Clinical trial NCT06302010: The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy
Official title: The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in Women With High-risk Pregnancy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Fetal Conditions
Pregnancy Related
Keywords: anxiety
fetal well-being
high-risk pregnant women
Non stres test
stress ball
nurse
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research will be conducted as a two-group, parallel, randomized, controlled experimental study with a pretest-posttest design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research will be conducted to determine the effect of stress ball intervention during NST on anxiety and fetal well-being in high-risk pregnant women. Women with high-risk pregnancies randomly assigned to intervention (n=43) and control (n=43) groups at a state and a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be told to squeeze and release the ball once after counting to three, to inhale each time they press the ball, to exhale when they relax their grip and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure. Data on anxiety and fetal well-being outcomes will be collected before and after NST.

Detailed description: Risky pregnancy refers to a situation in which there is a higher probability of negatively affecting the health and life of the pregnant woman and the fetus due to problems such as premature birth, premature rupture of membranes, cervical insufficiency, and placenta previa compared to normal pregnancies. Demographic and Health Research considers risky pregnancies as teenage pregnancies under the age of 18, pregnancies over the age of 35, births less than two years apart, and pregnancies with a parity of more than three births. Worldwide, 20 million women have high-risk pregnancies, and more than 800 women die from perinatal causes every day. 6-33% of these losses are in the high-risk pregnancy group. Worldwide, 5-10% of all pregnancies are complicated by preeclampsia. Malaria, tuberculosis, and chronic iron deficiency anemia are among the other most common pregnancy complications. In our country, the number of risky pregnancies has gradually decreased, but one in every three pregnant women is still a problematic pregnancy. Turkey Demographic and Health Surveys (TDHS) findings show that the risky pregnancy rate decreased from 44.3% to 35.2% in 25 years. According to the results of the 2014 Turkey Demographic and Health Surveys, the risky pregnancy rate, which was 31.1%, increased again in 2018.

In women who are diagnosed with complex and high-risk pregnancies that pose additional risks during pregnancy and have obstetric complications, the incidence of serious psychological problems, especially depression, is higher during pregnancy. The risk of anomaly diagnosed in the newborn causes maternal psychological issues throughout pregnancy. It has been shown that maternal psychosocial stress experienced during the antenatal period increases maternal infections, causes hormonal changes, and plays a role in the etiopathogenesis of fetal neurodevelopmental disorders, with long-term consequences such as poor birth outcomes including preterm birth and low birth weight, insulin resistance, and cardiovascular disease. High-risk pregnancies may require lifestyle changes, medical support, and even hospitalization. Depending on the severity of the pregnant woman's health condition, hospitalization may be necessary for high-risk pregnancies, starting weeks or months before the birth of the baby, and frequent NST monitoring may be required during this monitoring period. Risky pregnant women who are hospitalized during the antepartum period may experience psychological problems such as shock, depression, anxiety, sleep disorders, boredom, fear for the fetus and their health, guilt, feeling trapped, loss of control, weakness, loneliness, anger, and anxiety. The negative emotional state of a high-risk pregnant woman negatively affects the continuation of the pregnancy and may cause maternal-fetal attachment to be involved.

When biopsychosocial changes occur during pregnancy, maternal and fetal well-being must be maintained at the highest level. Nowadays, the Nonstress Test (NST) is widely used to evaluate fetal well-being in the intrauterine period because it is invasive and easy to interpret. NST is a non-invasive method with minimal risk for the mother and fetus, which is used to evaluate the fetal health status and maternal contractions in the prenatal period starting from the 32nd week of gestation and records the fetal heart rate with an electronic monitor. NST is based on the evaluation of fetal oxygenation. Although it is a painless procedure, it takes approximately 20 minutes, and the pregnant woman remains in the same position throughout the procedure, which creates stress and anxiety in the pregnant woman. High anxiety of the pregnant woman during the procedure affects the test result and may cause incorrect evaluation by increasing the false positivity rate. This increase in the false positivity rate in NST results may increase the practice of operative delivery.

It is the responsibility of nurses to eliminate situations that cause anxiety in pregnant women before and during the NST procedure and may affect the NST result. Stress ball, one of the non-pharmacological cognitive distraction methods, is easily accessible, low-cost, and reliable. When looking at the literature, the effects of the stress ball on psychometric parameters and vital signs such as anxiety, stress, depression, anxiety, comfort, and satisfaction in procedures such as colonoscopy, endoscopy, ESWL, prostate biopsy, radiography, hemodialysis, IV catheterization, PCR taking were examined. However, the effect of a stress ball on anxiety or the fetus during NST in high-risk pregnancies has not been investigated.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the research,
* Being over 18 years of age,
* Having a medically diagnosed risky condition during pregnancy (diabetes, hypertension, the threat of premature birth, eclampsia, etc.)
* Compliance with at least one of the criteria in the "Ministry of Health Pregnancy Risk Assessment Form" in the evaluation of "Current Pregnancy" (Table 1)
* Being at or above the 32nd week of pregnancy,
* Having a single living fetus,
* Having eaten at least two hours before the NST procedure,
* Not having smoked or consumed alcohol at least two hours before the NST procedure,
* Knowing how to read and write Turkish.

Exclusion Criteria:

* Deceleration or uterine contraction during NST,
* Presence of cardiovascular disease in the fetus,
* Presence of fetal distress,
* Presence of fetal anomaly,
* According to the physician, urgent intervention is needed,
* Having a diagnosed psychiatric disease,
* Having a visual, hearing, speaking, physical or mental disability.

Primary outcomes:
measure: Anxiety
timeFrame: 5 minutes before intervention and 5 minutes after the end of the intervention.
Secondary outcomes:
measure: Fetal well-being
timeFrame: 5 minutes before the intervention and 5 minutes after the end of the intervention.
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
affiliation: Ondokuz Mayıs University
name: Nazlı BALTACI, RN, PhD
role: STUDY_DIRECTOR
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