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

NCT03002337 | Completed

• 1 other identifier: 2-102-05-148
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Stress, Psychologic

Keywords

aromatherapy massage, yoga

Outcome Measures

Primary Outcomes (1)

• Physiological parameter (salivary cortisol)

  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).

  20 weeks

Secondary Outcomes (1)

• Physiological parameter (salivary IgA)

  20 weeks

Study Arms (3)

Aromatherapy massage

EXPERIMENTAL

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

Behavioral: Aromatherapy massage

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

Behavioral: Yoga exercise

Control

NO INTERVENTION

the control group received only routine prenatal care.

Interventions

Aromatherapy massage BEHAVIORAL

All of the participants in the aromatherapy group underwent aromatherapy massage for 70 minutes every two weeks between 16 to 36 weeks GA (ten sessions total). The aromatic massage oils were composed of 2 c.c. lavender (Lavandula angustifolia) blended with 98 c.c. almond oil. This concentration of the mixed essential oil was kept at room temperature for massage use.

Aromatherapy massage

Yoga exercise BEHAVIORAL

Prenatal yoga was offered in six 70-minute yoga sessions per week for 20 weeks, with 10-12 women in each session. Each participant should attend two sessions of yoga every two days, held in a quiet room near the prenatal clinic. Yoga specifically designed for women during the second and third trimesters, was guided by a midwife who was certified as a yoga instructor. Yoga included physical postures/ stretch, deep breathing, guided imagery, and deep relaxation. Before each posture/stretch, the instructor guided participants to relax each body part and calm their mind.

Yoga exercise

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 23, 2016
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 23, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share