Clinical trial NCT04664114: The Effect of Virtual Reality Glass During Labor Process on Labor Pain, Birth Perception and Anxiety
Official title: The Effect of Viewing Images of Fetus to Pregnant Women With Virtual Reality Glasses on Birth Pain, Perception and Anxiety During Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth, First
Keywords: birth
Virtual reality
anxiety
pain
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Elective cesarean section
* Conceived with assisted reproductive techniques
* Pregnant women with vision and hearing problems were excluded from the study.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 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.
measure: Visual Analog Scale (VAS)
timeFrame: 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.
measure: Perinatal Anxiety Screening Scale (PASS)
timeFrame: 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.
measure: Perception for the Scale of Supportive Care Given During Labor (POBS)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Mine Yilmaz Koçak
Study officials:
References:
citation: 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.