The Effect of Sacral Region-focused Therapeutic Touch Applied During the Latent Phase of Labour on Hormone Levels, Labour Comfort and Perception: A Randomized Sham Controlled Trialt
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
This study was conducted to determine the effect of sacral region-focused therapeutic touch applied during the latent phase of labour on hormone levels, labour comfort, and perception.
A randomized sham controlled trial design was used in the study, which was conducted with 50 primiparous pregnant women. While Therapeutic Touch (25) focused on sacral region was applied in the intervention group, Sham Therapeutic Touch (25) was applied in the control group. Data were collected using a Personal Information Form, the Visual Analogue Scale, a Hormone Values Follow-up Form, the Childbirth Comfort Questionnaire and the Perception of Birth Scale.
Keywords: Labor Pain,Therapeutic Touch, Childbirth, Hormones
详细描述
Aim: This study was conducted to determine the effect of sacral region-focused therapeutic touch applied during the latent phase of labour on hormone levels, labour comfort, and perception.
Method: This randomised sham controlled experimental trial was conducted with two groups (intervention and control groups) in a state hospital between 08 March 2022 and 01 April 2023. The sample size of the study was calculated using the G*power 3.1.9.6 programme. As a result of the calculation, twenty-five pregnant women for each group were included in the study. While Therapeutic Touch (TT) focused on sacral region was applied in the intervention group, Sham Therapeutic Touch (STT) was applied in the control group. Data were collected using a Personal Information Form, the Visual Analogue Scale (VAS), a Hormone Values Follow-up Form, the Childbirth Comfort Questionnaire (CCQ) and the Perception of Birth Scale (PBS). IBM SPSS V25 programme was used for statistical analysis of the study. The statistical significance was assessed at the level of p<0.05.
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
- Double (Participant, Outcomes Assessor)
盲法说明
In addition to ensuring the blinding of the participants in the study, blinding was also performed during the data collection, hormone values analysis, statistics and reporting stages. Women who agreed to participate in the study were not informed about the group they were assigned to. Since the participants did not know to which group they were assigned, the study was conducted in a single-blind design.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being primipara,
- •Having a gestational age of 38-42 weeks,
- •Planning to have a normal vaginal delivery,
- •Having a 3-4 cm dilation in the latent phase,
- •Having a single fetus and head presentation,
- •Speaking and communicating in Turkish,
- •Agreeing to participate in the study,
- •Having no high-risk pregnancy.
排除标准
- •Receiving induction,
- •Receiving labor analgesia/anesthesia,
- •Having sensitivity or problems with touch,
- •Having to leave during the intervention due to some reasons such as medical procedures, etc.
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: VAS were evaluated after application 30 minutes in each groups.
VAS is a one-dimensional scale that objectively assesses pregnant woman's perception of pain. VAS is a 100 mm scale (10-cm) that represents lack of pain (0=no pain) on one end and worst possible pain (10=severe pain) on the other end; the scale is used to determine the severity of pain quantitatively. The patient marks any point between the two ends that describe his/her pain severity. The point between lack of pain and the point indicated by the patient is measured using a ruler and recorded as cm. These numeric values indicate the pregnant woman's pain severity.
次要结局
- The Perception of Birth Scale (PBS)(PBS were evaluated after delivery in each groups.)
研究者
Ebru Gözüyeşil
Associate Prof.
Cukurova University