Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05420883 |
| Other study ID # |
d5uaw8rc |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2022 |
| Est. completion date |
December 15, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Ondokuz Mayis University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Fetal death accounts for approximately half of perinatal death. Fetal health should be
evaluated in order to identify fetuses at risk of intrauterine death and to prevent perinatal
morbidity and mortality. The Nonstress test, which is used to evaluate fetal health, is an
important issue as it provides health professionals with information about fetal health. The
research was planned as a randomized controlled trial to examine the effect of acupressure
and halogen light stimulation on nonstress testing and anxiety of the pregnant woman. The
research is planned to be conducted in the nonstress test room of the Obstetrics and
Gynecology outpatient clinic of Samsun Training and Research Hospital Gynecology and
Childhood Diseases Hospital between May 2021 and June 2023. The sample size of the study was
calculated by power analysis (G*Power 3.1.9.2 program was used) and a total of 120 pregnant
women were found. In order to increase the analysis power of the research, the number of
samples was increased by 20% and it was decided to have at least 144 pregnant women
(acupressure group: 48; halogen light group: 48 and control group: 48) for the study. The
data of the study will be collected with the Pregnant Identification Form, the Nonstress Test
Follow-up Form and the State Anxiety Scale. The data of the study will be evaluated using the
SPSS 24 deviation, median and minimum-maximum values will be given. Chi-square test, Student
t test, ANOVA test for those with normal distribution, Mann-Whitney U and Kruskal Wallis
tests for those who are not.
Description:
H01: There was no difference between the nonstress test results of pregnant women who
received acupressure and control group pregnant women.
H02: There was no difference between the anxiety levels of the pregnant women who received
acupressure and the control group pregnant women.
H03: There is no difference between the nonstress test results of the pregnant women who
received halogen light stimulation and the control group pregnant women.
H04: There was no difference between the anxiety levels of pregnant women who received
halogen light stimulation and those in the control group.
H05: There is no difference between the nonstress test results of pregnant women who received
acupressure and halogen light stimulation.
H06: There was no difference between the anxiety levels of pregnant women who received
acupressure and halogen light stimulation.
This study was designed as a randomized controlled experimental study. The research will be
carried out between May 2021 and June 2023 in the Nonstress test room in the obstetrics and
gynecology outpatient clinic of Samsun Training and Research Hospital Gynecology and
Childhood Diseases Hospital affiliated to Samsun Provincial Health Directorate. The universe
of the study will be composed of pregnant women who applied to the Nonstress test room for
Nonstress test extraction after having a pregnancy follow-up in the obstetrics and gynecology
outpatient clinic of Samsun Training and Research Hospital. The sample of the study will be
divided into three groups as acupressure group, halogen light group and control group.
The sample size of the study, according to the power analysis (G*Power 3.1.9.2 program was
used) using the values of Rahimikian et al.'s (2013) studies, at least 40 people for each
group (acupressure group: 40) with 80% power and 5% margin of error. ; halogen light group:
40 and control group: 40), a total of 120 pregnant women were calculated. In order to
increase the analysis power of the research, the number of samples was increased by 20% and
it was decided to have at least 144 pregnant women (acupressure group: 48; halogen light
group: 48 and control group: 48) for the study. A layer will be formed in terms of age,
number of pregnancies and gestational week of the pregnant women in the acupressure group,
halogen light group and control group, and a homogeneous distribution of the groups will be
ensured. Which group the participants will be in will be determined by the full randomization
technique on the website www.randomizer.org. After obtaining permission from the ethics
committee and the institution that will carry out the study, the pregnant women will go to
the institution. Pregnant women who meet the research criteria will be informed about the
purpose, content and method of the research, and verbal and written consent will be obtained
from those who want to participate. The researcher will meet the pregnant women face to face
and fill out the Pregnant Identification Form, the Nonstress Test Follow-up Form and the
State Anxiety Scale.
Pregnant Identification Form: This form was developed by the researcher and consists of 20
questions, including 6 questions about the socio-demographic characteristics of pregnant
women, 11 questions about their obstetric characteristics, and 3 questions about vital signs.
Nonstress Test Follow-up Form: This form was developed by the researcher and consists of a
total of 16 questions, 7 questions that determine the thoughts of pregnant women about
Nonstress Test and 9 questions about the findings related to Nonstress Test.
State Anxiety Inventory: The State and Trait Anxiety Inventory was developed by Spielberger
et al. in 1970. The Turkish validity and reliability study of the scale was performed by Öner
and Le Compte in 1985. The State Anxiety Inventory is a 20-item scale used to determine how
an individual feels at a certain moment and under certain conditions. The scale can be
administered to individuals over the age of 14 individually or in groups and takes an average
of 10 minutes. The scores obtained from the scale theoretically vary between 20 and 80, with
a large score indicating a high level of anxiety and a low score indicating a low level of
anxiety.
Pre-Practice pre-study will be conducted with ten pregnant women before starting the study to
evaluate whether the questions have been understood. As a result of the evaluation, it will
be evaluated whether there is a need for editing in the data forms and adjustments will be
made. Those included in the preliminary study will not be included in the sample group.
Pregnant women who came for the Nonstress test, met the inclusion criteria and volunteered to
participate in the study will be informed about the study and an "Informed Consent Form" will
be obtained from those who volunteered to participate in the study. Before starting the
Nonstress test, the "Pregnant Identification Form" will be filled in by the researcher by
interviewing the pregnant woman face to face. Before the procedure, one fruit juice will be
drunk to prevent the difference between the eating times of the pregnant women. Then, the
vital signs of the pregnant women will be taken and the fundus height, situs and position
will be determined with the Leopold maneuvers by placing the pregnant women in the left
lateral recumbent position. According to Leopold maneuver findings, a tocotransducer will be
placed at the height of the fundus, and a transducer will be placed at the fetal ridge. Then,
a 20-minute NST recording will be started by giving a marker to the pregnant woman's hand.
One minute after the Nonstress test recording starts, the acupressure group will be applied
to the Zhi yin (BL67) acupuncture point with a depth of 0.1-0.2 cm, on the outer edge of the
little toes of both feet, at the nail end point. The application will be applied to both
points consecutively for 2 minutes at the same time and then a 3-minute rest period will be
repeated 2 times. Successive pressures will be applied at a frequency that has a calming
effect, so that the person is not disturbed or painful. After the nonstress test registration
is completed, the State Anxiety Scale will be filled in by the pregnant woman, and the
Nonstress Test Follow-up Form will be filled in by the researcher.
The halogen light group will be given halogen light stimulation for 10 seconds from the
mother's abdomen to the fetal head one minute after the start of the twenty-minute Nonstress
Test recording with a flashlight device (Vector VEC127Y 1 million candle power super sport
spotlight with stand) worth 1,000,000 candles. The procedure will be repeated on the same
spot 10 minutes after the first halogen light stimulation. After the nonstress test
registration is completed, the State Anxiety Scale will be filled in by the pregnant woman,
and the Nonstress Test Follow-up Form will be filled in by the researcher.
In the control group, no intervention will be made. The data of the study will be evaluated
using the SPSS 24 (PASW Inc., Chicago. IL. USA) program. All data will first be evaluated
with Kolmogorov-Smirnov for conformity to normal distribution and then analyzed according to
fitness for normal distribution. For descriptive statistics, percentages will be used in
general, arithmetic mean±standard deviation for those suitable for normal distribution,
median and minimum-maximum values for those that do not fit. Chi-square test, student t test,
ANOVA test for those with normal distribution, Mann-Whitney U and Kruskal Wallis tests for
those who are not suitable will be used in the analysis of data. Type 1 error level will be
taken as 0.05
