Virtual Reality, Labor Pain, Anxiety, Birth Perception

NCT05495009 | Completed

• 1 other identifier: İBDH-KDÜ-MB-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain; Anxiety

Keywords

labor; pain; anxiety; birth perception; virtual reality

Outcome Measures

Primary Outcomes (9)

• pre-intervention pain at the start of the active phase was assessed by Visual Analogue Scale-Pain (VAS-P)

  The scale is a 10 cm ruler that represents painlessness at one end (0=no pain) and the most severe pain (10=severe pain) at the other end. The patient is asked to put a line or mark on the point representing the intensity of pain. The part from the "no pain" point to the point marked by the participant is measured in mm and the value found indicates the patient's pain level.

  It was applied before the intervention was performed when the cervical opening was 4 cm.

• post-intervention pain at the start of the active phase was assessed Visual Analogue Scale-Pain (VAS-P)

  The scale is a 10 cm ruler that represents painlessness at one end (0=no pain) and the most severe pain (10=severe pain) at the other end. The patient is asked to put a line or mark on the point representing the intensity of pain. The part from the "no pain" point to the point marked by the participant is measured in mm and the value found indicates the patient's pain level.

  It was applied after the intervention was performed when the cervical opening was 4 cm.

• pre-intervention anxiety at the start of the active phase was assessed by Visual Analogue Scale-Anxiety (VAS-A)

  The scale is a 10 cm ruler representing the absence of anxiety (0 = no anxiety) at one end and the most severe anxiety (10 = severe anxiety) at the other end. The patient is asked to put a line or mark on the area showing the level of anxiety. The part from the no anxiety point to the point marked by the patient is measured in mm and the value found indicates the patient's anxiety level.

  It was applied before the intervention was performed when the cervical opening was 4 cm.

• post-intervention anxiety at the start of the active phase was assessed by Visual Analogue Scale-Anxiety (VAS-A)

  The scale is a 10 cm ruler representing the absence of anxiety (0 = no anxiety) at one end and the most severe anxiety (10 = severe anxiety) at the other end. The patient is asked to put a line or mark on the area showing the level of anxiety. The part from the no anxiety point to the point marked by the patient is measured in mm and the value found indicates the patient's anxiety level.

  It was applied after the intervention was performed when the cervical opening was 4 cm.

• pre-intervention pain at the start of the transition phase was assessed by Visual Analogue Scale-Pain (VAS-P)

  The scale is a 10 cm ruler that represents painlessness at one end (0=no pain) and the most severe pain (10=severe pain) at the other end. The patient is asked to put a line or mark on the point representing the intensity of pain. The part from the "no pain" point to the point marked by the participant is measured in mm and the value found indicates the patient's pain level.

  It was applied before the intervention was performed when the cervical opening was 8 cm.

• post-intervention pain at the start of the transition phase was assessed by Visual Analogue Scale-Pain (VAS-P)

  The scale is a 10 cm ruler that represents painlessness at one end (0=no pain) and the most severe pain (10=severe pain) at the other end. The patient is asked to put a line or mark on the point representing the intensity of pain. The part from the "no pain" point to the point marked by the participant is measured in mm and the value found indicates the patient's pain level.

  It was applied after the intervention was performed when the cervical opening was 8 cm.

• pre-intervention anxiety at the start of the transition phase was assessed by Visual Analogue Scale-Anxiety (VAS-A)

  The scale is a 10 cm ruler representing the absence of anxiety (0 = no anxiety) at one end and the most severe anxiety (10 = severe anxiety) at the other end. The patient is asked to put a line or mark on the area showing the level of anxiety. The part from the no anxiety point to the point marked by the patient is measured in mm and the value found indicates the patient's anxiety level.

  It was applied before the intervention was performed when the cervical opening was 8 cm.

• post-intervention anxiety at the start of the transition phase was assessed by Visual Analogue Scale-Anxiety (VAS-A)

  The scale is a 10 cm ruler representing the absence of anxiety (0 = no anxiety) at one end and the most severe anxiety (10 = severe anxiety) at the other end. The patient is asked to put a line or mark on the area showing the level of anxiety. The part from the no anxiety point to the point marked by the patient is measured in mm and the value found indicates the patient's anxiety level.

  It was applied after the intervention was performed when the cervical opening was 8 cm.

• birth perception in the postpartum period was assessed by Mother's Perception of Birth Scale

  The Mother's Perception of Birth Scale, which evaluates the experiences and perceptions of mothers at the time of birth, was developed by Fawcett and Knauth (144). The Turkish validity and reliability study of the scale was carried out by Güngör and Beji (2007). Experiences at the time of birth (7 items; 3, 5, 6, 8, 15, 17, 18), experiences during the pain period of labor (7 items; 1, 2, 4, 7, 9, 10, 16), postpartum (4 items) It consists of a total of 5 sub-dimensions and 25 items, namely; 22, 23, 24, 25), partner involvement (4 items; 11,12,20,21) and awareness (3 items; 13,14,19). Each item is scored from 1 to 5 in the Mother's Perception of Birth Scale. It is evaluated as 1-Not at all, 2-A little, 3-Moderate, 4-Very, 5-Very much. Since the questions 15-16-17-18-19 of the scale contain negative statements, scoring is done in reverse for these questions.

  postpartum 4 hour

Secondary Outcomes (32)

• pre-intervention systolic blood pressure (mmHg) at the start of the active phase was assessed.

  It was applied before the intervention was performed when the cervical opening was 4 cm.

• post-intervention systolic blood pressure (mmHg) at the start of the active phase was assessed.

  It was applied after the intervention was performed when the cervical opening was 4 cm.

• pre-intervention diastolic blood pressure (mmHg) at the start of the active phase was assessed.

  It was applied before the intervention was performed when the cervical opening was 4 cm.

• post-intervention diastolic blood pressure (mmHg) at the start of the active phase was assessed.

  It was applied after the intervention was performed when the cervical opening was 4 cm.

• pre-intervention pulse (minute) at the start of the active phase was assessed.

  It was applied before the intervention was performed when the cervical opening was 4 cm.

Study Arms (2)

Standard of care

NO INTERVENTION

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.

Standard of care+ virtual reality glasses

EXPERIMENTAL

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.

Other: Standard of care+virtual reality glasses

Interventions

Standard of care+virtual reality glasses OTHER

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

Standard of care+ virtual reality glasses

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: The study was carried out with women in accordance with the subject of the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

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

Bolu, Center, 14280, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39749486 DERIVED

MeSH Terms

Conditions

Labor Pain; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Mervenur BÖYÜK

  Baibu

  PRINCIPAL INVESTIGATOR

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: Research Assistant

Model Details: Randomized controlled experimental research

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: August 10, 2022
• Study Start: June 21, 2021
• Primary Completion: December 12, 2021
• Study Completion: December 12, 2021
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

TU (1)