Labor PainNCT05495009
Virtual Reality, Labor Pain, Anxiety, Birth Perception
A study of Labor Pain and Anxiety, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Anxiety
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jun 2021to 12 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzzet Baysal State Hospital, Obstetrics and Pediatrics Unit, delivery room service
Bolu, Center, 14280
About this study
Official title: Birth Journey Through Virtual Reality :Pain, Anxiety and Birth Perception
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.
Read the 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.
- Conditions
- Labor Pain, Anxiety
- Being tested
- Standard of care+virtual reality glasses
- Keywords
- labor, pain, anxiety, birth perception, virtual reality
- Medical subject headings
- Labor Pain, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care+virtual reality glassesOther
At the beginning of the active and transitional phases of labor, videos were watched with virtual reality glasses.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard of care+virtual reality glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: postpartum 4 hour
Secondary outcomes (32)
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.
Measured: 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.
systolic blood pressure, measures the pressure in your arteries when your heart beats. Measurements were made with a blood pressure monitor.
Measured: 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.
diastolic blood pressure, measures the pressure in your arteries when your heart rests between beats. Measurements were made with a blood pressure monitor.
Measured: 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.
diastolic blood pressure, measures the pressure in your arteries when your heart rests between beats. Measurements were made with a blood pressure monitor.
Measured: 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.
The rhythmic dilation of an artery that results from beating of the heart. Measurements were made with a heart rate monitor.
Measured: It was applied before the intervention was performed when the cervical opening was 4 cm.
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.
Measured: It was applied after the intervention was performed when the cervical opening was 4 cm.
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).
Measured: It was applied before the intervention was performed when the cervical opening was 4 cm.
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).
Measured: It was applied after the intervention was performed when the cervical opening was 4 cm.
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.
Measured: It was applied before the intervention was performed when the cervical opening was 4 cm.
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.
Measured: It was applied after the intervention was performed when the cervical opening was 4 cm.
pre-intervention contraction frequency (minute) at the start of the active phase was assessed.
Measurements were made using the NST device.
Measured: It was applied before the intervention was performed when the cervical opening was 4 cm.
post-intervention contraction frequency (minute) at the start of the active phase was assessed.
Measurements were made using the NST device.
Measured: It was applied after the intervention was performed when the cervical opening was 4 cm.
pre-intervention contraction duration (minute) at the start of the active phase was assessed.
Measurements were made using the NST device.
Measured: It was applied before the intervention was performed when the cervical opening was 4 cm.
post-intervention contraction duration (minute) at the start of the active phase was assessed.
Measurements were made using the NST device.
Measured: It was applied after the intervention was performed when the cervical opening was 4 cm.
pre-intervention contraction severity (minute) at the start of the active phase was assessed.
Measurements were made using the NST device.
Measured: It was applied before the intervention was performed when the cervical opening was 4 cm.
post-intervention contraction severity (minute) at the start of the active phase was assessed.
Measurements were made using the NST device.
Measured: It was applied after the intervention was performed when the cervical opening was 4 cm.
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.
Measured: It was applied before the intervention was performed when the cervical opening was 8 cm.
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.
Measured: It was applied after the intervention was performed when the cervical opening was 8 cm.
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
Measured: It was applied before the intervention was performed when the cervical opening was 8 cm.
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
Measured: It was applied after the intervention was performed when the cervical opening was 8 cm.
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.
Measured: It was applied before the intervention was performed when the cervical opening was 8 cm.
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.
Measured: It was applied after the intervention was performed when the cervical opening was 8 cm.
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).
Measured: It was applied before the intervention was performed when the cervical opening was 8 cm.
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).
Measured: It was applied after the intervention was performed when the cervical opening was 8 cm.
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.
Measured: It was applied before the intervention was performed when the cervical opening was 8 cm.
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.
Measured: It was applied after the intervention was performed when the cervical opening was 8 cm.
pre-intervention contraction frequency (minute) at the start of the transition phase was assessed.
Measurements were made using the NST device.
Measured: It was applied before the intervention was performed when the cervical opening was 8 cm.
post-intervention contraction frequency (minute) at the start of the transition phase was assessed.
Measurements were made using the NST device.
Measured: It was applied after the intervention was performed when the cervical opening was 8 cm.
pre-intervention contraction duration (minute) at the start of the transiton phase was assessed.
Measurements were made using the NST device.
Measured: It was applied before the intervention was performed when the cervical opening was 8 cm.
post-intervention contraction duration (minute) at the start of the transiton phase was assessed.
Measurements were made using the NST device.
Measured: It was applied after the intervention was performed when the cervical opening was 8 cm.
pre-intervention contraction severity (minute) at the start of the transition phase was assessed.
Measurements were made using the NST device.
Measured: It was applied before the intervention was performed when the cervical opening was 8 cm.
post-intervention contraction severity (minute) at the start of the transition phase was assessed.
Measurements were made using the NST device.
Measured: It was applied after the intervention was performed when the cervical opening was 8 cm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start21 Jun 2021
- Primary completion12 Dec 2021
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled experimental research
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mervenur BÖYÜK, Abant Izzet Baysal University
- Investigators
- Mervenur BÖYÜK, Principal investigator, Baibu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495009
- Sponsor's protocol ID
- İBDH-KDÜ-MB-01
- Status last verified
- Aug 2022
- First submitted
- 6 Jul 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39749486
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Birth Journey Through Virtual Reality :Pain, Anxiety and Birth Perception
- ClinicalTrials.gov ID
- NCT05495009
- Acronym / sponsor ID
- İBDH-KDÜ-MB-01
- Conditions
- Labor Pain, Anxiety
- Keywords
- labor, pain, anxiety, birth perception, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled experimental research
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Standard of care+virtual reality glassesIntroductory 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Able to communicate verbally
- Between the ages of 18-35
- No pregnancy-related risk diagnosis,
- Primiparous,
- Vaginal delivery planned,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care+virtual reality glassesAt the beginning of the active and transitional phases of labor, videos were watched with virtual reality glasses. | Other | Standard of care+ virtual reality glasses |
Primary outcome
pre-intervention pain at the start of the active phase was assessed by Visual Analogue Scale-Pain (VAS-P)
Time frame: It was applied before the intervention was performed when the cervical opening was 4 cm.
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.
post-intervention pain at the start of the active phase was assessed Visual Analogue Scale-Pain (VAS-P)
Time frame: It was applied after the intervention was performed when the cervical opening was 4 cm.
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.
pre-intervention anxiety at the start of the active phase was assessed by Visual Analogue Scale-Anxiety (VAS-A)
Time frame: It was applied before the intervention was performed when the cervical opening was 4 cm.
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.
post-intervention anxiety at the start of the active phase was assessed by Visual Analogue Scale-Anxiety (VAS-A)
Time frame: It was applied after the intervention was performed when the cervical opening was 4 cm.
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.
pre-intervention pain at the start of the transition phase was assessed by Visual Analogue Scale-Pain (VAS-P)
Time frame: It was applied before the intervention was performed when the cervical opening was 8 cm.
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.
post-intervention pain at the start of the transition phase was assessed by Visual Analogue Scale-Pain (VAS-P)
Time frame: It was applied after the intervention was performed when the cervical opening was 8 cm.
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.
pre-intervention anxiety at the start of the transition phase was assessed by Visual Analogue Scale-Anxiety (VAS-A)
Time frame: It was applied before the intervention was performed when the cervical opening was 8 cm.
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.
post-intervention anxiety at the start of the transition phase was assessed by Visual Analogue Scale-Anxiety (VAS-A)
Time frame: It was applied after the intervention was performed when the cervical opening was 8 cm.
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.
birth perception in the postpartum period was assessed by Mother's Perception of Birth Scale
Time frame: postpartum 4 hour
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.
32 secondary outcomes
pre-intervention systolic blood pressure (mmHg) at the start of the active phase was assessed.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: It was applied before the intervention was performed when the cervical opening was 4 cm.
post-intervention pulse (minute) at the start of the active phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 4 cm.
pre-intervention respiration (minute) at the start of the active phase was assessed.
Time frame: It was applied before the intervention was performed when the cervical opening was 4 cm.
post-intervention respiration (minute) at the start of the active phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 4 cm.
pre-intervention fetal heart rate (minute) at the start of the active phase was assessed.
Time frame: It was applied before the intervention was performed when the cervical opening was 4 cm.
post-intervention fetal heart rate (minute) at the start of the active phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 4 cm.
pre-intervention contraction frequency (minute) at the start of the active phase was assessed.
Time frame: It was applied before the intervention was performed when the cervical opening was 4 cm.
post-intervention contraction frequency (minute) at the start of the active phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 4 cm.
pre-intervention contraction duration (minute) at the start of the active phase was assessed.
Time frame: It was applied before the intervention was performed when the cervical opening was 4 cm.
post-intervention contraction duration (minute) at the start of the active phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 4 cm.
pre-intervention contraction severity (minute) at the start of the active phase was assessed.
Time frame: It was applied before the intervention was performed when the cervical opening was 4 cm.
post-intervention contraction severity (minute) at the start of the active phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 4 cm.
pre-intervention systolic blood pressure (mmHg) at the start of the transition phase was assessed.
Time frame: It was applied before the intervention was performed when the cervical opening was 8 cm.
post-intervention systolic blood pressure (mmHg) at the start of the transition phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 8 cm.
pre-intervention diastolic blood pressure (mmHg) at the start of the transition phase was assessed.
Time frame: It was applied before the intervention was performed when the cervical opening was 8 cm.
post-intervention diastolic blood pressure (mmHg) at the start of the transition phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 8 cm.
pre-intervention pulse (minute) at the start of the transition phase was assessed.
Time frame: It was applied before the intervention was performed when the cervical opening was 8 cm.
post-intervention pulse (minute) at the start of the transition phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 8 cm.
pre-intervention respiration (minute) at the start of the transition phase was assessed.
Time frame: It was applied before the intervention was performed when the cervical opening was 8 cm.
post-intervention respiration (minute) at the start of the transition phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 8 cm.
pre-intervention fetal heart rate (minute) at the start of the transition phase was assessed.
Time frame: It was applied before the intervention was performed when the cervical opening was 8 cm.
post-intervention fetal heart rate (minute) at the start of the transition phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 8 cm.
pre-intervention contraction frequency (minute) at the start of the transition phase was assessed.
Time frame: It was applied before the intervention was performed when the cervical opening was 8 cm.
post-intervention contraction frequency (minute) at the start of the transition phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 8 cm.
pre-intervention contraction duration (minute) at the start of the transiton phase was assessed.
Time frame: It was applied before the intervention was performed when the cervical opening was 8 cm.
post-intervention contraction duration (minute) at the start of the transiton phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 8 cm.
pre-intervention contraction severity (minute) at the start of the transition phase was assessed.
Time frame: It was applied before the intervention was performed when the cervical opening was 8 cm.
post-intervention contraction severity (minute) at the start of the transition phase was assessed.
Time frame: It was applied after the intervention was performed when the cervical opening was 8 cm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Derived from this study: PubMed 39749486Boyuk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mervenur BÖYÜK principal investigator
Baibu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Labor Pain and Anxiety, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pre-intervention pain at the start of the active phase was assessed by Visual Analogue Scale-Pain (VAS-P) (time frame: It was applied before the intervention was performed when the cervical opening was 4 cm.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.