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

December 20, 2016 updated by: Pao-Ju chen, National Defense Medical Center, Taiwan

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aromatherapy massage
Ten aromatherapy group received 70 minutes of aromatherapy massage once biweekly by certified aromatherapy therapist for 20 weeks.
Behavioral: Aromatherapy massage
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.
Experimental: 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
Behavioral: Yoga exercise
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.
No Intervention: Control
the control group received only routine prenatal care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
20 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physiological parameter (salivary IgA)
Time Frame: 20 weeks
This study used salivary IgA as the indicator of immune function. To assess immune function in this study, the concentrations of IgA (μg/mL) in saliva samples were analysed and was measured using the double-antibody sandwich ELISA method according to the manufacturer's instructions (ICL, Inc., USA). The participants' salivary immunoglobulin A levels were collected before and after the intervention group received aromatherapy massage (every month from 16 to 36 weeks gestation).
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Defense Medical Center, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2-102-05-148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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