RecruitingNot ApplicableNCT06302010

The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy

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

Sponsor

Hümeyra TÜLEK DENİZ

Enrollment

86 participants

Start Date

Mar 13, 2024

Study Type

INTERVENTIONAL

Conditions

Anxiety Pregnancy Related Fetal Conditions

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether squeezing a stress ball during a non-stress test (NST) — a routine monitoring test done in high-risk pregnancies to check on the baby — can help reduce anxiety in pregnant women and improve the baby's test results. The NST involves monitoring the baby's heart rate while the mother rests. **You may be eligible if...** - You are over 18 years old - You have a high-risk pregnancy (e.g., diabetes, high blood pressure, risk of preterm birth, or pre-eclampsia) - You are at 32 weeks or more of pregnancy - You are carrying a single baby - You can read and write Turkish - You have eaten at least 2 hours before the test and have not smoked or consumed alcohol in the past 2 hours **You may NOT be eligible if...** - You experience contractions or decelerations in the baby's heart rate during the test - Your baby has a known heart condition - You have serious complications during the test Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALStress Ball Intervention

The stress ball has a soft plastic or silicone structure that can be held comfortably. Each ball is approximately 6 cm in diameter, in different colors, and is a soft toy that can be squeezed and manipulated with fingers to relieve stress and muscle tension and exercise the muscles (Apaydin Cirik et al., 2023). Squeezing a stress ball is a distraction and relaxation method. It is thought that squeezing a stress ball may be advantageous for reducing anxiety, considering its reliability, easy accessibility, effectiveness, low cost, sustainability, non-pharmacological and non-invasive properties.