Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID06302010

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

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

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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