CompletedNot Applicable

The Effect of Stress Ball Application on Anxiety and Fetal Heart Rate Before Cesarean Section

Turkey (Türkiye)88 participantsStarted 2024-10-30

Plain-language summary

This study will be conducted to determine the effect of stress ball application on anxiety and fetal heart rate in risk pregnant women before cesarean section. Women with risk pregnancies randomly assigned to intervention (n=44) and control (n=44) groups in a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be instructed how to use the stress ball in the obstetrics ward before cesarean section. During the practice, pregnant women will be asked to demonstrate the movements of tightening and loosening the stress ball to ensure correct use. It will be emphasized to the pregnant women that they should squeeze the ball once after counting to three, inhale when they squeeze the ball, exhale when they loosen their grip and focus only on the ball. Pregnant women in the control group will not receive any intervention other than routine general care. Data will be collected face-to-face by the researcher based on the self-reports of the pregnant women before cesarean section.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Volunteering to participate in the research, * Be over 18 years of age, * Having a medically diagnosed risky condition during pregnancy (diabetes, hypertension, threat of preterm labor, pre-eclampsia, etc.), * Compliance with at least one of the criteria in the "Ministry of Health Risk Assessment Form for Pregnancy" in the evaluation of current pregnancy, * Planning a cesarean delivery, * Being in the last trimester of pregnancy (28 weeks and above) * Having a single live fetus, * To be able to read and write Turkish. Exclusion Criteria: * A diagnosed psychiatric illness, * Visual, hearing, speech, physical or mental disability, * Any communication barriers, * Cardiovascular disease in the pregnant woman and fetus, * Fetal distress, * Fetal anomaly, * Any physical or medical condition that prevents the use of a stress ball, * Need for urgent intervention before caesarean section according to the physician.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

State-Trait anxiety score for anxiety

Timeframe: Anxiety levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.

Fetal heart rate

Timeframe: Fetal heart rate levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.

Trial details

NCT IDNCT06646835

SponsorOndokuz Mayıs University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-30

View on ClinicalTrials.gov More Nursing trials