Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06302010
Study type Interventional
Source Kafkas University
Contact Hümeyra TÜLEK DENIZ, MSc
Phone 0 474 242 68 40
Email humeyra.tulek@gmail.com
Status Not yet recruiting
Phase N/A
Start date March 1, 2024
Completion date August 31, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Recruiting NCT04961112 - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits N/A
Recruiting NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Completed NCT05980845 - The Effect Nature Sounds and Music on Hemodialysis Patients N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Completed NCT05585749 - Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients N/A
Terminated NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Recruiting NCT05997849 - Development of a Multiplatform Mental Health Mobile Tool N/A
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care