Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06391112 |
| Other study ID # |
OsmaniyeKAU-SBF-CA-01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
May 20, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Osmaniye Korkut Ata University |
| Contact |
cansu agrali, pHd |
| Phone |
0531746133 |
| Email |
agralicansu9[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
It is observed that art-based programs, one of the non-pharmacological methods, play an
active role in improving the health and well-being of pregnant women and reducing anxiety,
stress and depression. This shows that arts-based experiences offer women a unique
opportunity to explore all dimensions of the transition to motherhood. When the literature is
examined, it is seen that art-based interventions are used in birth units, neonatal intensive
care and high-risk pregnancy units. However, no study has been found in which it was applied
during the NST procedure. Therefore, the aim of our study is to examine the effect of
picture-based art intervention on the fetus during the Non-Stress Test on maternal anxiety
and fetal parameters.
Description:
Hypotheses:
H1: Painting-Based Art Intervention positively affects NST results. H2: Painting-Based Art
Intervention reduces the level of maternal anxiety.
Study protocol, methods and procedures to be applied:
Type of Research:
The research was planned as a randomized controlled clinical trial.
Place and Time of Research:
The research will be conducted at the NST polyclinic of Malatya Training and Research
Hospital between January 2024 and May 2024.
Population and Sample of the Research The population of the research will consist of pregnant
women who have applied to the NST polyclinic, have had at least one live birth, have had NST
before, do not have any psychiatric or risky pregnancy diagnoses, do not have communication
problems, and are older than the 32nd week of pregnancy.
There are 6 NST devices in the NST polyclinic where the research will be conducted. The
assignment of pregnant women to the experimental and control groups will be made according to
the device on which the NST procedure will be performed. It was decided by lottery method to
perform the procedures on pregnant women in the experimental or control group with the
devices numbered 1-6. In the draw held before the start of the research, it was determined
that the pregnant women who would be included in the Painting-Based Art Intervention group
with devices numbered 1, 4, 6, and the pregnant women who would be included in the control
group with devices numbered 2, 3, 5 would undergo NST procedure. In order to prevent
contamination between the experimental and control groups in the research, pregnant women who
first form the control and then the experimental groups will be included in the study.
Criteria for inclusion in the study:
Not having any risk factors during pregnancy (preeclampsia, eclampsia, intrauterine growth
retardation, PROM, gestational diabetes and hypertension, placenta previa, twin pregnancy,
etc.).
Lack of uterine contraction, No cardiovascular disease diagnosed in the fetus, Pregnant women
must be between the ages of 18-35 Conditions to be met before and during the NST procedure;
Not having smoked or consumed alcohol at least two hours before the NST procedure, Having
urinated before the NST procedure, Giving the pregnant woman the left side lateral position,
Blood pressure values measured just before the NST procedure should be within the normal
range,
Exclusion criteria for the study:
Any complications in the pregnancy, Any complications in the fetus, Refusal to accept the
final test to be performed. Data Collection Process Data Collection Tools Data will be
collected using the Introductory Information Form, State Anxiety Scale and Record Form for
NST Findings, developed by the researchers using the literature.
Participant Introduction Form The Participant Introduction Form consists of questions that
determine socio-demographic and obstetric characteristics, knowledge about NST findings, and
drawing-based intervention.
NST Findings Record Form NST Findings Registration Form is a form used by researchers to
evaluate NST results of pregnant women. This form contains data recording the findings of NST
of pregnant women.
Evaluation of NST Findings Record Form; All pregnant women who agree to participate in the
study will undergo NST with the NST device in the hospital. NST results of pregnant women
will be evaluated by researchers.
As reactive NST; In the presence of at least two accelerations that last for at least 15
seconds and are 15 beats/minute more than the baseline beat within the 20-minute period
during which the electronic fetal heart rate traces are printed, the result of the test will
be considered as reactive NST.
As nonreactive NST; The absence of at least two accelerations that last for at least 15
seconds and are 15 beats/minute more than the baseline beat within the 20-minute period
during which the electronic fetal heart rate traces are printed, in the presence of severe
variable decelerations and late decelerations, or continuous fetal tachycardia of 160
beats/minute and above when the initial traces are normal. If it develops, the result will be
evaluated as nonreactive NST.
State Anxiety Scale The state-trait anxiety scale, developed by Spielberg and his colleagues
in 1964 to measure the anxiety levels of normal and abnormal individuals, was adapted into
Turkish by Öner and Le Compte. The state anxiety part of the scale, which consists of two
parts, will be used. There are 20 statements in both scales, and the answer options include
four options, each ranging from 1 to 4.
The scales contain both direct (straight) expressions and reversed expressions. While direct
expressions express negative emotions, tInverted expressions reflect positive emotions. In
the State Anxiety Scale, these reversed statements are items 1, 2, 5, 8, 10, 11, 15, 16, 19,
and 20. The statements in the scale are answered by selecting the options (1) not at all, (2)
a little, (3) a lot and (4) completely in order to evaluate the emotions or behaviors
according to the severity of the experiences. The total score obtained varies between 20 and
80, a high score indicates a high level of anxiety.
