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Labor PainNCT05527236

The Effects of Breathing Exercises and Virtual Reality Applications During Pregnancy and Labor.

A study testing Breathing Exercise and Virtual Reality in people with Labor Pain and Labor Onset, run by Semra Çevik, phD at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aim and Objectives: The purpose of this study was to determine the effects of breathing exercises and virtual reality applications during pregnancy and labor on labor pain, duration, and birth satisfaction. Background: Conducted studies show that practices such as virtual reality have positive effects on labor. Read more about this study

Who is it for?
Ages 19 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Pain, Labor Onset, Patient Satisfaction
What is being tested?
Breathing Exercise and Virtual Reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Oct 2020to 1 May 2022
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 19 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • In the 36th week of pregnancy,
  • Those who gave birth at 40 weeks of gestation,
  • Those who will have a normal (vaginal) birth,
  • Primiparas,
  • 19 years old and over,
  • Able to communicate verbally,
Show all 9Show fewer
  • Who agreed to participate in the study,
  • Those who can read and write,
  • Those who have COVID-19 test negative, no contact or doubt.

Who cannot join

  • Have no risks regarding the pregnant woman and fetus,
  • Multiparous,
  • Those who underwent cesarean section,
  • Having visual or auditory impairment,
  • Having any infection in the mouth,
  • Having any contagious eye disease,
  • Those administered analgesics during labour,
  • Those who have COVID-19 test positive, contact or doubt.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital

    Gaziantep

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Breathing Exercises and Virtual Reality Applications During Pregnancy and Labor on Labor Pain, Duration, and Birth Satisfaction: A Randomized Controlled Study

Aim and Objectives: The purpose of this study was to determine the effects of breathing exercises and virtual reality applications during pregnancy and labor on labor pain, duration, and birth satisfaction.

Background: Conducted studies show that practices such as virtual reality have positive effects on labor. However, there is no study that compares the effects of breathing exercises with virtual reality applications on labor.

Read more

Design: A randomized controlled experiment was conducted by the CONSORT guidelines.

Methods: The study included 114 pregnant women (Breathing Exercise Group:39, Virtual Reality Group:37, Control Group:38). The research was carried out in two stages. In the first stage, for the experimental groups at the 36th-39th weeks of pregnancy, a 10-minute breathing exercise was performed 3 times a week using virtual reality glasses and a breathing exercise device. In the second stage of the study (when the cervical dilatation was 4 cm), the breathing exercise group was made breathing exercises again. The virtual reality group watched a 10-minute video with virtual reality glasses. Once the virtual reality glasses were removed from experimental groups Visual Analogue Scale was applied. Birth satisfaction was evaluated with the Birth Satisfaction Scale within the first 4 hours after the delivery was completed.

Read the detailed description
  1. INTRODUCTION Management of labor pain and increasing the birth satisfaction level of the expectant mother are the main goals of prenatal and postpartum care (Huntley, Coon, \& Ernest, 2004). For this purpose, two kinds of methods, which are pharmacological and non-pharmacological are used (Vulkan, \& Yıldız, 2016). One of the non-pharmacological applications is virtual reality technology (Dockx et al., 2016; Ebrahimian, \& Bilandi, 2022). Another non-pharmacological application in pregnancy and labor is breathing exercises (Dikmen, \& Sanlı, 2019).
  2. MATERIAL AND METHODS Study design The researchers carried out this study between October 2020 and January 2022 in the pregnant outpatient clinic and in the delivery room, at the maternity hospital in southeastern Anatolia, Turkey.

Study population The sample of the study consisted of all pregnant women who applied to the pregnancy polyclinic for normal delivery. The sample size of the study was calculated as 63 pregnant women including 21 participants in each group using the G*Power Software version 3.9.1 with the VAS mean scores in the study by Dutucu (2019) as 5.63 (SD = 1.07), and obtaining a rate of 80% in the power test, an alpha value of 0.05 with a 95% confidence level (Dutucu, 2019). However, we decided to include 40 pregnant women in each group in order to be able to generalize and strengthen the research results. The study reached 120 pregnant women. Five pregnant women did not meet the inclusion criteria and one pregnant woman withdraw from the study during the process and was excluded from the study. Eventually, the study sample was composed of 114 pregnant women based on the CONSORT 2010 flow diagram: 39 in the breathing exercise group, 37 participants in the virtual reality group, and 38 in the control group.

Randomization Pregnant women were randomly selected via a drawing, and they were assigned to either the experimental or control group. For the drawing of lots; 120 small papers were prepared, and the words 'virtual', 'breathing', and 'control' were written on every 40 papers, and they were folded and put into a bag. The inclusion of pregnant into groups was determined according to the papers pregnant drew from the bag. Pregnant women participating in the study did not know how many groups are available and which method will be applied to the group in which they are selected. We carried out this study with three groups, one control, and two experiments. The experimental group is divided into two groups, the breathing exercise group, and the virtual reality group.

Data Collection Tools The data of the study were collected by using "Descriptive Information Form", "Labour Observation Form", "Visual Analog Scale ", and "Birth Satisfaction Scale".

Collection of data The First Stage of The Research As mentioned before, this step was applied in the same way for both experimental groups. The descriptive information form was filled in by the pregnant women under the supervision of the researchers. At the 36th gestational week, the pregnant women were informed that they should not eat or drink anything 1 hour before the exercise. In addition, we gave the necessary information to the participants about virtual reality and breathing exercise devices together with how they would be applied and what video content they would watch. A 10-minute(5 minutes of breathing exercise and 5 minutes of relaxation exercise at the end of the exercise) breathing exercise video was shown to the participants using virtual reality glasses. At the same time, the participants were asked to do the breathing exercises shown in the video using the breathing exercise device. This application was performed 3 times a week from the 36th gestational week to the 40th gestational week, and 12 times in total until birth.

All applications were carried out in a quiet, calm pregnant outpatient clinic in the hospital, and a cushion on which the pregnant woman could sit and a pillow that could support her back were used to ensure the comfort of the pregnant woman.

The Second Stage of The Research After the first stage of the research was applied to the experimental groups, the second stage was carried out during the delivery at the 40th week of pregnancy. The second stage was applied in a different way for the Breathing Exercise Group and Virtual Reality Group. In the following sections, the second stage is explained for both groups.

Breathing Exercise Group Participants after being admitted to the delivery room of Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital and taken to their beds, the labor evaluation section of the labor observation form was filled. Firstly the pregnant women were placed in the semi-fowler position and virtual reality glasses with a breathing exercise device were put on when the cervical dilatation was 4 cm (the beginning of the active phase). A 10-minute (5 minutes of breathing exercise and 5 minutes of relaxation exercise at the end of the exercise) breathing exercise video was shown to the participants using virtual reality glasses. At the same time, the participants were asked to do the breathing exercises shown in the video using the breathing exercise device. As soon as the virtual reality glasses and breathing exercise device were removed, VAS was applied. In order to evaluate the second and third stages of labor, the birth evaluation section of the labor observation form was filled out. Satisfaction with birth was evaluated with the ''Birth Satisfaction Scale'' within the first 4 hours after birth after the delivery was completed.

Virtual Reality Group Participants after being admitted to the delivery room of Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital and taken to their beds, the labor evaluation section of the labor observation form was filled. Firstly the pregnant women were placed in the semi-fowler position and virtual reality glasses were put on when the cervical dilatation was 4 cm (the beginning of the active phase). Then, in virtual reality glasses, a 10-minute relaxing video of the chirping of birds, calm sea, colorful birds, sunrise, sunset, colorful flowers, and trees was played accompanied by the background music called ''Dancing With Nature'' by Tim Janis. Once the virtual reality glasses were removed VAS was applied. In order to evaluate the second and third stages of labor, the birth evaluation part of the labor observation form was filled out. Birth satisfaction was evaluated with the ''Birth Satisfaction Scale'' within the first 4 hours after the delivery was completed.

Control Group A descriptive information form was filled out at the 36th week of pregnancy in a quiet pregnant outpatient clinic in the hospital. After participants were admitted to the delivery room of Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital at the 40th week of pregnancy, and taken to their beds, in labor observation form, the labor section and the birth evaluation section which are used to evaluate the second and third stages of labor were filled out. Then, VAS was applied when cervical dilatation was 4 cm (the beginning of the active phase). Birth satisfaction was evaluated with the ''Birth Satisfaction Scale'' within the first 4 hours after birth after the delivery was completed.

No application was made to pregnant women in this group, except for routine practices in the pregnant outpatient clinic at the hospital and in the delivery room.

Being tested
Breathing Exercise, Virtual Reality
Keywords
breathing exercises, virtual reality, pain intensity, duration of labor, birth satisfaction
Medical subject headings
Labor Pain, Patient Satisfaction, Respiratory Aspiration, Tics, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breathing ExerciseOther

    The research was carried out in two stages. In the first stage, for the experimental groups at the 36th-39th weeks of pregnancy, a 10-minute breathing exercise was performed 3 times a week using virtual reality glasses and a breathing exercise device. In the second stage of the study (when the cervical dilatation was 4 cm), the breathing exercise group was made breathing exercises again. As soon as the virtual reality glasses and breathing exercise device were removed, VAS was applied. In order to evaluate the second and third stages of labor, the birth evaluation section of the labor observation form was filled out. Satisfaction with birth was evaluated with the ''Birth Satisfaction Scale'' within the first 4 hours after birth after the delivery was completed.

  • Virtual RealityOther

    The research was carried out in two stages. In the first stage, for the experimental groups at the 36th-39th weeks of pregnancy, a 10-minute breathing exercise was performed 3 times a week using virtual reality glasses and a breathing exercise device. In the second stage of the study (when the cervical dilatation was 4 cm) the virtual reality group watched a 10-minute video with virtual reality glasses. Once the virtual reality glasses were removed from experimental groups Visual Analogue Scale was applied. Birth satisfaction was evaluated with the Birth Satisfaction Scale within the first 4 hours after the delivery was completed.

Study groups in NCT05527236
Study groupRoleWhat they receive
Breathing Exercise GroupExperimentalThe research was carried out in two stages. In the first stage, for the experimental groups at the 36th-39th weeks of pregnancy, a 10-minute breathing exercise was performed 3 times a week using virtual reality glasses and a breathing exercise device. In the second stage of the study (when the cervical dilatation was 4 cm), the breathing exercise group was made breathing exercise again. As soon as the virtual reality glasses and breathing exercise device were removed, VAS was applied. In order to evaluate the second and third stages of labor, the birth evaluation section of the labor observation form was filled out. Satisfaction with birth was evaluated with the ''Birth Satisfaction Scale'' within the first 4 hours after birth after the delivery was completed.
Receives: Other: Breathing Exercise
Virtual Reality GroupExperimentalThe research was carried out in two stages. In the first stage, for the experimental groups at the 36th-39th weeks of pregnancy, a 10-minute breathing exercise was performed 3 times a week using virtual reality glasses and a breathing exercise device. In the second stage of the study (when the cervical dilatation was 4 cm), the virtual reality group watched a 10-minute video with virtual reality glasses. Once the virtual reality glasses were removed from experimental groups Visual Analogue Scale was applied. Birth satisfaction was evaluated with the Birth Satisfaction Scale within the first 4 hours after the delivery was completed.
Receives: Other: Virtual Reality
Control GroupNo interventionDescriptive information form was filled out at 36th week of pregnancy in a quiet pregnant outpatient clinic in the hospital. After participants were admitted to the delivery room of Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital at the 40th week of pregnancy, and taken to their beds, in labour observation form, the labour section and the birth evaluation section which is used to evaluate the second and third stages of labour were filled out. Then, VAS was applied when cervical dilatation was 4 cm (the beginning of the active phase). Birth satisfaction was evaluated with the ''Birth Satisfaction Scale'' within the first 4 hours after birth after the delivery was completed. No application was made to pregnant women in this group, except for routine practices in the pregnant outpatient clinic at the hospital and in the delivery room.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ''Labor pain''

    Labor pain was evaluated with the Visual Analogue Scale (VAS).

    Measured: ''1 minute later''

Secondary outcomes (2)
  1. ''Duration of labor''

    Duration of labor was evaluated with the Labour Observation Form.

    Measured: ''within the first 10 hours''

  2. ''Birth satisfaction''

    Birth satisfaction was evaluated with the Birth Satisfaction Scale.

    Measured: ''within the first 4 hours''

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2022
  2. Study start15 Oct 2020
  3. Primary completion15 Jan 2022
  4. Study completion1 May 2022

Resources

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
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05527236
Sponsor's protocol ID
Virtual Breathing
Status last verified
May 2023
First submitted
30 Aug 2022
Last updated
10 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Breathing Exercise and Virtual Reality in people with Labor Pain and Labor Onset, run by Semra Çevik, phD 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 9 inclusion and 8 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 May 2023. 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?

''Labor pain'' (time frame: ''1 minute later''). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 May 2023.

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