The Effect of White Noise and Stress Balls Applied During NST to Pregnant Women Scheduled for Cesarean Section on Anxiety, Fetal Well-being, and Fear of Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 7
- 主要终点
- Surgical Fear Questionnaire (SFQ)
研究概览
简要总结
This study aims to determine the effect of white noise and stress balls administered during NST on anxiety, fetal well-being, and fear of surgery in pregnant women scheduled for planned cesarean sections. A total of 168 pregnant women will be included in the study, divided into 4 groups (white noise group, stress ball group, white noise group + stress ball group, and control group).
详细描述
Participants will only be exposed to white noise and stress ball therapy; no invasive procedures will be performed.
Experimental Group Participants will be invited to participate in the study through face-to-face interviews conducted individually. Participants assigned to the experimental group via randomization will be informed about the study and their consent will be obtained.
Pregnant women who agree to participate in the study will receive the intervention starting 15 minutes before the NST application and continuing throughout the NST application; those in the white noise group will listen to white noise, those in the stress ball group will receive the stress ball intervention, and those in the white noise + stress ball group will listen to white noise and receive the stress ball intervention. Before the session begins, the "Informative Information Form," "NST Findings Record Form," "Surgical Fear Scale," and "Spielberger State Anxiety Inventory" will be administered. After the NST application, the "NST Findings Record Form," "Spielberger State Anxiety Inventory," and "Surgical Fear Scale" will be administered.
Control Group Participants will be invited to participate in the study through face-to-face interviews conducted individually. Participants in the control group will be informed about the study and their consent will be obtained according to the randomization method. No intervention other than routine care will be performed. Participants in the control group will first be administered the "Informative Information Form," "NST Findings Record Form," "Surgical Fear Scale," and "Spielberger State Anxiety Inventory" for the pre-test. After the NST application is completed, the "NST Findings Record Form," "Spielberger State Anxiety Inventory," and "Surgical Fear Scale" will be administered.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •No communication barriers
- •32-38 weeks of gestation,
- •Planning a cesarean delivery,
- •No risk factors during pregnancy (preeclampsia, IUGR, premature rupture of membranes, gestational diabetes, etc.),
- •Single pregnancy,
- •No health problems (such as fetal anomaly, intrauterine growth restriction) in the fetus
排除标准
- •Having any risk factors during pregnancy (preeclampsia, IUGR, premature rupture of membranes, gestational diabetes, etc.)
- •Having a multiple pregnancy
- •Having a fetus with any health problems (such as fetal anomaly, intrauterine growth restriction) Exclusion criteria from the study
- •Incomplete responses to the survey questions
- •Wish to withdraw from the study,
- •Development of a risk condition during pregnancy,
研究组 & 干预措施
Group 3
white noise + stress ball group
干预措施: White noise + stress ball (Other)
Group 4
standard care group
Group 1
only white noise group
干预措施: only white noise (Other)
Group 2
Only stress ball
干预措施: only stress ball (Other)
结局指标
主要结局
Surgical Fear Questionnaire (SFQ)
时间窗: preoperative
to determine the level of fear caused by the short- and long-term outcomes of surgical operations in patients undergoing elective surgery
Spielberger State Anxiety Inventory
时间窗: preoperative
to measure state anxiety levels in normal and abnormal individuals. It is a self-assessment type measure consisting of short statements. The State Anxiety Inventory was developed to measure a person's anxiety at a specific moment. The 20-item State Anxiety Inventory is a measure that determines how an individual feels at a specific moment and under specific conditions. The feelings or behaviors expressed in the items of the State Anxiety Inventory are answered by selecting one of the options (1) not at all, (2) a little, (3) very much, (4) completely) according to the degree of intensity. There are 10 reverse-scored items in the inventory. These items are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The state anxiety score is calculated by adding 50 points to the difference between the total weighted scores of the direct and reverse items.
NST Finding Form The Non-Stress Test (NST)
时间窗: preoperative
It is an assessment method that measures the response of fetal heart rate to fetal movements over time. If at least two or more fetal movements are observed during a 20-minute monitoring period and an increase in heart rate of at least 15 beats (acceleration) lasting at least 15 seconds occurs during these movements, the result is considered reactive or "reassuring" (ACOG, 2019). Furthermore, the absence of decelerations on the NST and an average fetal heart rate between 110-160 bpm are indicators of a healthy fetal condition (Güngör, 2016; Nacar \& Türkmen, 2022; Umana, 2022). In this context, the NST finding form was prepared by researchers, guided by the literature, to include the mean fetal heart rate, acceleration and deceleration status, and reactive/non-reactive status.
Surgical Fear Questionnaire (SFQ)
时间窗: preoperative
to determine the level of fear caused by the short- and long-term outcomes of surgical operations in patients undergoing elective surgery
Spielberger State Anxiety Inventory
时间窗: preoperative
to measure state anxiety levels in normal and abnormal individuals. It is a self-assessment type measure consisting of short statements. The State Anxiety Inventory was developed to measure a person's anxiety at a specific moment. The 20-item State Anxiety Inventory is a measure that determines how an individual feels at a specific moment and under specific conditions. The feelings or behaviors expressed in the items of the State Anxiety Inventory are answered by selecting one of the options (1) not at all, (2) a little, (3) very much, (4) completely) according to the degree of intensity. There are 10 reverse-scored items in the inventory. These items are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The state anxiety score is calculated by adding 50 points to the difference between the total weighted scores of the direct and reverse items.
Personal Information Form (PIF)
时间窗: preoperative
This form was developed by researchers to identify some of the individual characteristics of pregnant women. It includes questions about some of the women's sociodemographic characteristics (such as age, education level, income and employment status, surgical history, and history of cesarean section).
NST Finding Form The Non-Stress Test (NST)
时间窗: preoperative
It is an assessment method that measures the response of fetal heart rate to fetal movements over time. If at least two or more fetal movements are observed during a 20-minute monitoring period and an increase in heart rate of at least 15 beats (acceleration) lasting at least 15 seconds occurs during these movements, the result is considered reactive or "reassuring" (ACOG, 2019). Furthermore, the absence of decelerations on the NST and an average fetal heart rate between 110-160 bpm are indicators of a healthy fetal condition (Güngör, 2016; Nacar \& Türkmen, 2022; Umana, 2022). In this context, the NST finding form was prepared by researchers, guided by the literature, to include the mean fetal heart rate, acceleration and deceleration status, and reactive/non-reactive status.
次要结局
未报告次要终点
研究者
NURTEN ÖZÇALKAP
Asistant Professor
Agri Ibrahim Cecen University