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临床试验/NCT03002337
NCT03002337已完成不适用

Yoga and Aromatherapy on Salivary Hormone and Immune Function in Pregnant Women.

National Defense Medical Center, Taiwan0 个研究点目标入组 75 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
主要终点
Physiological parameter (salivary cortisol)

研究概览

简要总结

This study's aims are to examine the effects of yoga and aromatherapy on women's stress and immune function during pregnancy.

详细描述

This longitudinal, prospective, randomized controlled trial recruited 75 healthy pregnant women from a prenatal clinic in Taipei using convenience sampling. The participants were randomly assigned to the aromatherapy group (n=25), yoga group (n=25) or control (n=25) group using Clinstat block randomization.

The aromatherapy group received 70 minutes of aromatherapy massage once biweekly for 20 weeks; the yoga group participated in two weekly 70-minute yoga sessions led by a midwife certified as a yoga instructor for 20 weeks; the control group received only routine prenatal care. All participants' salivary cortisol and immunoglobulin A levels were collected before and after yoga or aromatherapy every 4 weeks from 16 to 36 weeks' gestation.

To collect a sufficient quantity of saliva, we used Salivette® cotton swabs (Salimetrics, State College, PA, USA), which were stored in double-layer plastic tubes with a lid. When participants chew a swab for about 2 to 3 minutes, saliva flow is stimulated to a sufficient amount (1 mL) for collection. After the tube was centrifuged at 1000 x g for 2 minutes, saliva was stored at -80°C until assay for salivary cortisol and IgA concentrations.

Cortisol was measured using a competitive enzyme-linked immunoassay (ELISA) kit (Cayman Chemical Company, USA), and salivary IgA was measured using double-antibody sandwich ELISA method per the manufacturer's instruction (ICL, Inc., USA).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
None

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

  • •Normal pregnancy
  • •Age 20-45 years
  • •Agreed to follow-up collections of saliva samples
  • •Could read and write Chinese

排除标准

  • •Oral steroid use
  • •History of severe illness (e.g., heart disease, systemic lupus erythaematosus, metabolic disorders) or depression.
  • •Drug use (prescribed or illicit).
  • •High-risk pregnancy (i.e., first-trimester vaginal bleeding, artificially insemination, multiple gestations, foetal growth restriction or other abnormalities).

研究组 & 干预措施

Aromatherapy massage

Experimental

Ten aromatherapy group received 70 minutes of aromatherapy massage once biweekly by certified aromatherapy therapist for 20 weeks.

干预措施: Aromatherapy massage (Behavioral)

Yoga exercise

Experimental

The yoga group participated in two weekly 70-minute yoga sessions led by a midwife certified as a yoga instructor for 20 weeks

干预措施: Yoga exercise (Behavioral)

Control

No Intervention

the control group received only routine prenatal care.

结局指标

主要结局

Physiological parameter (salivary cortisol)

时间窗: 20 weeks

This study used salivary cortisol as the indicator of stress. To assess stress in this study, the concentrations of cortisol (μg/dL) in saliva samples were analysed and was measured using a competitive enzyme-linked immunoassay (ELISA) kit (Cayman Chemical, Ann Arbor, USA). The participants' salivary cortisol levels were collected before and after the intervention group received aromatherapy massage (every month from 16 to 36 weeks gestation).

次要结局

  • Physiological parameter (salivary IgA)(20 weeks)

研究者

发起方
National Defense Medical Center, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pao-Ju chen

Principal Investigator

National Defense Medical Center, Taiwan

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