Hikita Naoko, Iso Ritsuko, Mizuhata Kiyoko, Isoyama Akemi, Kobayashi Ayumi, Muroi Rika
Department of Health Sciences, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Graduate Program of Midwifery, Dokkyo Medical University, Mibu-machi, Shimotsuga-gun, Tochigi, Japan.
JMIR Res Protoc. 2023 Jan 18;12:e39985. doi: 10.2196/39985.
Foot baths are used in complementary and alternative therapy to improve the duration and quality of sleep and reduce tension, anxiety, fatigue, and confusion. They are also known to improve the frequency of labor contractions and to increase their duration in women; thus, they are commonly used by midwives in clinical settings in Japan. However, the physical and mental effects of foot baths during labor are unknown.
This study aims to assess the physical and mental effects of foot baths based on biomarker levels and self-administered questionnaires.
A single-arm pre-post test trial design is being used in this study, and the study is being conducted at a general hospital in Tochigi Prefecture, Japan. The target study population is women in the first stage of labor, the phase when the uterus starts to contract and when the cervix dilates to 10 cm, or those undergoing labor induction. Participants who meet the eligibility criteria are recruited, and written informed consent is obtained from them. They are asked to answer the questionnaire and to collect 1.5 mL of saliva in 2 microtubes each, before and after the intervention. The intervention is foot baths for 15-20 minutes using a foot bath device. Data on delivery, such as gestational age, gravidity, parity, diagnosis following the last vaginal examination, and presence or absence of membrane rupture, are retrieved from the medical records. The primary outcomes are salivary cortisol levels before and after the foot baths. The secondary outcomes are levels of relaxation and comfort, labor pain, body warmth, vital signs, and interval of labor pain before and after the foot baths, which are assessed using a numerical rating scale. A paired t test or Wilcoxon signed-rank test will be performed to compare the data for salivary cortisol levels and numerical rating scale scores.
Data collection started on April 1, 2022. As of October 2022, we had enrolled 10 participants. Because of the COVID-19 pandemic in Japan, it is difficult for medical personnel to freely interact with women in labor until the results of the COVID-19 polymerase chain reaction test are available in the research facility, complicating the recruitment process.
This is the first prospective study to assess the effects of foot baths using a biomarker during the first stage of labor. The findings on the effects of foot baths on women in labor will provide novel insights that may improve the outcomes of delivery. A randomized controlled trial to investigate the effects of foot baths to obtain robust evidence should be conducted in the future.
University Hospital Medical Information Network-Clinical Trial Registry UMIN000046539; https://tinyurl.com/2wwj7dns.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39985.
足浴被用于补充替代疗法，以改善睡眠时长和质量，减轻紧张、焦虑、疲劳和困惑。人们还知道足浴能提高女性分娩宫缩的频率并延长其持续时间；因此，在日本的临床环境中，助产士经常使用足浴。然而，分娩期间足浴对身心的影响尚不清楚。
本研究旨在根据生物标志物水平和自我管理问卷评估足浴对身心的影响。
本研究采用单臂前后测试试验设计，在日本枥木县的一家综合医院进行。目标研究人群是处于分娩第一阶段的女性，即子宫开始收缩且宫颈扩张至10厘米的阶段，或正在引产的女性。招募符合入选标准的参与者，并获得她们的书面知情同意。要求她们在干预前后回答问卷，并分别在2个微量管中各收集1.5毫升唾液。干预措施是使用足浴设备进行15 - 20分钟的足浴。从病历中获取分娩数据，如孕周、妊娠次数、产次、上次阴道检查后的诊断以及胎膜破裂情况。主要结局是足浴前后的唾液皮质醇水平。次要结局是足浴前后的放松和舒适程度、分娩疼痛、身体温暖度、生命体征以及分娩疼痛间隔，使用数字评分量表进行评估。将进行配对t检验或Wilcoxon符号秩检验，以比较唾液皮质醇水平和数字评分量表分数的数据。
数据收集于2022年4月1日开始。截至2022年10月，我们已招募了10名参与者。由于日本的新冠疫情，在研究机构获得新冠病毒聚合酶链反应检测结果之前，医护人员难以与分娩女性自由互动，这使得招募过程变得复杂。
这是第一项在分娩第一阶段使用生物标志物评估足浴效果的前瞻性研究。关于足浴对分娩女性影响的研究结果将提供新的见解，可能改善分娩结局。未来应进行一项随机对照试验，以研究足浴的效果，从而获得有力证据。
大学医院医学信息网络 - 临床试验注册中心UMIN000046539；https://tinyurl.com/2wwj7dns。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/39985。
