An Evaluation of Virtual Reality in Labor Pain During Vaginal ChildbirthNCT06677463
An Evaluation of Virtual Reality in Labor Pain During Vaginal Childbirth
A study testing Virtual Reality in people with An Evaluation of Virtual Reality in Labor Pain During Vaginal Childbirth, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate the effect of applying virtual reality among laboring women during first stage of labor Read more about this study
- Who is it for?
- Ages 20 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- An Evaluation of Virtual Reality in Labor Pain During Vaginal Childbirth
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2024to 30 Oct 2024
- 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 20 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20-25 years old .
- body mass index (BMI) 25- 32 kg/m2 .
- Primiparous .
- Highly educated.
Who cannot join
- Laboring women with high risk pregnancy.
- Laboring women are taking pharmacological methods to relieve pain during first stage of labor.
- Low educated women
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to evaluate the effect of applying virtual reality among laboring women during first stage of labor
Read the detailed description
This study will be conducted to evaluate the effect of applying virtual reality among laboring women during first stage of labor
- Being tested
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Studying the effect of virtual reality glasses on women during pregnancy, for the first time, it is also used to facilitate the birth process
| Study group | Role | What they receive |
|---|---|---|
| An experimental study on the effect of virtual reality glasses on women during childbirth | Experimental | An experimental study on the effect of virtual reality glasses on women during childbirth Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum cortisol levels
Serum cortisol levels during the normal labor
Measured: Immediately after the intervention
Time of labor
Measure the time of labor after delivery
Measured: Immediately after the intervention
Type of labor normal , cesarean section or episiotomy
Type of delivery
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start20 Oct 2024
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for An Evaluation of Virtual Reality in Labor Pain During Vaginal ChildbirthStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will be conducted to evaluate the effect of applying virtual reality among laboring women during first stage of labor
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amgad Hamed Abo motaa, Kafrelsheikh University
- Investigators
- Fayiz Elshamy Elshamy Fayiz Elshamy, Professor of physical therapy, Principal investigator, Fayiz Elshamy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677463
- Sponsor's protocol ID
- KFS IRB200-91
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: These pregnant women were asked to bring their phone that the video was recorded with them to the labour. When the pregnant women got into labour, they would hospitalized . The follow-ups and labour will also performed . These two-dimensional images will converted into three-dimensional images through an application installed in the mother's phone and will showe to her with a VR Box 3D virtual reality glass one after another. In cases where the program was not compatible with the mother's phone, it will watched on the researcher's phone. The total duration of image viewing was recorded. Procedure of application of virtual reality from cervical dilatation 3 cm to full dilatation
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Virtual Reality in Labor Pain During Vaginal Childbirth
- ClinicalTrials.gov ID
- NCT06677463
- Acronym / sponsor ID
- KFS IRB200-91
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 6 Nov 2024 (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 study will be conducted to evaluate the effect of applying virtual reality among laboring women during first stage of labor
Detailed description
This study will be conducted to evaluate the effect of applying virtual reality among laboring women during first stage of labor
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will be conducted to evaluate the effect of applying virtual reality among laboring women during first stage of labor
| Arm | Type | Receives |
|---|---|---|
| An experimental study on the effect of virtual reality glasses on women during childbirth | Experimental | Device: Virtual RealityAn experimental study on the effect of virtual reality glasses on women during childbirth |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 20-25 years old .
- body mass index (BMI) 25- 32 kg/m2 .
- Primiparous .
- Highly educated.
Key exclusion criteria (3 listed)
- Laboring women with high risk pregnancy.
- Laboring women are taking pharmacological methods to relieve pain during first stage of labor.
- Low educated women
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 |
|---|---|---|
| Virtual RealityStudying the effect of virtual reality glasses on women during pregnancy, for the first time, it is also used to facilitate the birth process | Device | An experimental study on the effect of virtual reality glasses on women during childbirth |
Primary outcome
Serum cortisol levels
Time frame: Immediately after the intervention
Serum cortisol levels during the normal labor
Time of labor
Time frame: Immediately after the intervention
Measure the time of labor after delivery
Type of labor normal , cesarean section or episiotomy
Time frame: Immediately after the intervention
Type of delivery
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 6 Nov 2024.
- Individual participant dataSharing planned: No. These pregnant women were asked to bring their phone that the video was recorded with them to the labour. When the pregnant women got into labour, they would hospitalized . The follow-ups and labour will also performed . These two-dimensional images will converted into three-dimensional images through an application installed in the mother's phone and will showe to her with a VR Box 3D virtual reality glass one after another. In cases where the program was not compatible with the mother's phone, it will watched on the researcher's phone. The total duration of image viewing was recorded. Procedure of application of virtual reality from cervical dilatation 3 cm to full dilatation
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.
Fayiz Elshamy Elshamy Fayiz Elshamy, Professor of physical therapy principal investigator
Fayiz Elshamy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with An Evaluation of Virtual Reality in Labor Pain During Vaginal Childbirth, run by Kafrelsheikh University at 1 site in Egypt.
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 4 inclusion and 3 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 6 Nov 2024. 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 Egypt. 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?
Serum cortisol levels (time frame: Immediately after 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?
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 6 Nov 2024.