Yoga and Aromatherapy on Salivary Hormone and Immune Function in Pregnant Women.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 75
- Primary Endpoint
- Physiological parameter (salivary cortisol)
Study Overview
Brief Summary
This study's aims are to examine the effects of yoga and aromatherapy on women's stress and immune function during pregnancy.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Normal pregnancy
- •Age 20-45 years
- •Agreed to follow-up collections of saliva samples
- •Could read and write Chinese
Exclusion Criteria
- •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).
Arms & Interventions
Aromatherapy massage
Ten aromatherapy group received 70 minutes of aromatherapy massage once biweekly by certified aromatherapy therapist for 20 weeks.
Intervention: Aromatherapy massage (Behavioral)
Yoga exercise
The yoga group participated in two weekly 70-minute yoga sessions led by a midwife certified as a yoga instructor for 20 weeks
Intervention: Yoga exercise (Behavioral)
Control
the control group received only routine prenatal care.
Outcomes
Primary Outcomes
Physiological parameter (salivary cortisol)
Time Frame: 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).
Secondary Outcomes
- Physiological parameter (salivary IgA)(20 weeks)
Investigators
Pao-Ju chen
Principal Investigator
National Defense Medical Center, Taiwan