Stress, PsychologicNCT03002337
Efficacy of the Yoga and Aromatherapy on Salivary Hormone and Immune Function in Pregnant Women.
A study testing Aromatherapy massage and Yoga exercise in people with Stress, Psychologic, run by National Defense Medical Center, Taiwan.
Trial summary
This study's aims are to examine the effects of yoga and aromatherapy on women's stress and immune function during pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychologic
- What is being tested?
- Aromatherapy massage and Yoga exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal pregnancy
- Age 20-45 years
- Agreed to follow-up collections of saliva samples
- Could read and write Chinese
Who cannot join
- 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).
About this study
Official title: 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.
Read the 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).
- Conditions
- Stress, Psychologic
- Being tested
- Aromatherapy massage, Yoga exercise
- Keywords
- aromatherapy massage, yoga
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy massageBehavioural
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.
Yoga exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy massage | Experimental | Ten aromatherapy group received 70 minutes of aromatherapy massage once biweekly by certified aromatherapy therapist for 20 weeks. Receives: 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 Receives: Behavioral: Yoga exercise |
| Control | No intervention | the control group received only routine prenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 20 weeks
Secondary outcomes (1)
Physiological parameter (salivary IgA)
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).
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pao-Ju chen, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002337
- Sponsor's protocol ID
- 2-102-05-148
- Status last verified
- Dec 2016
- First submitted
- 19 Dec 2016
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga and Aromatherapy on Salivary Hormone and Immune Function in Pregnant Women.
- ClinicalTrials.gov ID
- NCT03002337
- Acronym / sponsor ID
- 2-102-05-148
- Conditions
- Stress, Psychologic
- Keywords
- aromatherapy massage, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy massage | Experimental | Behavioral: Aromatherapy massageTen aromatherapy group received 70 minutes of aromatherapy massage once biweekly by certified aromatherapy therapist for 20 weeks. |
| Yoga exercise | Experimental | Behavioral: Yoga exerciseThe yoga group participated in two weekly 70-minute yoga sessions led by a midwife certified as a yoga instructor for 20 weeks |
| Control | No intervention | –the control group received only routine prenatal care. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Normal pregnancy
- Age 20-45 years
- Agreed to follow-up collections of saliva samples
- Could read and write Chinese
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatherapy massageAll 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. | Behavioural | Aromatherapy massage |
| Yoga exercisePrenatal 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. | Behavioural | Yoga exercise |
Primary outcome
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).
1 secondary outcome
Physiological parameter (salivary IgA)
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy massage and Yoga exercise in people with Stress, Psychologic, run by National Defense Medical Center, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological parameter (salivary cortisol) (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.