Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05527236 |
| Other study ID # |
Virtual Breathing |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2020 |
| Est. completion date |
May 1, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
University of Gaziantep |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. However, there is no study that compares the effects of breathing exercises
with virtual reality applications on labor.
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.
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.
