Virtual Reality, Labor Pain, Anxiety, Birth Perception

NCT ID: NCT05495009

Last Updated: 2022-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-21

Study Completion Date

2021-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The research was carried out in a randomized controlled trial to determine the effect of using virtual reality glasses on labor pain, anxiety, and labor perception of pregnant women. 60 pregnant women participated in the study at the Maternity and Children's Hospital located in the city center of Bolu. The data were collected via Introductory information form, Visual Comparison Scale-Pain, Visual Comparison Scale-Anxiety, labor follow-up form, Mother's Perception of Birth Scale, and virtual reality satisfaction evaluation form. Number, percentage, mean, standard deviation, Pearson chi-square, t-test for both groups were used to evaluate the data via the SPSS program. Statistical significance was accepted as p\<0.05. Pregnant women in the experimental and control groups were found to be homogeneous in terms of sociodemographic and obstetric characteristics (p\>0.05). At the beginning of labor, both pregnant groups showed similar score of the mean pain and anxiety(p\>0.05). After applying 20 minutes in the active phase and 10 minutes in the transitional phase, the mean pain and anxiety scores of the experimental group were found to be lower, and this difference was found to be statistically significant(p\<0.001). In the postpartum period, it was determined that the birth Perception Scale mean scores of the groups were similar. 90% of the pregnant women reported that they were satisfied with the virtual reality application and 93% of them reported that they would recommend this application. As a result, the use of virtual reality during birth reduces pain and anxiety at birth but does not affect the perception of birth.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Childbirth is one of the important experiences in a woman's life and this experience is affected by subjective, psychological and physiological processes. While birth is a positive life experience for some women , it is a traumatic and negative experience for others .

One of the factors that most affect women who experience many emotions together during the birth process is labor pain. The perception and severity of labor pain, which is part of the normal process, varies from person to person. In the literature, it has been shown that 50-52% of women experience severe labor pain. Severe labor pain may be associated with decreased uteroplacental perfusion, prolongation of labor and labor with intervention, postpartum depression and anxiety by causing an increase in maternal catecholamine levels. This leads to a prolonged hospital stay, difficulty in performing basic activities, and consequently a negative birth experience It also leads women who want to avoid pain to prefer cesarean delivery instead of vaginal delivery.

The birth process is also an important source of anxiety in women. Studies have shown that women experience moderate anxiety about childbirth. It is known that anxiety experienced at birth affects the health of the mother, fetus and newborn negatively and increases the severity of labor pain. Pain that comes at frequent and intense intervals increases the anxiety level of the woman, leading to increased tension in the pelvic muscles, fatigue, and inadequate coping with pain . There is a two-way relationship between anxiety and pain in childbirth, and this vicious cycle between anxiety and pain negatively affects the course of labor, reduces the self-confidence of the pregnant woman and causes her to feel helpless and unsuccessful.

Pain and anxiety are important factors affecting birth perception and birth outcomes. Effective management of pain and anxiety at birth for a positive birth experience is among the main goals of obstetric care. The most effective strategies for a positive birth experience; It has been reported that creating a positive birth environment, supporting women during childbirth, intrapartum care with minimal intervention, preparation for childbirth, relaxation and pain relief applications .

Pharmacological and non-pharmacological methods are used to effectively cope with pain at birth. Pharmacological methods require attention in their use because of their side effects, application limitations, and uncertainties of their effects on the mother and fetus .

The use of non-pharmacological methods, which are easy to apply, safe, and have various advantages in ensuring active participation and cooperation of women in the birth process, without using any medication, is becoming more common in pain management. Studies have emphasized that non-pharmacological methods reduce pain and anxiety levels during the birth process, increase maternal satisfaction at birth, and strengthen mother-infant communication.

Distraction, focusing and relaxation by daydreaming are among the commonly used non-pharmacological methods in reducing pain. However, since dreaming and daydreaming can be difficult during the birth process, it is recommended to use applications that will facilitate this . For this purpose, virtual reality glasses have been used in recent years. With these glasses, a visual experience environment is created through three-dimensional videos by creating a real-like virtual world for individuals.

It has been shown that the clinical use of virtual reality glasses, which can be used in many areas, is useful and reliable. These glasses are used in children during painful invasive procedures, acute and chronic pain management, burn treatments, preoperative anxiety, psychiatric diagnosis and treatment interventions, physical therapy and rehabilitation applications are used.

Although virtual reality has been shown to be an effective method in the management of pain and anxiety, studies showing its effect on pain at birth and anxiety are limited. Based on these data, in this study, it was aimed to determine the effect of the video watched by using virtual reality glasses during labor on labor pain, anxiety and labor perception of pregnant women.

Research Hypotheses H0 : Watching video with virtual reality glasses has no effect on labor pain, anxiety and birth perception.

H1: Watching video with virtual reality glasses has an effect on labor pain. H2: Watching video with virtual reality glasses has an effect on anxiety at birth.

H3: Watching a video with virtual reality glasses has an effect on birth perception.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labor Pain Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled experimental research
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of care

Introductory information form (IIF), labor follow-up form (FFL) and VAS-P, VAS-A were filled in the latent phase (1-3 cm). At the beginning of the active (4 cm) and transitional phases (8 cm), FFL, VAS-P and VAS-A were filled and no intervention was applied. 20 min in active phase. then, FFL, VAS-P and VAS-A were filled after 10 min in the transition phase. The Perception of Birth Scale is filled after birth.

Group Type NO_INTERVENTION

No interventions assigned to this group

Standard of care+ virtual reality glasses

Introductory information form (IIF), labor follow-up form (FFL) and VAS-P, VAS-A were filled in the latent phase (1-3 cm). At the beginning of the active (4 cm) and transitional phases (8 cm), after filling FFL, VAS-P and VAS-A, video was watched with virtual reality glasses. 20 minutes in active phase after watching the video. then, FFL, VAS-P and VAS-A were filled after 10 min in the transition phase. After the birth, the Perception of Birth Scale and Virtual Reality Satisfaction Form were filled.

Group Type EXPERIMENTAL

Standard of care+virtual reality glasses

Intervention Type OTHER

At the beginning of the active and transitional phases of labor, videos were watched with virtual reality glasses.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard of care+virtual reality glasses

At the beginning of the active and transitional phases of labor, videos were watched with virtual reality glasses.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Able to communicate verbally
* Between the ages of 18-35
* No pregnancy-related risk diagnosis,
* Primiparous,
* Vaginal delivery planned,
* Gestational week is between 37-42,
* Single, live fetus and head presentation,
* In the latent phase (1-3 cm) on admission to the delivery room,
* Not having any dystocia that may affect the duration of labor (placental dystocia, pelvic dystocia, etc.).
* No induction,
* No epidural anaesthesia.
* Pregnant women without vision and hearing problems were included in the study.

Exclusion Criteria

* Refusing to participate in the research,
* Diagnosed with risky pregnancy,
* Watching the video in active phase for less than 20 minutes
* Watching the video in transition phase for less than 10 minutes
* Cesarean section
* Pregnant women who used any pharmacological analgesia were not included in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mervenur BÖYÜK

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mervenur BÖYÜK

Role: PRINCIPAL_INVESTIGATOR

Baibu

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

İzzet Baysal State Hospital, Obstetrics and Pediatrics Unit, delivery room service

Bolu, Center, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Boyuk M, Citak Bilgin N. Childbirth Journey Through Virtual Reality: Pain, Anxiety and Birth Perception: A Randomized Controlled Trial. Res Nurs Health. 2025 Apr;48(2):179-189. doi: 10.1002/nur.22438. Epub 2025 Jan 3.

Reference Type DERIVED
PMID: 39749486 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

İBDH-KDÜ-MB-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Virtual Reality for Pain and Anxiety Relief in Labor
NCT07194967 ENROLLING_BY_INVITATION NA
The Effect of Virtual Reality Glasses on Labor Pain
NCT01687933 COMPLETED PHASE2/PHASE3
Developing an Immersive Virtual Reality Platform
NCT07161141 NOT_YET_RECRUITING NA
Virtual Reality for Anxiety Relief in Infertile Women
NCT07020975 ENROLLING_BY_INVITATION NA