Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302010
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-10
Brief Title:
The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy
Sponsor:
Hümeyra TÜLEK DENİZ
Organization:
Kafkas University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n43 and control n43 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 443 to 352 in 25 years According to the results of the 2014 Turkey Demographic and Health Surveys the risky pregnancy rate which was 311 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 womans 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
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 womans 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None