<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03002337</url>
  </required_header>
  <id_info>
    <org_study_id>2-102-05-148</org_study_id>
    <nct_id>NCT03002337</nct_id>
  </id_info>
  <brief_title>Efficacy of the Yoga and Aromatherapy on Salivary Hormone and Immune Function in Pregnant Women.</brief_title>
  <official_title>Yoga and Aromatherapy on Salivary Hormone and Immune Function in Pregnant Women.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Defense Medical Center, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Defense Medical Center, Taiwan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study's aims are to examine the effects of yoga and aromatherapy on women's stress and&#xD;
      immune function during pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This longitudinal, prospective, randomized controlled trial recruited 75 healthy pregnant&#xD;
      women from a prenatal clinic in Taipei using convenience sampling. The participants were&#xD;
      randomly assigned to the aromatherapy group (n=25), yoga group (n=25) or control (n=25) group&#xD;
      using Clinstat block randomization.&#xD;
&#xD;
      The aromatherapy group received 70 minutes of aromatherapy massage once biweekly for 20&#xD;
      weeks; the yoga group participated in two weekly 70-minute yoga sessions led by a midwife&#xD;
      certified as a yoga instructor for 20 weeks; the control group received only routine prenatal&#xD;
      care. All participants' salivary cortisol and immunoglobulin A levels were collected before&#xD;
      and after yoga or aromatherapy every 4 weeks from 16 to 36 weeks' gestation.&#xD;
&#xD;
      To collect a sufficient quantity of saliva, we used Salivette® cotton swabs (Salimetrics,&#xD;
      State College, PA, USA), which were stored in double-layer plastic tubes with a lid. When&#xD;
      participants chew a swab for about 2 to 3 minutes, saliva flow is stimulated to a sufficient&#xD;
      amount (1 mL) for collection. After the tube was centrifuged at 1000 x g for 2 minutes,&#xD;
      saliva was stored at -80°C until assay for salivary cortisol and IgA concentrations.&#xD;
&#xD;
      Cortisol was measured using a competitive enzyme-linked immunoassay (ELISA) kit (Cayman&#xD;
      Chemical Company, USA), and salivary IgA was measured using double-antibody sandwich ELISA&#xD;
      method per the manufacturer's instruction (ICL, Inc., USA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physiological parameter (salivary cortisol)</measure>
    <time_frame>20 weeks</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physiological parameter (salivary IgA)</measure>
    <time_frame>20 weeks</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Stress, Psychologic</condition>
  <arm_group>
    <arm_group_label>Aromatherapy massage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ten aromatherapy group received 70 minutes of aromatherapy massage once biweekly by certified aromatherapy therapist for 20 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yoga exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The yoga group participated in two weekly 70-minute yoga sessions led by a midwife certified as a yoga instructor for 20 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>the control group received only routine prenatal care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aromatherapy massage</intervention_name>
    <description>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.</description>
    <arm_group_label>Aromatherapy massage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga exercise</intervention_name>
    <description>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.</description>
    <arm_group_label>Yoga exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal pregnancy&#xD;
&#xD;
          -  Age 20-45 years&#xD;
&#xD;
          -  Agreed to follow-up collections of saliva samples&#xD;
&#xD;
          -  Could read and write Chinese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oral steroid use&#xD;
&#xD;
          -  History of severe illness (e.g., heart disease, systemic lupus erythaematosus,&#xD;
             metabolic disorders) or depression.&#xD;
&#xD;
          -  Drug use (prescribed or illicit).&#xD;
&#xD;
          -  High-risk pregnancy (i.e., first-trimester vaginal bleeding, artificially&#xD;
             insemination, multiple gestations, foetal growth restriction or other abnormalities).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Defense Medical Center, Taiwan</investigator_affiliation>
    <investigator_full_name>Pao-Ju chen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>aromatherapy massage, yoga</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 22, 2016</submitted>
    <returned>February 13, 2017</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03002337
org study id: 2-102-05-148
nct id: NCT03002337
lead sponsor: 
has dmc: No
This study's aims are to examine the effects of yoga and aromatherapy on women's stress and
      immune function during pregnancy.
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).
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Physiological parameter (salivary cortisol)
time frame: 20 weeks
description: 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).
measure: Physiological parameter (salivary IgA)
time frame: 20 weeks
description: 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).
arm group label: Aromatherapy massage
arm group type: Experimental
description: Ten aromatherapy group received 70 minutes of aromatherapy massage once biweekly by certified aromatherapy therapist for 20 weeks.
arm group label: Yoga exercise
arm group type: Experimental
description: The yoga group participated in two weekly 70-minute yoga sessions led by a midwife certified as a yoga instructor for 20 weeks
arm group label: Control
arm group type: No Intervention
description: the control group received only routine prenatal care.
intervention type: Behavioral
intervention name: Aromatherapy massage
description: 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.
arm group label: Aromatherapy massage
intervention type: Behavioral
intervention name: Yoga exercise
description: 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.
arm group label: Yoga exercise
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: National Defense Medical Center, Taiwan
investigator full name: Pao-Ju chen
investigator title: Principal Investigator
mesh term: Stress, Psychological
sharing ipd: No
submitted: December 22, 2016
returned: February 13, 2017