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

N

National Defense Medical Center, Taiwan

Status

Completed

Conditions

Stress, Psychologic

Treatments

Behavioral: Yoga exercise
Behavioral: Aromatherapy massage

Study type

Interventional

Funder types

Other

Identifiers

NCT03002337
2-102-05-148

Details and patient eligibility

About

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

Full 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).

Enrollment

75 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

75 participants in 3 patient groups

Aromatherapy massage
Experimental group
Description:
Ten aromatherapy group received 70 minutes of aromatherapy massage once biweekly by certified aromatherapy therapist for 20 weeks.
Treatment:
Behavioral: Aromatherapy massage
Yoga exercise
Experimental group
Description:
The yoga group participated in two weekly 70-minute yoga sessions led by a midwife certified as a yoga instructor for 20 weeks
Treatment:
Behavioral: Yoga exercise
Control
No Intervention group
Description:
the control group received only routine prenatal care.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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