The Effect of Ice Massage Applied to SP6 Point on Labor Pain, Labor Comfort, Labor Duration, and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- severity of labor pain by VAS
研究概览
简要总结
Purpose: In the study , it was aimed to determine the effect of ice massage applied to SP6 point during labor on labor pain, labor comfort, labor duration, and anxiety.
Design: A single blind, randomized controlled experimental trial Setting and Participants: 100 primiparas, 50 in the intervention group and 50 in the control group, with 4-5 cm cervical dilatations were included in the study. Ice massage was applied to the SP6 point of the pregnant women in the intervention group at 4-5 cm, 6-7 cm, and 8-9 cm dilatations during three contractions.
Measurement Tools: The Pregnant Information Form, VAS, the Partograph Form, Childbirth Comfort Questionnaire (CCQ), and the State Anxiety Scale were used to collect data.
详细描述
The study was conducted as a randomized controlled trial in the Delivery Room of Ataturk City Hospital located in Balikesir province of Turkey between December 2021 and July 2022.
Participants The study sample size was calculated by using G*Power 3 power calculations based on previous studies in which ice massage was applied to acupressure points during labor. Impact estimation was obtained from the findings of the study conducted by Hajiamini et al., who reported pain severity as 5.90 ± 1.84 in the ice massage group and 7.10 ± 1.64 in the control group 30 minutes after the ice massage application. In the present study, it was aimed to determine a similar difference. The sample size for each group was determined to be at least 47 individuals. Accordingly, 50 primiparas were assigned to the intervention group and the control group each. The power analysis performed showed that the sample size of the study had a power as α = 0.05, Power = 0.91, df = 98. The decrease observed in labor pain at 4-5 cm cervical dilatation compared to the control group had an impact size of 0.61.
The inclusion criteria for the primiparas were having a single healthy fetus, having a gestational age between 38 and 40 weeks, expecting vaginal delivery, having fetal cephalic presentation, having no chronic diseases, not having a high-risk pregnancy, being in stage 1 of childbirth, and having a 4-5 cm cervical dilatation. Pregnant women who were multiparous, had multiple pregnancies, had high-risk pregnancy, had delivery with complications, and came to the clinic after 4-5 cm dilatation were excluded from the study.
Single blind block randomization for pregnant women who met the inclusion criteria was achieved by using Sequence Generator method located under the subheading of Numbers at random.org website. In the program, two columns were created according to the sample size. The pregnant women were randomly assigned to Column 1 or Column 2 according to their registration number. The assignment of the columns to either the intervention group or the control group was done through a draw. Ice massage was applied to SP6 points of the pregnant women in the intervention group, while the pregnant women in the control group was provided with standard midwifery care.
Data collection The Pregnant Information Form (PIF), Visual Analog Scale (VAS-1), and Childbirth Comfort Questionnaire (CCQ) were administered to the pregnant women who were at stage 1 of delivery and 4-5 cm cervical dilatation. Each group was provided with standard midwifery care, and intervention was made to the women in the intervention group at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilatation during three contractions. Immediately after the interventions, VAS-2, VAS-3, and VAS-4 were applied. In addition, following the intervention made at 6-7 cm cervical dilatation, The State Anxiety Scale (STAI-I) was applied between the contractions. After the interventions were completed, CCQ was applied again at 8-9 cm cervical dilatation. The pregnant women in the control group were administered VAS-2, VAS-3, and VAS-4 at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilatations, STAI-I at 6-7 cm cervical dilatation, and CCQ at 8-9 cm cervical dilatation.
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
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •expected vaginal delivery
- •single healthy fetus
- •primipara
- •in the first phase of the labor
排除标准
- •multipara
- •risky pregnancy
- •child with complications
- •multiple pregnancies
- •premature delivery
结局指标
主要结局
severity of labor pain by VAS
时间窗: immediately after the intervention
The scale was used in order to measure labor pain. It is made up of a vertical line ranging from 0 to 10 (Ferreira-Valente et al., 2011). In the study, VAS was applied before the intervention at 4-5 cm cervical dilatation (VAS-I) and after the intervention at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilatations (VAS-2, VAS-3, VAS-4, respectively).
次要结局
- duration of labor(during the procedure)
研究者
Hülya TÜRKMEN
associate professor
Balikesir University
