The Effect of Stress Ball Use During Non-Stress Test on Anxiety and Fetal Well-Being
in Women With High-Risk Pregnancy: A Randomized Controlled Study
Led by Hümeyra TÜLEK DENİZ · Updated on 2024-12-31
86
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
Official Title
Who Can Participate
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Trial Site Locations
Research Team
How is the study designed?
Frequently Asked Questions
Published Results
AI-Summary
What this Trial Is About
Researchers are investigating the effects of using a stress ball during the Non-Stress Test (NST) on anxiety and fetal well-being in women with high-risk pregnancies. High-risk pregnancies involve increased health risks for both mother and fetus due to conditions like diabetes, hypertension, or threats of premature birth. The study aims to understand if squeezing a stress ball during NST, a common fetal monitoring procedure, can reduce anxiety and improve outcomes compared to routine care without intervention.
Participants are divided into two groups: an intervention group who will be instructed to squeeze and release a soft stress ball in a specific breathing pattern during the approximately 20-minute NST, and a control group who will receive standard hospital care without the stress ball. The stress ball is a soft, handheld device about 6 cm in diameter, designed to relieve stress and muscle tension through squeezing. The practice involves coordinated breathing and focus on the ball throughout the NST.
Women taking part will have their anxiety levels measured 5 minutes before and 5 minutes after the NST procedure. Researchers will collect data on fetal well-being and anxiety to evaluate the stress ball's impact. Participants must attend the NST procedure and follow instructions during the test. Safety monitoring will be conducted, and the study includes assessments related to maternal anxiety and fetal health during the monitoring period.
CONDITIONS
Official Title
The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy
Who Can Participate
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
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 for current pregnancy
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
You will not qualify if you...
Deceleration or uterine contraction during NST
Presence of cardiovascular disease in the fetus
Presence of fetal distress
Presence of fetal anomaly
Needing urgent intervention according to the physician
Having a diagnosed psychiatric disease
Having a visual, hearing, speaking, physical, or mental disability
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
Ondokuz Mayıs University
Samsun, Turkey (Türkiye)
Actively Recruiting
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Research Team
H
Hümeyra TÜLEK DENİZ, MSc
N
Nedime Gül DOĞAN ÖZDEMİR, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Frequently Asked Questions
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The Effect of Stress Ball Use During Non-Stress Test on Anxiety and Fetal Well-Being
in Women With High-Risk Pregnancy: A Randomized Controlled Study | DecenTrialz