The Effects of the One Hour-Whole Body Prenatal Massage Therapy Session on Prenatal Distress and Prenatal Attachment for Women and Their Fetuses During Late Pregnancy: A Randomized Controlled Experimental Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Prenatal Attachment Inventory (PAI):
研究概览
简要总结
Background: Massage therapy in many parts of the world is used in all periods of pregnancy.
Aim: The study aimed to determine the effect of massage therapy during pregnancy on women and their fetuses in a university hospital in Izmir, Turkey.
Method: A randomized controlled experimental trial was aimed to reach primipara pregnant women, 20-35 years old, who came to a university obstetric clinic to get the results of the first-trimester screen test. Researchers aimed to reach 30 pregnant women at the start of the study. Participants were randomly allocated to a parallel comparison group by a central office. The sampling technique has been applied according to the CONSORT criteria.
The study practices have been carried out after receiving ethics committee and institution approvals after the researcher completed the prenatal massage therapy training, and after taking the voluntary informed consent of the pregnant women. The practices have been carried out in the massage office that was formed within the scope of the study. Electronic fetal monitoring (EFM), BPP, vital signs, fetal heart rate (FHR) evaluation have been carried out for the pregnants whose routine gestational monitoring went on during their gestational week between the 30th and 34th in the control group, and Pregnant Description Form, VAS, Prenatal Attachment Inventory-PAI, Revised Prenatal Distress Questionnaire-PDQ have been applied. In the prenatal massage therapy group, between the 30th and 34th weeks, each week for five weeks, prenatal massage therapy including a 60 minutes deep tissue and Sweden massage methods had been applied once a week. Side-Lying Positioning System that is designed specifically for the pregnant has been used during the practices. In addition, the reason why the study group consisted of pregnant women in these weeks; Perinatology specialists recommend women to experience a deep and sustainable level of relaxation for 45-60 minutes before falling asleep, especially in the last 6-8 weeks of pregnancy, in preparation for labour (Osborne et al. 2021). In line with this suggestion, since the whole body massage has been performed in the research method, a 60-minute massage (30 minutes for each lateral position) has been applied.
详细描述
Aim: The study aims to determine the effect of massage during pregnancy on women and their fetuses in a university hospital in Izmir, Turkey.
Method: The study was a randomized controlled experimental trial carried out with 20-35 years-old primipara pregnant women who came to obstetrics polyclinic of a university for evaluation of their first-trimester screen test's results, had no infertility story and were not at high risk (inclusion criteria). The participants were randomly allocated to the parallel comparison groups by a central office. The sample selection process in the study has been planned to be applied according to the CONSORT criteria (Moher et al. 2010) and the permutation method with blocked randomization has been done to the records assigned from the centre that the study was applied (Kanık, Tasdelen, and Erdogan 2011). In the process of collecting data, one blinding method has been applied, and it has only been applied to data analysis. Researchers aimed to reach 30 pregnant women at the start of the study. The completion decision of the data gathering process has been determined with power analysis that is carried out by the PASS program.
The study practices have been carried out after receiving ethics committee and institution approvals after the researcher completed the prenatal massage therapy training, and after taking the voluntary informed consent of the pregnant women. The practices have been carried out in the massage office that was formed within the scope of the study. Electronic fetal monitoring (EFM), BPP, vital signs, fetal heart rate (FHR) evaluation have been carried out for the pregnants whose routine gestational monitoring went on during their gestational week between the 30th and 34th in the control group, and Pregnant Description Form, VAS, Prenatal Attachment Inventory-PAI, Revised Prenatal Distress Questionnaire-PDQ have been applied. In the prenatal massage therapy group, between the 30th and 34th weeks, each week for five weeks, prenatal massage therapy including a 60 minutes deep tissue and Sweden massage methods had been applied once a week. Side-Lying Positioning System that is designed specifically for the pregnant has been used during the practices. In addition, the reason why the study group consisted of pregnant women in these weeks; Perinatology specialists recommend women to experience a deep and sustainable level of relaxation for 45-60 minutes before falling asleep, especially in the last 6-8 weeks of pregnancy, in preparation for labour (Osborne et al. 2021). In line with this suggestion, since the whole body massage has been performed in the research method, a 60-minute massage (30 minutes for each lateral position) has been applied.
Like before the prenatal massage therapy on the first date and after the prenatal massage therapy on the last date in the control group, all the forms and measurements have been applied. Pregnant women's VAS was measured before and after the prenatal massage therapy and the evaluation of the other measured data have been held between the 31st and 33rd gestational weeks. Also, Visual Analog Patient Satisfaction Scale-VAPSS has been measured after each prenatal massage therapy for finding satisfaction levels. In the process of the study, any significant side effect related to the practices hasn't occurred. The completion decision of the data gathering process has been determined with power analysis that was carried out by PASS program. The analysis of the study data has been carried out through SPSS 16 program.
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)
盲法说明
The pregnant women in control and prenatal massage therapy groups were appointed to different times to avoid each other. At the beginning of the study, they didn't know in which group they were taken to participate in the study. In the process of gathering data, the single-blind method has been applied, and the double-blind method has only been applied to data analysis (The double-blind method was not used in the data collection process in order to reveal the loss of the study conducted within the scope of the doctoral thesis and the fact that prenatal massage therapy practice is not performed routinely in country conditions). However, single blinding was performed in terms of the outcomes. The data obtained from the research were analyzed by Biostatistics and Medical Information Department at Ege University.
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •20-35 years-old
- •Primiparous women
- •Low-risk pregnant women
- •Before the 30th week of gestation Also for the group of the prenatal massage therapy;
- •Can come 5 times for each week of gestation between 30 and 34 weeks
- •No infectious disease or skin infection on the skin,
- •No thrombosis or phlebitis
- •Single and healthy fetus
- •Written and verbally available
- •Before the 30th week of gestation
- •Accept attendance
- •Residing in the province in which the study conducted city
排除标准
- •Infertility story
- •High risk pregnancy
- •Live or stillbirth after 20th week of gestation
- •Abortion after the first trimester
- •History of recurrent pregnancy loss
结局指标
主要结局
Prenatal Attachment Inventory (PAI):
时间窗: from 30 weeks up to 34 weeks
The scale was developed by Muller (1993) and its Turkish validity-reliability study was carried out by Dereli Yılmaz and Kızılkaya Beji (2013). It is used to explain women's thoughts, feelings and situations during pregnancy and to determine the level of attachment to the baby in the prenatal period. Increased score from the scale shows that the prenatal attachment level increases. Cronbach alpha reliability coefficients ranged from 0.81 (Muller 1993) and 0.84 (Dereli Yilmaz and Kızılkaya Beji 2013). The internal reliability of this instrument was 0.87 for 30th week and 0.90 for 34th week in this sample.
Revised Prenatal Distress Questionnaire (NuPDQ):
时间窗: from 30 weeks up to 34 weeks
The scale with different versions was developed by Yali and Lobel and the version of 17-item NuPDQ was revised by Lobel et al. (Lobel 2008; Yali and Lobel 1999). Its Turkish validity-reliability study was carried out by Yüksel et all. (Yüksel, Akın, and Durna 2011). It evaluates difficulties in pregnancy which about specific concerns and anxieties specific to the pregnancy period, such as medical problems, physical symptoms, parenting, relationships, bodily changes, birth and baby's health. The reduction of the total score of the scale shows that the prenatal distress level perceived by pregnant women decreases. Cronbach alpha reliability coefficients ranged from 0.79-0.88 (Ibrahim and Lobel 2020) and 0.85 (Yüksel et al. 2011). The internal reliability of this instrument was 0.73 for 30th week and 0.85 for 34th week in this sample.
次要结局
- Fetal hearth rate (FHR):(from 30 weeks up to 34 weeks)
- Visual Analog Scale (VAS):(from 30 weeks up to 34 weeks)
- Visual Analog Patient Satisfaction Scale-VAPSS:(from 30 weeks up to 34 weeks)
- Maternal hearth rate (MHR):(from 30 weeks up to 34 weeks)
- Biophysical Profile (BPP):(from 30 weeks up to 34 weeks)
研究者
Yeliz CAKIR KOCAK
Midwifery Research Asistant
Ege University