The Effect of Music During Non-Stress Testing on Women's Comfort, Vital Signs and Anxiety: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- During Non-Stress Testing on Women's Comfort Level
研究概览
简要总结
Music has direct and indirect positive effects on the mother and fetus during pregnancy and perinatal period. This study was aimed at investigating effects of music played during the Non-Stress Test (NST) procedure on the mother's comfort, vital signs and anxiety.
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)
盲法说明
The participating pregnant women were not informed of the group they belonged to. Since only the researcher knew the participants' groups, single-blindness was achieved in the study.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-45 years
- •Completion of at least the 32nd week of gestation
- •No pregnancy-related risk factors (e.g., premature rupture of membranes, preeclampsia, gestational diabetes)
- •No multiple pregnancy
- •Normal blood pressure levels (not ≤80/60 mmHg and not ≥140/90 mmHg)
- •Having eaten at least two hours before the NST procedure
- •No smoking or alcohol consumption for at least two hours before the NST procedure
- •Ability to communicate effectively
- •No hearing impairment
- •Voluntary participation in the study
排除标准
- •Pregnant women with fetal distress
- •Cases for whom the physician considered emergency intervention necessary
- •Individuals with an impaired NST requiring immediate intervention
- •Individuals with a diagnosed psychiatric disorder
- •Individuals with hearing impairment
结局指标
主要结局
During Non-Stress Testing on Women's Comfort Level
时间窗: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
Prenatal Comfort Scale (PCS) was used to determine women's comfort level. The short version of the PCS consists of 15 items. Response given to the items are rated on a six-point Likert type scale ranging from 0 to 5 (0 = Strongly disagree, 1 = Disagree, 2 = Undecided, 3 = Somewhat agree, 4 = Agree, 5 = Strongly agree). The minimum and maximum possible scores that can be obtained from the PCS are 0 and 75, respectively. The higher the score is the higher the comfort level is.
During Non-Stress Testing on Women's Systolic Blood Pressure Level
时间窗: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
The women's systolic blood pressure levels were measured with a calibrated electronic sphygmomanometer. Blood pressure levels are expressed in millimeters of mercury (mmHg).
During Non-Stress Testing on Women's Diastolic Blood Pressure Level
时间窗: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
The women's diastolic blood pressure levels were measured with a calibrated electronic sphygmomanometer. Blood pressure levels are expressed in millimeters of mercury (mmHg).
During Non-Stress Testing on Women's Diastolic Heart Rate Level
时间窗: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
Heart rate level was determined electronically. Heart rate level was recorded in beats per minute (bpm).
During Non-Stress Testing on Women's Anxiety Level
时间窗: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
State Anxiety Scale (SAS) was used to determine the anxiety level. The scale is a 4-point Likert type, "not at all" (1), "somewhat" (2), "moderately" (3), "very much" (4). The scale consists of 20 items and items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reverse scored. To calculate the total score of the SAS, the total score of the reversed items is subtracted from the total score of the non-reversed items. Then, 50 points, which is the constant value of the state anxiety scale, are added to this score. The result is the score for the overall SAS. The total score varies between 20 and 80. The higher the score is the higher the level of the anxiety is. While a score ranging between 0 and 19 indicates "no anxiety", a score ranging between 20 and 39 indicates mild anxiety, a score ranging between 40 and 59 indicates moderate anxiety, a score ranging between 60 and 79 indicates severe anxiety, and a score of 80 indicates very severe anxiety (Panic).
次要结局
未报告次要终点
研究者
GAMZE GOKE ARSLAN
Asistant Professor, Department of Nursing
Karamanoğlu Mehmetbey University