Virtual Reality, Labor Pain, Anxiety, Birth Perception

Anxiety Clinical Trial

Official title:

Birth Journey Through Virtual Reality :Pain, Anxiety and Birth Perception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05495009
• Other study ID #: IBDH-KDÜ-MB-01
• Status: Completed
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: December 12, 2021

Study information

• Verified date: August 2022
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 12, 2021
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Labor Pain

Intervention

Other:
• Standard of care+virtual reality glasses
At the beginning of the active and transitional phases of labor, videos were watched with virtual reality glasses.

Locations

Country	Name	City	State
Turkey	Izzet Baysal State Hospital, Obstetrics and Pediatrics Unit, delivery room service	Bolu	Center

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	pre-intervention systolic blood pressure (mmHg) at the start of the active phase was assessed.	systolic blood pressure, measures the pressure in your arteries when your heart beats. Measurements were made with a blood pressure monitor.	It was applied before the intervention was performed when the cervical opening was 4 cm.
Secondary	post-intervention systolic blood pressure (mmHg) at the start of the active phase was assessed.	systolic blood pressure, measures the pressure in your arteries when your heart beats. Measurements were made with a blood pressure monitor.	It was applied after the intervention was performed when the cervical opening was 4 cm.
Secondary	pre-intervention diastolic blood pressure (mmHg) at the start of the active phase was assessed.	diastolic blood pressure, measures the pressure in your arteries when your heart rests between beats. Measurements were made with a blood pressure monitor.	It was applied before the intervention was performed when the cervical opening was 4 cm.
Secondary	post-intervention diastolic blood pressure (mmHg) at the start of the active phase was assessed.	diastolic blood pressure, measures the pressure in your arteries when your heart rests between beats. Measurements were made with a blood pressure monitor.	It was applied after the intervention was performed when the cervical opening was 4 cm.
Secondary	pre-intervention pulse (minute) at the start of the active phase was assessed.	The rhythmic dilation of an artery that results from beating of the heart. Measurements were made with a heart rate monitor.	It was applied before the intervention was performed when the cervical opening was 4 cm.
Secondary	post-intervention pulse (minute) at the start of the active phase was assessed.	The rhythmic dilation of an artery that results from beating of the heart. Measurements were made with a heart rate monitor.	It was applied after the intervention was performed when the cervical opening was 4 cm.
Secondary	pre-intervention respiration (minute) at the start of the active phase was assessed.	the inhaling of oxygen and the exhaling of carbon dioxide. is found by counting the number of breaths (how many times the chest rises).	It was applied before the intervention was performed when the cervical opening was 4 cm.
Secondary	post-intervention respiration (minute) at the start of the active phase was assessed.	the inhaling of oxygen and the exhaling of carbon dioxide. is found by counting the number of breaths (how many times the chest rises).	It was applied after the intervention was performed when the cervical opening was 4 cm.
Secondary	pre-intervention fetal heart rate (minute) at the start of the active phase was assessed.	Fetal heart rate was measured using a fetal Doppler device.	It was applied before the intervention was performed when the cervical opening was 4 cm.
Secondary	post-intervention fetal heart rate (minute) at the start of the active phase was assessed.	Fetal heart rate was measured using a fetal Doppler device.	It was applied after the intervention was performed when the cervical opening was 4 cm.
Secondary	pre-intervention contraction frequency (minute) at the start of the active phase was assessed.	Measurements were made using the NST device.	It was applied before the intervention was performed when the cervical opening was 4 cm.
Secondary	post-intervention contraction frequency (minute) at the start of the active phase was assessed.	Measurements were made using the NST device.	It was applied after the intervention was performed when the cervical opening was 4 cm.
Secondary	pre-intervention contraction duration (minute) at the start of the active phase was assessed.	Measurements were made using the NST device.	It was applied before the intervention was performed when the cervical opening was 4 cm.
Secondary	post-intervention contraction duration (minute) at the start of the active phase was assessed.	Measurements were made using the NST device.	It was applied after the intervention was performed when the cervical opening was 4 cm.
Secondary	pre-intervention contraction severity (minute) at the start of the active phase was assessed.	Measurements were made using the NST device.	It was applied before the intervention was performed when the cervical opening was 4 cm.
Secondary	post-intervention contraction severity (minute) at the start of the active phase was assessed.	Measurements were made using the NST device.	It was applied after the intervention was performed when the cervical opening was 4 cm.
Secondary	pre-intervention systolic blood pressure (mmHg) at the start of the transition phase was assessed.	systolic blood pressure, measures the pressure in your arteries when your heart beats. Measurements were made with a blood pressure monitor.	It was applied before the intervention was performed when the cervical opening was 8 cm.
Secondary	post-intervention systolic blood pressure (mmHg) at the start of the transition phase was assessed.	systolic blood pressure, measures the pressure in your arteries when your heart beats. Measurements were made with a blood pressure monitor.	It was applied after the intervention was performed when the cervical opening was 8 cm.
Secondary	pre-intervention diastolic blood pressure (mmHg) at the start of the transition phase was assessed.	diastolic blood pressure, measures the pressure in your arteries when your heart rests	It was applied before the intervention was performed when the cervical opening was 8 cm.
Secondary	post-intervention diastolic blood pressure (mmHg) at the start of the transition phase was assessed.	diastolic blood pressure, measures the pressure in your arteries when your heart rests	It was applied after the intervention was performed when the cervical opening was 8 cm.
Secondary	pre-intervention pulse (minute) at the start of the transition phase was assessed.	The rhythmic dilation of an artery that results from beating of the heart. Measurements were made with a heart rate monitor.	It was applied before the intervention was performed when the cervical opening was 8 cm.
Secondary	post-intervention pulse (minute) at the start of the transition phase was assessed.	The rhythmic dilation of an artery that results from beating of the heart. Measurements were made with a heart rate monitor.	It was applied after the intervention was performed when the cervical opening was 8 cm.
Secondary	pre-intervention respiration (minute) at the start of the transition phase was assessed.	the inhaling of oxygen and the exhaling of carbon dioxide. is found by counting the number of breaths (how many times the chest rises).	It was applied before the intervention was performed when the cervical opening was 8 cm.
Secondary	post-intervention respiration (minute) at the start of the transition phase was assessed.	the inhaling of oxygen and the exhaling of carbon dioxide. is found by counting the number of breaths (how many times the chest rises).	It was applied after the intervention was performed when the cervical opening was 8 cm.
Secondary	pre-intervention fetal heart rate (minute) at the start of the transition phase was assessed.	Fetal heart rate was measured using a fetal Doppler device.	It was applied before the intervention was performed when the cervical opening was 8 cm.
Secondary	post-intervention fetal heart rate (minute) at the start of the transition phase was assessed.	Fetal heart rate was measured using a fetal Doppler device.	It was applied after the intervention was performed when the cervical opening was 8 cm.
Secondary	pre-intervention contraction frequency (minute) at the start of the transition phase was assessed.	Measurements were made using the NST device.	It was applied before the intervention was performed when the cervical opening was 8 cm.
Secondary	post-intervention contraction frequency (minute) at the start of the transition phase was assessed.	Measurements were made using the NST device.	It was applied after the intervention was performed when the cervical opening was 8 cm.
Secondary	pre-intervention contraction duration (minute) at the start of the transiton phase was assessed.	Measurements were made using the NST device.	It was applied before the intervention was performed when the cervical opening was 8 cm.
Secondary	post-intervention contraction duration (minute) at the start of the transiton phase was assessed.	Measurements were made using the NST device.	It was applied after the intervention was performed when the cervical opening was 8 cm.
Secondary	pre-intervention contraction severity (minute) at the start of the transition phase was assessed.	Measurements were made using the NST device.	It was applied before the intervention was performed when the cervical opening was 8 cm.
Secondary	post-intervention contraction severity (minute) at the start of the transition phase was assessed.	Measurements were made using the NST device.	It was applied after the intervention was performed when the cervical opening was 8 cm.