The Effect of Virtual Reality Glass During Labor Process on Labor Pain, Birth Perception and Anxiety

NCT ID: NCT04664114

Last Updated: 2020-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2020-10-16

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).

Conditions

Birth, First

Keywords

birth; Virtual reality; anxiety; pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: BEHAVIORAL

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.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Ultrasonography (USG)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Mine Yilmaz Koçak

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mine Yilmaz Koçak

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 33960065 (View on PubMed)

Other Identifiers

2020/259

Identifier Type: -

Identifier Source: org_study_id