Birth, FirstVRNCT04664114
The Effect of Virtual Reality Glass During Labor Process on Labor Pain, Birth Perception and Anxiety
A study testing Virtual Reality in people with Birth, First, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study was conducted to determine the effect of showing images of the fetus to the pregnant women with the virtual reality glass during labor process on labor pain, birth perception and anxiety level. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth, First
- What is being tested?
- Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 16 Oct 2020
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- at 28 weeks of gestation (because the images of the fetus can be taken more clearly)
- Primipara,
- Having a head presentation,
- Without any risk conditions related to the pregnant and fetus (preeclampsia, gestational diabetes, presentation anomalies, placenta related anomalies, fetal distress and anomaly),
- Over the age of 18,
- Can understand and speak Turkish,
- Pregnant women who agreed to participate in the study after giving information about the study
Who cannot join
- Elective cesarean section
- Conceived with assisted reproductive techniques
- Pregnant women with vision and hearing problems were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Viewing Images of Fetus to Pregnant Women With Virtual Reality Glasses on Birth Pain, Perception and Anxiety During Labor
Aim: This study was conducted to determine the effect of showing images of the fetus to the pregnant women with the virtual reality glass during labor process on labor pain, birth perception and anxiety level.
Background: Virtual reality (VR) is an effective and inexpensive method that allows the creation of simulated scenarios in which it interacts with the virtual environment with multisensory stimuli.
Read more
Methods: This is a randomized controlled experimental study. The study included 100 pregnant women of whom 50 in the intervention group and 50 in the control group. Ultrasound images of the fetus were recorded on the 28th week of pregnancy of the women in the intervention group. These images were shown to the women with the virtual reality glass during labor process. Routine procedures were carried out for the women in the control group. The Visual Analog Scale (VAS) was applied to both groups when cervical dilatation was 4 cm and 9 cm. The Women's Perception for the Scale of Supportive Care Given During Labor (POBS) and the Perinatal Anxiety Screening Scale (PASS) were applied almost two hours after labor.
Keywords: Virtual reality, labor, pain, anxiety.
Read the detailed description
Performed on the pregnant women in the intervention group (Virtual Reality Glass Group-VRGG) Pregnant women who met the inclusion criteria and were in the 28th weeks of pregnancy were assigned in the intervention or control group according to the randomization chart when they came to the Obstetrics and Gynecology Polyclinic for pregnancy follow-up. Pregnant women in the intervention group were informed about the study, and their verbal and written consent was obtained. The third author and the Gynecology and Obstetrics Specialist evaluated the presentation of the baby, amniotic fluid, placenta, umbilical artery doppler, fetal biometry (BPD, HC, AC, FL) and fetal respiration with the Voluson 730 PRO ultrasound device. In the remaining time, if the position of the baby is suitable, it was ensured that video images were recorded on the phone of the pregnant woman by looking at the baby's face with the help of a 3D / 4D probe. Although it might be performed in earlier and later weeks, such visual evaluations are made in the 27th-28th weeks since the visualization is better. The ultrasound session both for the evaluation of the fetus and for visual purposes took 15-20 minutes in total. These pregnant women were asked to bring their phone that the video was recorded with them to the labor. When the pregnant women got into labor, they were hospitalized by the third researcher. The follow-ups and labor were also performed by the third author. These two-dimensional images were converted into three-dimensional images through an application installed in the mother's phone and were shown to her with a VR Box 3 D virtual reality glass one after another. In cases where the program was not compatible with the mother's phone, it was watched on the researcher's phone. The total duration of image viewing was recorded.
Practices performed on the pregnant women in the control group (Control Group-CG) Pregnant women who met the inclusion criteria and were in the 28th weeks of pregnancy were assigned to the control group according to the randomization chart. When the pregnant women got into labor, they were hospitalized by the third researcher. No practices other than the routine were applied on pregnant women in the control group. These routine practices are monitoring pregnant women's cervical dilation, contraction and fetal heart rate, providing freedom of action, restricting oral intake for labor duration. No oxytocin induction or any analgesic were applied on the pregnant women in both groups. The rooms where the pregnant women stayed were kept dim and calm. The pregnant women in the control group were monitored and delivered by the third author during the labor process. For not hampering the monitoring of pregnant women, only one pregnant woman was included in the study at the same time. The Visual Analog Scale (VAS) was applied to both groups when cervical dilatation was 4 cm and 9 cm. The Women's Perception for the Scale of Supportive Care Given During Labor (POBS) and the Perinatal Anxiety Screening Scale (PASS) were applied almost two hours after labor (so that the mother had time to breastfeed the baby and the mother's vital signs were stabilized).
- Conditions
- Birth, First
- Being tested
- Virtual Reality
- Keywords
- birth, Virtual reality, anxiety, pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
Also called Ultrasonography (USG)
Ultrasound images of the fetus in the 28th week of pregnancy of the women in the intervention group were recorded. These images were shown to the woman through virtual reality glasses during the labor. Routine practices in the hospital were made to the women in the control group. VAS (Visual Analog Scale) was applied to women in both groups when cervical dilatation was 4 and 9 cm. Approximately two hours after giving birth (to allow mothers to breastfeed their babies and to stabilize the mother's vital signs), the Women's Perception of Supportive Care at Birth Scale (POBS) and Perinatal Anxiety Screening Scale (PASS) were administered.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Both the evaluation of the fetus and the ultrasound for visual purposes took 15-20 minutes in total. These pregnant women were asked to bring their mobile phones with them during delivery. When the birth of the pregnant woman started, she was hospitalized by the third researcher. The follow-up and deliveries during the labor were carried out by the 3rd and 4th researchers. With an application installed on the pregnant woman's phone, these two-dimensional images were transformed into three-dimensional images and the pregnant women were watched consecutively with the VR Box 3D virtual reality glasses. In cases where the program was not compatible with the phone of the pregnant woman, the researcher was watched by the midwife. The total image viewing time was recorded. Receives: Behavioral: Virtual Reality |
| Control Group | No intervention | Only one pregnant woman was included in the study at the same time in order to avoid any interruption in the follow-up of the pregnant women. VAS was applied to women in both groups when cervical dilatation was 4 and 9 cm. Approximately two hours after giving birth (to allow mothers to breastfeed their babies and to stabilize the mother's vital signs), the Women's Perception of Supportive Care at Birth Scale and the Perinatal Anxiety Screening Scale were applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Birth pain. VAS is a horizontal or vertical line of 10 cm/100 mm that starts with "No pain" and ends with "Unbearable pain." No pain is written on one end and very severe or unbearable pain is written on the other end on the scale during the measurement and the patient marks their current state on this line. The length of the distance from no pain to the point marked by the patient indicates the patient's pain.
Measured: The progression time of vaginal dilatation at birth may vary from person to person. For this reason, measurement will be made when the vaginal dilatation is 4 cm from the beginning of the birth process.
Visual Analog Scale (VAS)
Birth pain. VAS is a horizontal or vertical line of 10 cm/100 mm that starts with "No pain" and ends with "Unbearable pain." No pain is written on one end and very severe or unbearable pain is written on the other end on the scale during the measurement and the patient marks their current state on this line. The length of the distance from no pain to the point marked by the patient indicates the patient's pain.
Measured: The progression time of vaginal dilatation at birth may vary from person to person. For this reason, measurement will be made when the vaginal dilatation is 9 cm from the beginning of the birth process.
Perinatal Anxiety Screening Scale (PASS)
women's anxiety level.The Perinatal Anxiety Scale (PASS) has 31 items. It is a valid and reliable scale that can be used to screen anxiety disorders among perinatal women. The answers to the questions in the scale are "never," "sometimes," "often" and "almost always" and the scores are 0, 1, 2, 3 and its cutoff score is 16.
Measured: Birth time can vary from person to person. For this reason, measurement will be made when it is 2 hours after the end of labor.
Perception for the Scale of Supportive Care Given During Labor (POBS)
women's birth perception level. The Perception for the Scale of Supportive Care Given During Labor (POBS) scale has 33 items. It was determined to be valid and reliable to measure the women's perception for the supportive care given during labor. It is recommended to use within the first 24 hours after labor. The scale has three subdimensions. The first dimension includes behaviors that make women feel comfortable, the second dimension includes informative behaviors and the third dimension includes behaviors that disturb women. The lowest possible score obtained from the scale is 33 while the highest score is 132. It has no cut-off point. Higher scores indicate well-perceived supportive care.
Measured: Birth time can vary from person to person. For this reason, measurement will be made when it is 2 hours after the end of labor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Feb 2020
- Primary completion15 Oct 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth, FirstStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled experimental study. The study intervention group was carried out with a total of 100 pregnant women, 50 of whom were controls.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine Yilmaz Koçak, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664114
- Sponsor's protocol ID
- 2020/259
- Acronym
- VR
- Status last verified
- Dec 2020
- First submitted
- 10 Nov 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akin B, Yilmaz Kocak M, Kucukaydin Z, Guzel K. The Effect of Showing Images of the Foetus with the Virtual Reality Glass During Labour Process on Labour Pain, Birth Perception and Anxiety. J Clin Nurs. 2021 Aug;30(15-16):2301-2308. doi: 10.1111/jocn.15768. Epub 2021 May 6.
PubMed 33960065
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Viewing Images of Fetus to Pregnant Women With Virtual Reality Glasses on Birth Pain, Perception and Anxiety During Labor
- ClinicalTrials.gov ID
- NCT04664114
- Acronym / sponsor ID
- VR / 2020/259
- Conditions
- Birth, First
- Keywords
- birth, Virtual reality, anxiety, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 11 Dec 2020 (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.
Aim: This study was conducted to determine the effect of showing images of the fetus to the pregnant women with the virtual reality glass during labor process on labor pain, birth perception and anxiety level.
Background: Virtual reality (VR) is an effective and inexpensive method that allows the creation of simulated scenarios in which it interacts with the virtual environment with multisensory stimuli.
Methods: This is a randomized controlled experimental study. The study included 100 pregnant women of whom 50 in the intervention group and 50 in the control group. Ultrasound images of the fetus were recorded on the 28th week of pregnancy of the women in the intervention group. These images were shown to the women with the virtual reality glass during labor process. Routine procedures were carried out for the women in the control group. The Visual Analog Scale (VAS) was applied to both groups when cervical dilatation was 4 cm and 9 cm. The Women's Perception for the Scale of Supportive Care Given During Labor (POBS) and the Perinatal Anxiety Screening Scale (PASS) were applied almost two hours after labor.
Keywords: Virtual reality, labor, pain, anxiety.
Detailed description
Performed on the pregnant women in the intervention group (Virtual Reality Glass Group-VRGG) Pregnant women who met the inclusion criteria and were in the 28th weeks of pregnancy were assigned in the intervention or control group according to the randomization chart when they came to the Obstetrics and Gynecology Polyclinic for pregnancy follow-up. Pregnant women in the intervention group were informed about the study, and their verbal and written consent was obtained. The third author and the Gynecology and Obstetrics Specialist evaluated the presentation of the baby, amniotic fluid, placenta, umbilical artery doppler, fetal biometry (BPD, HC, AC, FL) and fetal respiration with the Voluson 730 PRO ultrasound device. In the remaining time, if the position of the baby is suitable, it was ensured that video images were recorded on the phone of the pregnant woman by looking at the baby's face with the help of a 3D / 4D probe. Although it might be performed in earlier and later weeks, such visual evaluations are made in the 27th-28th weeks since the visualization is better. The ultrasound session both for the evaluation of the fetus and for visual purposes took 15-20 minutes in total. These pregnant women were asked to bring their phone that the video was recorded with them to the labor. When the pregnant women got into labor, they were hospitalized by the third researcher. The follow-ups and labor were also performed by the third author. These two-dimensional images were converted into three-dimensional images through an application installed in the mother's phone and were shown to her with a VR Box 3 D virtual reality glass one after another. In cases where the program was not compatible with the mother's phone, it was watched on the researcher's phone. The total duration of image viewing was recorded.
Practices performed on the pregnant women in the control group (Control Group-CG) Pregnant women who met the inclusion criteria and were in the 28th weeks of pregnancy were assigned to the control group according to the randomization chart. When the pregnant women got into labor, they were hospitalized by the third researcher. No practices other than the routine were applied on pregnant women in the control group. These routine practices are monitoring pregnant women's cervical dilation, contraction and fetal heart rate, providing freedom of action, restricting oral intake for labor duration. No oxytocin induction or any analgesic were applied on the pregnant women in both groups. The rooms where the pregnant women stayed were kept dim and calm. The pregnant women in the control group were monitored and delivered by the third author during the labor process. For not hampering the monitoring of pregnant women, only one pregnant woman was included in the study at the same time. The Visual Analog Scale (VAS) was applied to both groups when cervical dilatation was 4 cm and 9 cm. The Women's Perception for the Scale of Supportive Care Given During Labor (POBS) and the Perinatal Anxiety Screening Scale (PASS) were applied almost two hours after labor (so that the mother had time to breastfeed the baby and the mother's vital signs were stabilized).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled experimental study. The study intervention group was carried out with a total of 100 pregnant women, 50 of whom were controls.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Virtual RealityBoth the evaluation of the fetus and the ultrasound for visual purposes took 15-20 minutes in total. These pregnant women were asked to bring their mobile phones with them during delivery. When the birth of the pregnant woman started, she was hospitalized by the third researcher. The follow-up and deliveries during the labor were carried out by the 3rd and 4th researchers. With an application installed on the pregnant woman's phone, these two-dimensional images were transformed into three-dimensional images and the pregnant women were watched consecutively with the VR Box 3D virtual reality glasses. In cases where the program was not compatible with the phone of the pregnant woman, the researcher was watched by the midwife. The total image viewing time was recorded. |
| Control Group | No intervention | –Only one pregnant woman was included in the study at the same time in order to avoid any interruption in the follow-up of the pregnant women. VAS was applied to women in both groups when cervical dilatation was 4 and 9 cm. Approximately two hours after giving birth (to allow mothers to breastfeed their babies and to stabilize the mother's vital signs), the Women's Perception of Supportive Care at Birth Scale and the Perinatal Anxiety Screening Scale were applied. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- at 28 weeks of gestation (because the images of the fetus can be taken more clearly)
- Primipara,
- Having a head presentation,
- Without any risk conditions related to the pregnant and fetus (preeclampsia, gestational diabetes, presentation anomalies, placenta related anomalies, fetal distress and anomaly),
- Over the age of 18,
Key exclusion criteria (3 listed)
- Elective cesarean section
- Conceived with assisted reproductive techniques
- Pregnant women with vision and hearing problems were excluded from the study.
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 RealityAlso: Ultrasonography (USG)Ultrasound images of the fetus in the 28th week of pregnancy of the women in the intervention group were recorded. These images were shown to the woman through virtual reality glasses during the labor. Routine practices in the hospital were made to the women in the control group. VAS (Visual Analog Scale) was applied to women in both groups when cervical dilatation was 4 and 9 cm. Approximately two hours after giving birth (to allow mothers to breastfeed their babies and to stabilize the mother's vital signs), the Women's Perception of Supportive Care at Birth Scale (POBS) and Perinatal Anxiety Screening Scale (PASS) were administered. | Behavioural | Experimental group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: The progression time of vaginal dilatation at birth may vary from person to person. For this reason, measurement will be made when the vaginal dilatation is 4 cm from the beginning of the birth process.
Birth pain. VAS is a horizontal or vertical line of 10 cm/100 mm that starts with "No pain" and ends with "Unbearable pain." No pain is written on one end and very severe or unbearable pain is written on the other end on the scale during the measurement and the patient marks their current state on this line. The length of the distance from no pain to the point marked by the patient indicates the patient's pain.
Visual Analog Scale (VAS)
Time frame: The progression time of vaginal dilatation at birth may vary from person to person. For this reason, measurement will be made when the vaginal dilatation is 9 cm from the beginning of the birth process.
Birth pain. VAS is a horizontal or vertical line of 10 cm/100 mm that starts with "No pain" and ends with "Unbearable pain." No pain is written on one end and very severe or unbearable pain is written on the other end on the scale during the measurement and the patient marks their current state on this line. The length of the distance from no pain to the point marked by the patient indicates the patient's pain.
Perinatal Anxiety Screening Scale (PASS)
Time frame: Birth time can vary from person to person. For this reason, measurement will be made when it is 2 hours after the end of labor.
women's anxiety level.The Perinatal Anxiety Scale (PASS) has 31 items. It is a valid and reliable scale that can be used to screen anxiety disorders among perinatal women. The answers to the questions in the scale are "never," "sometimes," "often" and "almost always" and the scores are 0, 1, 2, 3 and its cutoff score is 16.
Perception for the Scale of Supportive Care Given During Labor (POBS)
Time frame: Birth time can vary from person to person. For this reason, measurement will be made when it is 2 hours after the end of labor.
women's birth perception level. The Perception for the Scale of Supportive Care Given During Labor (POBS) scale has 33 items. It was determined to be valid and reliable to measure the women's perception for the supportive care given during labor. It is recommended to use within the first 24 hours after labor. The scale has three subdimensions. The first dimension includes behaviors that make women feel comfortable, the second dimension includes informative behaviors and the third dimension includes behaviors that disturb women. The lowest possible score obtained from the scale is 33 while the highest score is 132. It has no cut-off point. Higher scores indicate well-perceived supportive care.
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 11 Dec 2020.
- Derived from this study: PubMed 33960065Akin B, Yilmaz Kocak M, Kucukaydin Z, Guzel K. The Effect of Showing Images of the Foetus with the Virtual Reality Glass During Labour Process on Labour Pain, Birth Perception and Anxiety. J Clin Nurs. 2021 Aug;30(15-16):2301-2308. doi: 10.1111/jocn.15768. Epub 2021 May 6.
- Individual participant dataSharing planned: No
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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 Virtual Reality in people with Birth, First, run by Selcuk 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 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 11 Dec 2020. 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?
Visual Analog Scale (VAS) (time frame: The progression time of vaginal dilatation at birth may vary from person to person. For this reason, measurement will be made when the vaginal dilatation is 4 cm from the beginning of the birth process.). The study lists 4 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 NCT04664114, which also lists 1 linked publication.
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 11 Dec 2020.