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

NCT04664114 | Completed

• 1 other identifier: 2020/259
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Birth, First

Keywords

birth; Virtual reality; anxiety; pain

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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.

Study Arms (2)

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.

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.

Interventions

Virtual Reality 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.

Also known as: Ultrasonography (USG)

Experimental group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregmant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Mine Yilmaz Koçak

Konya, 42250, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33960065 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: December 11, 2020
• Study Start: February 1, 2020
• Primary Completion: October 15, 2020
• Study Completion: October 16, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)