Clinical trial NCT05495009: Virtual Reality, Labor Pain, Anxiety, Birth Perception
Official title: Birth Journey Through Virtual Reality :Pain, Anxiety and Birth Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Anxiety
Keywords: labor
pain
anxiety
birth perception
virtual reality
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 60
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: Randomized controlled experimental research
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: pre-intervention pain at the start of the active phase was assessed by Visual Analogue Scale-Pain (VAS-P)
timeFrame: It was applied before the intervention was performed when the cervical opening was 4 cm.
measure: post-intervention pain at the start of the active phase was assessed Visual Analogue Scale-Pain (VAS-P)
timeFrame: It was applied after the intervention was performed when the cervical opening was 4 cm.
measure: pre-intervention anxiety at the start of the active phase was assessed by Visual Analogue Scale-Anxiety (VAS-A)
timeFrame: It was applied before the intervention was performed when the cervical opening was 4 cm.
measure: post-intervention anxiety at the start of the active phase was assessed by Visual Analogue Scale-Anxiety (VAS-A)
timeFrame: It was applied after the intervention was performed when the cervical opening was 4 cm.
measure: pre-intervention pain at the start of the transition phase was assessed by Visual Analogue Scale-Pain (VAS-P)
timeFrame: It was applied before the intervention was performed when the cervical opening was 8 cm.
measure: post-intervention pain at the start of the transition phase was assessed by Visual Analogue Scale-Pain (VAS-P)
timeFrame: It was applied after the intervention was performed when the cervical opening was 8 cm.
measure: pre-intervention anxiety at the start of the transition phase was assessed by Visual Analogue Scale-Anxiety (VAS-A)
timeFrame: It was applied before the intervention was performed when the cervical opening was 8 cm.
measure: post-intervention anxiety at the start of the transition phase was assessed by Visual Analogue Scale-Anxiety (VAS-A)
timeFrame: It was applied after the intervention was performed when the cervical opening was 8 cm.
measure: birth perception in the postpartum period was assessed by Mother's Perception of Birth Scale
timeFrame: postpartum 4 hour
Secondary outcomes:
measure: pre-intervention systolic blood pressure (mmHg) at the start of the active phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 4 cm.
measure: post-intervention systolic blood pressure (mmHg) at the start of the active phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 4 cm.
measure: pre-intervention diastolic blood pressure (mmHg) at the start of the active phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 4 cm.
measure: post-intervention diastolic blood pressure (mmHg) at the start of the active phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 4 cm.
measure: pre-intervention pulse (minute) at the start of the active phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 4 cm.
measure: post-intervention pulse (minute) at the start of the active phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 4 cm.
measure: pre-intervention respiration (minute) at the start of the active phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 4 cm.
measure: post-intervention respiration (minute) at the start of the active phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 4 cm.
measure: pre-intervention fetal heart rate (minute) at the start of the active phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 4 cm.
measure: post-intervention fetal heart rate (minute) at the start of the active phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 4 cm.
measure: pre-intervention contraction frequency (minute) at the start of the active phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 4 cm.
measure: post-intervention contraction frequency (minute) at the start of the active phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 4 cm.
measure: pre-intervention contraction duration (minute) at the start of the active phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 4 cm.
measure: post-intervention contraction duration (minute) at the start of the active phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 4 cm.
measure: pre-intervention contraction severity (minute) at the start of the active phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 4 cm.
measure: post-intervention contraction severity (minute) at the start of the active phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 4 cm.
measure: pre-intervention systolic blood pressure (mmHg) at the start of the transition phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 8 cm.
measure: post-intervention systolic blood pressure (mmHg) at the start of the transition phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 8 cm.
measure: pre-intervention diastolic blood pressure (mmHg) at the start of the transition phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 8 cm.
measure: post-intervention diastolic blood pressure (mmHg) at the start of the transition phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 8 cm.
measure: pre-intervention pulse (minute) at the start of the transition phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 8 cm.
measure: post-intervention pulse (minute) at the start of the transition phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 8 cm.
measure: pre-intervention respiration (minute) at the start of the transition phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 8 cm.
measure: post-intervention respiration (minute) at the start of the transition phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 8 cm.
measure: pre-intervention fetal heart rate (minute) at the start of the transition phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 8 cm.
measure: post-intervention fetal heart rate (minute) at the start of the transition phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 8 cm.
measure: pre-intervention contraction frequency (minute) at the start of the transition phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 8 cm.
measure: post-intervention contraction frequency (minute) at the start of the transition phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 8 cm.
measure: pre-intervention contraction duration (minute) at the start of the transiton phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 8 cm.
measure: post-intervention contraction duration (minute) at the start of the transiton phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 8 cm.
measure: pre-intervention contraction severity (minute) at the start of the transition phase was assessed.
timeFrame: It was applied before the intervention was performed when the cervical opening was 8 cm.
measure: post-intervention contraction severity (minute) at the start of the transition phase was assessed.
timeFrame: It was applied after the intervention was performed when the cervical opening was 8 cm.
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: İzzet Baysal State Hospital, Obstetrics and Pediatrics Unit, delivery room service
state: Center
Study officials:
affiliation: Baibu
name: Mervenur BÖYÜK
role: PRINCIPAL_INVESTIGATOR
References: