The Effect of Progressive Muscle Relaxation Exercise Applied Before Endometrial Biopsy on Pain, Anxiety Level and Patient Comfort in Premenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
This study was designed to determine the effect of progressive muscle relaxation exercises performed before endometrial biopsy on pain, anxiety levels, and patient comfort in premenopausal women.
详细描述
This study aims to implement progressive muscle relaxation exercises to control and minimize feelings such as pain, anxiety, and discomfort experienced by women prior to undergoing endometrial biopsy procedures for diagnostic and screening purposes during the premenopausal period. The study aims to examine whether the application of progressive muscle relaxation exercises results in a reduction in pre-procedure anxiety and an increase in comfort among women.
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Endometrial biopsy request must be performed using an endometrial biopsy cannula (Pipelle).
- •Aged 40 years or older with irregular cycles.
- •At least a primary school graduate.
- •No impediment to performing progressive relaxation exercises.
- •The patient's consent to participate in the study.
排除标准
- •Presence of any physical or mental disability.
- •The patient's refusal to participate in the study.
- •Presence of any neurological or psychiatric disorder/use of medication
- •Having entered menopause.
- •Having a disease that could prevent the exercises from being performed (musculoskeletal problems, asthma, etc.).
- •The patient having previously undergone an abortion, endometrial biopsy, or endocervical biopsy.
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 2 months
Pain intensity was assessed using the Visual Analog Scale (VAS), a simple, reliable, and widely used unidimensional measure of subjective pain intensity (Hawker et al., 2011). The scale consists of a 10-cm horizontal or vertical line anchored by two descriptors representing the extremes of pain (0 = "no pain" and 10 = "worst imaginable pain"). Participants were asked to mark on the line the point that best represented their pain intensity. The score was determined by measuring the distance (in millimeters) from the "no pain" anchor to the participant's mark. It has been shown to correlate well with other clinical pain assessment tools and is frequently used in both research and clinical settings for its ease of use and sensitivity(Jensen et al., 1986).
State Anxiety Inventory (STAI Form I)
时间窗: 2 months
State anxiety was assessed using the State-Trait Anxiety Inventory (STAI Form I), originally developed by Spielberger and colleagues to measure situational anxiety levels. The scale consists of 20 items evaluating how individuals feel "at the moment," rated on a 4-point Likert scale (1 = not at all to 4 = very much so). The Turkish validity and reliability study was conducted by Öner and Le Compte. The scale includes both direct and reverse-scored items (10 reverse items: 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20). Total scores range from 20 to 80, with higher scores indicating greater anxiety levels. In the present study, the internal consistency of the STAI was high (Cronbach's α = 0.888).
General Comfort Questionaire (GCQ)
时间窗: 2 months
Comfort was assessed using the General Comfort Questionnaire (GCQ), developed by Kolcaba based on the taxonomic structure of comfort theory, which includes three levels and four dimensions. The 48-item instrument is rated on a 4-point Likert scale and includes both positively and negatively worded items; negative items are reverse scored. Total scores range from 48 to 192, with higher scores indicating greater comfort. The final score is calculated by dividing the total score by the number of items, yielding a mean score between 1 and 4. The Turkish validity and reliability study was conducted by Karabacak and Kuğuoğlu, reporting a Cronbach's α of 0.85. In the present study, the internal consistency of the GCQ was excellent (Cronbach's α = 0.926). Subscale reliability coefficients were 0.915 for Relief, 0.908 for Ease, and 0.899 for Transcendence, indicating high reliability.
次要结局
未报告次要终点
研究者
Ayşegül KARAKOÇ
Principal Investigator
Uskudar University