 42 laboring women were randomized into two arms: virtual reality group ( intervention group) and control group. The investigators used Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system. Before the intervention, the authors introduced the equipment and instructed study participants on how to wear and activate the headsets. Anxiety and depression scales were also applied on admission. The laboring women who enrolled in the VR group first wore the headsets in early labor (Cervical dilation 3 cm) for 20 minutes. The patients were offered to choose among several virtual environments including orange sunset, green meadows, black beginning, red savannah, blue deep, blue moon, blue ocean, white winter, and red fall. Cards printed out from the images of the Nature Trek application representing these novel immersion options were provided to the patients to help them pick up their preferred environment in advance. The second implementation of VR headsets was after the epidural analgesia in the active phase of labor for another 20 minutes (Cervical dilation 6-7cm). After the second intervention, the "Virtual Reality Satisfaction Survey" was applied by the authors. Patients were asked to fill out a visual pain rating scale right before and after the VR use in early and active labor. The primary objective of this study was to assessed whether immersive virtual reality provided pain relief in the latent or active phase of labor. The authors also evaluated anxiety and depression in both groups on admission as potential confounders. Anxiety and depression levels, assessed with the Beck Anxiety Inventory and Beck Depression Inventory. Patient satisfaction with the use of VR was assessed by a "Virtual Reality Satisfaction Survey" 10 question survey prepared by our team: 0 being the lowest and 100 being the highest possible VR satisfaction score.The investigators also asked these women whether the participants would like to use VR in future labor. Patient satisfaction with overall labor and delivery experience was assessed using a Visual Analog Scale (VAS). All discharged women were called a week following discharge and asked to rate their overall childbirth experience on a scale from 0 to 10. Zero indicates the most negative experience possible and 10 indicates the highest satisfaction possible. The authors classified a score of 8 to 10 as high satisfaction. Pain scores both in early and active labor in each group were assessed using Wong-Baker Faces Pain Rating Scale.
- Conditions
- Labor Pain
- Being tested
- Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system
- Keywords
- Labor, Immersive Virtual Reality, Non-pharmacologic Treatment, Anxiety, Depression
- Medical subject headings
- Labor Pain, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculus Quest All-in-one VR Gaming Headset (128 GB) VR systemDevice
The laboring women who enrolled in the VR group were offered to choose among several virtual environments including orange sunset, green meadows, black beginning, red savannah, blue deep, blue moon, blue ocean, white winter, and red fall. Cards printed out from the screenshots of the Nature Trek application representing these novel immersion options were provided to the patients to help them pick up their preferred environment in advance.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Investigators used Oculus Quest All-in-one Virtual Reality Gaming Headset (128 GB) VR system. Before the intervention, the investigators introduced the equipment and instructed study participants on how to wear and activate the headsets. The laboring women who enrolled in the virtual reality group first wore the headsets in early labor (Cervical dilation 3 cm) for 20 minutes. The patients were offered to choose among several virtual environments including orange sunset, green meadows, black beginning, red savannah, blue deep, blue moon, blue ocean, white winter, and red fall. Cards printed out from the images of the Nature Trek application representing these novel immersion options were provided to the patients to help them pick up their preferred environment in advance. The second implementation of virtual reality headsets was after the epidural analgesia in the active phase of labor for another 20 minutes (Cervical dilation 6-7cm). Receives: Device: Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system |
| Control Group | No intervention | For participants randomized to the control group, virtual reality headsets were not used and the clinic's standard of care in laboring women was followed. Participants in this group filled out a visual pain rating scale both in the latent and active phases of labor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virtual Reality Satisfaction Survey
Patient satisfaction with the use of VR was assessed by a "Virtual Reality Satisfaction Survey" 10 question survey prepared by our team: 0 being the lowest and 100 being the highest possible VR satisfaction score.
Measured: During the intervention
Wong-Baker Faces Pain
Pain scores both in early and active labor in each group were assessed using Wong-Baker Faces Pain Rating Scale. The scale shows a series of 6 faces ranging from a happy face at 0, or "no hurt", to a crying face at 5, which represents "hurts like the worst pain
Measured: During the intervention
Visual Analog Scale (VAS)
Patient satisfaction with overall labor and delivery experience was assessed using a Visual Analog Scale (VAS). Zero indicates the most negative experience possible and 10 indicates the highest satisfaction possible.
Measured: A week after the labor
Secondary outcomes (2)
Beck Anxiety Inventory (BAI)
Anxiety levels of study participants were assessed with Beck Anxiety Inventory (BAI). [19] This inventory consists of 21 items, each scored from 0 to 3. This is a self-report questionnaire measuring somatic and cognitive parts of anxiety. The total score is calculated by finding the sum of 21 items. A score of 0 to 7 indicates minimal anxiety, 8 to 15 mild anxiety, 16 to 25 moderate anxiety, and 30 to 63 is associated with severe anxiety.
Measured: Pre-intervention, on admission
Beck Depression Inventory (BDI)
It consists of 21 items which is a multiple-choice test and give a score ranging from 0 to 63. Each answer is scored on a scale value of 0-3. Measures of 0-9 indicate that a person is not depressed, 10-18 indicates mild-moderate depression, 19-29 indicates moderate-severe depression and 30-63 indicates severe depression.
Measured: Pre-intervention, on admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start13 Nov 2020
- Primary completion10 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 42 laboring women allocated to intervention group and control group randomly
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Collaborators
- Acibadem Maslak Hospital
- Responsible party
- Principal investigator, Assoc. Prof. Dr. Selen Gür Özmen MD Phd, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032456
- Sponsor's protocol ID
- 2020-18/07
- Status last verified
- Aug 2021
- First submitted
- 20 Jul 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
ACOG Committee Opinion #295: pain relief during labor. Obstet Gynecol. 2004 Jul;104(1):213.
PubMed 15229040Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.
PubMed 29781504Nanji JA, Carvalho B. Pain management during labor and vaginal birth. Best Pract Res Clin Obstet Gynaecol. 2020 Aug;67:100-112. doi: 10.1016/j.bpobgyn.2020.03.002. Epub 2020 Mar 7.
PubMed 32265134Smith CA, Levett KM, Collins CT, Armour M, Dahlen HG, Suganuma M. Relaxation techniques for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009514. doi: 10.1002/14651858.CD009514.pub2.
PubMed 29589650Madden K, Middleton P, Cyna AM, Matthewson M, Jones L. Hypnosis for pain management during labour and childbirth. Cochrane Database Syst Rev. 2016 May 19;2016(5):CD009356. doi: 10.1002/14651858.CD009356.pub3.
PubMed 27192949Smith CA, Levett KM, Collins CT, Dahlen HG, Ee CC, Suganuma M. Massage, reflexology and other manual methods for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009290. doi: 10.1002/14651858.CD009290.pub3.
PubMed 29589380Dowswell T, Bedwell C, Lavender T, Neilson JP. Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007214. doi: 10.1002/14651858.CD007214.pub2.
PubMed 19370680Maani CV, Hoffman HG, Morrow M, Maiers A, Gaylord K, McGhee LL, DeSocio PA. Virtual reality pain control during burn wound debridement of combat-related burn injuries using robot-like arm mounted VR goggles. J Trauma. 2011 Jul;71(1 Suppl):S125-30. doi: 10.1097/TA.0b013e31822192e2.
PubMed 21795888Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.
PubMed 27349654Atzori B, Lauro Grotto R, Giugni A, Calabro M, Alhalabi W, Hoffman HG. Virtual Reality Analgesia for Pediatric Dental Patients. Front Psychol. 2018 Nov 23;9:2265. doi: 10.3389/fpsyg.2018.02265. eCollection 2018.
PubMed 30532720Walther-Larsen S, Petersen T, Friis SM, Aagaard G, Drivenes B, Opstrup P. Immersive Virtual Reality for Pediatric Procedural Pain: A Randomized Clinical Trial. Hosp Pediatr. 2019 Jul;9(7):501-507. doi: 10.1542/hpeds.2018-0249. Epub 2019 Jun 3.
PubMed 31160472Faruki A, Nguyen T, Proeschel S, Levy N, Yu J, Ip V, Mueller A, Banner-Goodspeed V, O'Gara B. Virtual reality as an adjunct to anesthesia in the operating room. Trials. 2019 Dec 27;20(1):782. doi: 10.1186/s13063-019-3922-2.
PubMed 31882015Wang YL, Gao HX, Wang JS, Wang JH, Bo L, Zhang TT, Dai YL, Gao LL, Liu Q, Zhang JJ, Cai JM, Yu JQ, Li YX. Immersive virtual reality as analgesia for women during hysterosalpingography: study protocol for a randomized controlled trial. Trials. 2020 Jan 20;21(1):102. doi: 10.1186/s13063-019-4023-y.
PubMed 31959220Hoffman HG, Richards TL, Coda B, Bills AR, Blough D, Richards AL, Sharar SR. Modulation of thermal pain-related brain activity with virtual reality: evidence from fMRI. Neuroreport. 2004 Jun 7;15(8):1245-8. doi: 10.1097/01.wnr.0000127826.73576.91.
PubMed 15167542Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PubMed 3204199
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality Improves Satisfaction In Laboring Women
- ClinicalTrials.gov ID
- NCT05032456
- Acronym / sponsor ID
- 2020-18/07
- Conditions
- Labor Pain
- Keywords
- Labor, Immersive Virtual Reality, Non-pharmacologic Treatment, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Collaborators
- Acibadem Maslak Hospital
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 2 Sep 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.
This is a randomized control study with 42 laboring women allocated to virtual reality intervention and control groups. The objective of this study, to evaluate the effectiveness of immersive virtual reality in laboring women on patient satisfaction and pain relief. The satisfaction of patients was measured with a "Virtual reality satisfaction survey" which was prepared by the investigators. Pain levels were assessed by a virtual pain rating scale in the early and the active phase of labor in both groups.
Detailed description
Labor is a long and painful process for women. For avoiding or alleviating pain, adjuvant treatments such as hydrotherapy, yoga, hypnosis, acupuncture, and relaxation techniques could be used. Recent literature indicates the successful use of immersive virtual reality for a variety of painful medical procedures. Immersive virtual reality is hypothesized to reduce pain through distraction, a non-pharmacologic attentional mechanism. The user's brain is preoccupied with the flood of information presented by the virtual environment restricting the mind from processing pain signals. The investigators hypothesized that laboring women find immersive virtual reality as a beneficial tool for their overall labor and delivery experience. The 42 laboring women were randomized into two arms: virtual reality group ( intervention group) and control group. The investigators used Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system. Before the intervention, the authors introduced the equipment and instructed study participants on how to wear and activate the headsets. Anxiety and depression scales were also applied on admission. The laboring women who enrolled in the VR group first wore the headsets in early labor (Cervical dilation 3 cm) for 20 minutes. The patients were offered to choose among several virtual environments including orange sunset, green meadows, black beginning, red savannah, blue deep, blue moon, blue ocean, white winter, and red fall. Cards printed out from the images of the Nature Trek application representing these novel immersion options were provided to the patients to help them pick up their preferred environment in advance. The second implementation of VR headsets was after the epidural analgesia in the active phase of labor for another 20 minutes (Cervical dilation 6-7cm). After the second intervention, the "Virtual Reality Satisfaction Survey" was applied by the authors. Patients were asked to fill out a visual pain rating scale right before and after the VR use in early and active labor. The primary objective of this study was to assessed whether immersive virtual reality provided pain relief in the latent or active phase of labor. The authors also evaluated anxiety and depression in both groups on admission as potential confounders. Anxiety and depression levels, assessed with the Beck Anxiety Inventory and Beck Depression Inventory. Patient satisfaction with the use of VR was assessed by a "Virtual Reality Satisfaction Survey" 10 question survey prepared by our team: 0 being the lowest and 100 being the highest possible VR satisfaction score.The investigators also asked these women whether the participants would like to use VR in future labor. Patient satisfaction with overall labor and delivery experience was assessed using a Visual Analog Scale (VAS). All discharged women were called a week following discharge and asked to rate their overall childbirth experience on a scale from 0 to 10. Zero indicates the most negative experience possible and 10 indicates the highest satisfaction possible. The authors classified a score of 8 to 10 as high satisfaction. Pain scores both in early and active labor in each group were assessed using Wong-Baker Faces Pain Rating Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 42 laboring women allocated to intervention group and control group randomly
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Oculus Quest All-in-one VR Gaming Headset (128 GB) VR systemInvestigators used Oculus Quest All-in-one Virtual Reality Gaming Headset (128 GB) VR system. Before the intervention, the investigators introduced the equipment and instructed study participants on how to wear and activate the headsets. The laboring women who enrolled in the virtual reality group first wore the headsets in early labor (Cervical dilation 3 cm) for 20 minutes. The patients were offered to choose among several virtual environments including orange sunset, green meadows, black beginning, red savannah, blue deep, blue moon, blue ocean, white winter, and red fall. Cards printed out from the images of the Nature Trek application representing these novel immersion options were provided to the patients to help them pick up their preferred environment in advance. The second implementation of virtual reality headsets was after the epidural analgesia in the active phase of labor for another 20 minutes (Cervical dilation 6-7cm). |
| Control Group | No intervention | –For participants randomized to the control group, virtual reality headsets were not used and the clinic's standard of care in laboring women was followed. Participants in this group filled out a visual pain rating scale both in the latent and active phases of labor. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-42 years of age
- 37-41 week gestation
- A singleton pregnancy
- With vertex presentation
- No history of chronic medical conditions
Key exclusion criteria (8 listed)
- Migraine
- Headache
- Dizziness
- Motion Sickness
- Epilepsy
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 |
|---|---|---|
| Oculus Quest All-in-one VR Gaming Headset (128 GB) VR systemThe laboring women who enrolled in the VR group were offered to choose among several virtual environments including orange sunset, green meadows, black beginning, red savannah, blue deep, blue moon, blue ocean, white winter, and red fall. Cards printed out from the screenshots of the Nature Trek application representing these novel immersion options were provided to the patients to help them pick up their preferred environment in advance. | Device | Virtual Reality Group |
Primary outcome
Virtual Reality Satisfaction Survey
Time frame: During the intervention
Patient satisfaction with the use of VR was assessed by a "Virtual Reality Satisfaction Survey" 10 question survey prepared by our team: 0 being the lowest and 100 being the highest possible VR satisfaction score.
Wong-Baker Faces Pain
Time frame: During the intervention
Pain scores both in early and active labor in each group were assessed using Wong-Baker Faces Pain Rating Scale. The scale shows a series of 6 faces ranging from a happy face at 0, or "no hurt", to a crying face at 5, which represents "hurts like the worst pain
Visual Analog Scale (VAS)
Time frame: A week after the labor
Patient satisfaction with overall labor and delivery experience was assessed using a Visual Analog Scale (VAS). Zero indicates the most negative experience possible and 10 indicates the highest satisfaction possible.
2 secondary outcomes
Beck Anxiety Inventory (BAI)
Time frame: Pre-intervention, on admission
Beck Depression Inventory (BDI)
Time frame: Pre-intervention, on admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Background: PubMed 15229040ACOG Committee Opinion #295: pain relief during labor. Obstet Gynecol. 2004 Jul;104(1):213.
- Background: PubMed 29781504Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.
- Background: PubMed 32265134Nanji JA, Carvalho B. Pain management during labor and vaginal birth. Best Pract Res Clin Obstet Gynaecol. 2020 Aug;67:100-112. doi: 10.1016/j.bpobgyn.2020.03.002. Epub 2020 Mar 7.
- Background: PubMed 29589650Smith CA, Levett KM, Collins CT, Armour M, Dahlen HG, Suganuma M. Relaxation techniques for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009514. doi: 10.1002/14651858.CD009514.pub2.
- Background: PubMed 27192949Madden K, Middleton P, Cyna AM, Matthewson M, Jones L. Hypnosis for pain management during labour and childbirth. Cochrane Database Syst Rev. 2016 May 19;2016(5):CD009356. doi: 10.1002/14651858.CD009356.pub3.
- Background: PubMed 29589380Smith CA, Levett KM, Collins CT, Dahlen HG, Ee CC, Suganuma M. Massage, reflexology and other manual methods for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009290. doi: 10.1002/14651858.CD009290.pub3.
- Background: PubMed 19370680Dowswell T, Bedwell C, Lavender T, Neilson JP. Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007214. doi: 10.1002/14651858.CD007214.pub2.
- Background: PubMed 21795888Maani CV, Hoffman HG, Morrow M, Maiers A, Gaylord K, McGhee LL, DeSocio PA. Virtual reality pain control during burn wound debridement of combat-related burn injuries using robot-like arm mounted VR goggles. J Trauma. 2011 Jul;71(1 Suppl):S125-30. doi: 10.1097/TA.0b013e31822192e2.
- Background: PubMed 27349654Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.
- Background: PubMed 30532720Atzori B, Lauro Grotto R, Giugni A, Calabro M, Alhalabi W, Hoffman HG. Virtual Reality Analgesia for Pediatric Dental Patients. Front Psychol. 2018 Nov 23;9:2265. doi: 10.3389/fpsyg.2018.02265. eCollection 2018.
- Background: PubMed 31160472Walther-Larsen S, Petersen T, Friis SM, Aagaard G, Drivenes B, Opstrup P. Immersive Virtual Reality for Pediatric Procedural Pain: A Randomized Clinical Trial. Hosp Pediatr. 2019 Jul;9(7):501-507. doi: 10.1542/hpeds.2018-0249. Epub 2019 Jun 3.
- Background: PubMed 31882015Faruki A, Nguyen T, Proeschel S, Levy N, Yu J, Ip V, Mueller A, Banner-Goodspeed V, O'Gara B. Virtual reality as an adjunct to anesthesia in the operating room. Trials. 2019 Dec 27;20(1):782. doi: 10.1186/s13063-019-3922-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system in people with Labor Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 2 Sep 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virtual Reality Satisfaction Survey (time frame: During the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05032456, which also lists 34 linked publications.
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 2 Sep 2021.