Effect of Stress Ball Intervention During the Active Phase of Labor on Pain, Comfort, and Childbirth Self-Efficacy: 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
- 78
- 试验地点
- 1
- 主要终点
- Pain Intensity During Active Labor
研究概览
简要总结
This randomized controlled trial evaluates the effects of a stress ball intervention during the active phase of labor on maternal pain, childbirth comfort, self-efficacy, and labor progress. Labor pain is a multidimensional experience influenced not only by physiological factors but also by psychological processes such as coping and perceived control. Simple non-pharmacological methods may support women's ability to manage contractions during labor.
Participants in the intervention group use a stress ball during uterine contractions throughout the active phase of labor, while the control group receives routine midwifery care. Pain intensity is measured at predefined cervical dilatation levels using a visual analog scale. Childbirth comfort and general self-efficacy are assessed before and after birth. Labor progress parameters, including contraction characteristics and fetal heart rate, are also monitored.
The study aims to determine whether stress ball use improves women's experience of labor without negatively affecting physiological labor progress.
详细描述
This study is a single-center, parallel-group randomized controlled trial designed to evaluate the effects of a stress ball intervention during the active phase of labor. The intervention is based on the theoretical framework of distraction and self-efficacy, aiming to support coping and perceived control during uterine contractions without interfering with the physiological course of labor.
Eligible participants are low-risk pregnant women in the active phase of spontaneous labor (cervical dilatation ≥5 cm). After baseline assessment, participants are randomized in a 1:1 ratio to either the intervention group or the control group. The intervention group receives routine midwifery care plus stress ball use during contractions throughout the active phase, while the control group receives routine care only.
Pain intensity is assessed at predefined cervical dilatation levels using a visual analog scale. Childbirth comfort and general self-efficacy are measured before and after birth. Labor progress parameters are monitored as part of routine clinical practice to evaluate safety and ensure that the intervention does not negatively affect physiological labor processes.
Data are analyzed using appropriate statistical methods for repeated measures to examine group differences over time and the interaction between group and cervical dilatation. The study aims to determine whether stress ball use influences maternal outcomes and labor progression in a safe and supportive manner.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancies between 37 and 42 weeks of gestation who were in the active phase of labor,
- •Had no mental or physical disabilities,
- •Could speak Turkish,
- •Volunteered to participate in the study.
排除标准
- •Pregnant women with high-risk pregnancies,
- •Systemic diseases, a history of medical or obstetric complications,
- •Those using epidural analgesia or pharmacological pain management
研究组 & 干预措施
Stress Ball + Routine Midwifery Care
Participants receive routine midwifery care plus stress ball use throughout the active phase of labor. Women are instructed to rhythmically squeeze the stress ball during uterine contractions and release it during relaxation phases. The intervention is integrated into contractions during active labor.
干预措施: Stress Ball (Device)
Routine Midwifery Care (Control)
Participants receive routine midwifery care only, including standard labor monitoring and supportive care according to hospital protocol.
结局指标
主要结局
Pain Intensity During Active Labor
时间窗: Measured at 5 cm, 6 cm, 8 cm, and 10 cm cervical dilatation during active labor.
Visual Analogue Scale (VAS) The VAS was used to assess perceived pain intensity. The scale consists of a 10 cm (100 mm) horizontal line, anchored by "no pain" (0 mm) at one end and "the worst pain imaginable" (100 mm) at the other. Participants were asked to indicate their level of pain by drawing a line, placing a mark, or indicating a point along the scale. The distance from the starting point to the marked point was measured in millimetres, and analyses were conducted on a 0-100 mm scale. On the VAS, scores between 0-44 mm indicate mild pain, 45-74 mm indicate moderate pain, and 75-100 mm indicate severe pain (Jensen, 2003). Assessments were performed hourly throughout the active phase of labour.
次要结局
- Childbirth Comfort Level(Baseline (active phase onset) and within 24 hours after birth.)
- Self-Efficacy Scale(Baseline (active phase onset) and within 24 hours after birth.)
研究者
Hediye Karakoç
Assoc.Prof.
KTO Karatay University