The Effect of Stress Ball Application on Anxiety and Fetal Heart Rate in Risk Pregnant Women Before Cesarean Section: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- State-Trait anxiety score for anxiety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
State-Trait anxiety score for anxiety
时间窗: Anxiety levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
The anxiety scale developed by Spielberger et al. in 1970 was designed to measure state and trait anxiety levels of individuals. The Turkish version of this scale was evaluated by Öner and Le Compte in 1983 and its reliability and validity were determined. The scale examines anxiety in two different dimensions: State Anxiety measures the feelings of an individual under a certain moment and condition, while Trait Anxiety refers to the general anxiety level of the individual. Each statement in the scale is a 4-point Likert scale (1-none, 2-somewhat, 3-a lot, 4-completely). Two types of expressions are used in the Spielberger State-Trait Anxiety Scale. Direct expressions indicate negative emotions and inverted expressions indicate positive emotions. Items 1,2,5,8,10,11,15,16,19 and 20 in the Spielberg State Anxiety Scale (SSAS) and items 26,27,30,33,36 and 39 in the Spielberg Trait Anxiety Scale (SSAS) are inverted statements. During the evaluation, after the total weights of the direct
Fetal heart rate
时间窗: Fetal heart rate levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
Fetal heart rate will be measured by fetal hand-held Doppler before and after the intervention.
次要结局
- Pulse rate (beats/minute)(Pulse rate of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.)
- respiration rate (times/minute)(Respiration rate of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.)
- systolic and diastolic blood pressure (mmHg)(Systolic and diastolic blood pressure of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.)
研究者
Nazlı Baltacı
Associate Professor, phD
Ondokuz Mayıs University