Using stress balls to reduce anxiety during non-stress tests in high-risk pregnancies
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
NA · Kafkas University · NCT06302010
This study is testing if using stress balls can help reduce anxiety and improve fetal well-being during non-stress tests for women with high-risk pregnancies.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Kafkas University (other) |
| Locations | 1 site (Samsun) |
| Trial ID | NCT06302010 on ClinicalTrials.gov |
What this trial studies
This research investigates the impact of a stress ball intervention on anxiety levels and fetal well-being during non-stress tests (NST) in high-risk pregnant women. Participants will be randomly assigned to either an intervention group, where they will use a stress ball during the NST, or a control group receiving standard care. The intervention involves a specific breathing and squeezing technique aimed at promoting relaxation. Data on anxiety and fetal outcomes will be collected before and after the NST to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old with medically diagnosed high-risk pregnancies, at or beyond 32 weeks gestation, and able to read and write Turkish.
Not a fit: Patients experiencing fetal distress, anomalies, or requiring urgent medical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help reduce anxiety in high-risk pregnant women, potentially improving fetal well-being.
How similar studies have performed: While similar interventions have been explored, this specific approach using stress balls during NSTs in high-risk pregnancies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Samsun
- Ondokuz Mayıs University — Samsun, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Hümeyra TÜLEK DENİZ, MSc
- Email: humeyra.tulek@gmail.com
- Phone: 0 474 242 68 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anxiety, Fetal Conditions, Pregnancy Related, anxiety, fetal well-being, high-risk pregnant women, Non stres test, stress ball