🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in Turkey / NCT06302010
Recruiting Not applicable

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

NCT06302010 · tracked via the Priya Life Science Turkey tracker
Sponsor
Hümeyra TÜLEK DENİZ
Phase
Not applicable
Started
2024-03-13
Last updated
2024-12-31

Condition(s) studied

AnxietyFetal ConditionsPregnancy Related

Investigational drug(s) / intervention(s)

Stress Ball Intervention

Stress 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.

Study 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
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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" in the evaluation of "Current Pregnancy" (Table 1) * 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. Exclusion Criteria: * Deceleration or uterine contraction during NST, * Presence of cardiovascular disease in the fetus, * Presence of fetal distress, * Presence of fetal anomaly, * According to the physician, urgent intervention is needed, * Having a diagnosed psychiatric disease, * Having a visual, hearing, speaking, physical or mental disability.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ondokuz Mayıs University Samsun Turkey (Türkiye) Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06302010 on ClinicalTrials.gov ↗ ← All trials in Turkey