<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/NCT01664988</url>
  </required_header>
  <id_info>
    <org_study_id>muscular relaxation</org_study_id>
    <nct_id>NCT01664988</nct_id>
  </id_info>
  <brief_title>Effect of Muscular Relaxation and Breathing Technique on Blood Pressure in Pregnancy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mashhad University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mashhad University of Medical Sciences</source>
  <brief_summary>
    <textblock>
      Gestational hypertension is the main cause of maternal and fetal mortality, however, it has&#xD;
      no definite effective treatment. nowadays, the stress management approaches are use for&#xD;
      essential hypertension. So, this study aimed is study the effect of progressive muscular&#xD;
      relaxation and breathing control technique on blood pressure during pregnancy.&#xD;
&#xD;
      this 3-groups clinical trial has been done in Mashhad Health Centers and Governmental&#xD;
      hospitals. 60 pregnant women with systolic blood pressure less than 135 mm Hg or diastolic&#xD;
      blood pressure more than 85 mm Hg who met inclusion criteria were assigned into three groups&#xD;
      of progressive muscular relaxation, breathing control and control. In tow experiment groups,&#xD;
      exercises were controlled by one day personally and the rest by CD, BP before and after&#xD;
      interventions was controlled for 4 weeks. In control group blood pressure was measured before&#xD;
      and after 15 minutes with no intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>February 2010</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>effect of muscular relaxation</measure>
    <time_frame>up to1 month</time_frame>
    <description>effect of muscular relaxation by check of the blood pressure after muscular relaxation was controlled</description>
  </primary_outcome>
  <primary_outcome>
    <measure>decrease blood pressure</measure>
    <time_frame>up to 1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>time of decreasing blood pressure</measure>
    <time_frame>up to 1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Blood Pressure in Pregnancy</condition>
  <arm_group>
    <arm_group_label>muscular relaxation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>muscular relaxation was done using Jacobson by contracting and relaxing selected groups of muscles until total relaxation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>breath control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>include deep diaphragmatic breathing and decrease breath rate to 6-10/min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>received routine care of clinic or health center and control their blood pressure weekly and use drugs if necessary</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>muscular relaxation</intervention_name>
    <description>muscular relaxation was done using Jacobson by contracting and relaxing selected groups of muscles until total relaxation</description>
    <arm_group_label>muscular relaxation</arm_group_label>
    <other_name>one</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>breath control</intervention_name>
    <description>breathing control techniques include deep diaphragmatic breathing and decrease breath rate to 6-10/min</description>
    <arm_group_label>breath control</arm_group_label>
    <other_name>two</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control (routine care)</intervention_name>
    <description>received routine care of clinic or health center and use drugs if necessary</description>
    <arm_group_label>control</arm_group_label>
    <other_name>3</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  systolic blood pressure ≥ 135mmHg or&#xD;
&#xD;
          -  diastolic blood pressure ≥ 85mmHg&#xD;
&#xD;
          -  absence of severe preeclampsia condition&#xD;
&#xD;
          -  eclampsia&#xD;
&#xD;
          -  absence chronic hypertension&#xD;
&#xD;
          -  gestational age 20-36w&#xD;
&#xD;
          -  single pregnancy&#xD;
&#xD;
          -  have not contraction or bleeding&#xD;
&#xD;
          -  absence of underlying disease and mental disorders&#xD;
&#xD;
          -  absence of polihydramnios&#xD;
&#xD;
          -  hydatiform mole and placenta previa&#xD;
&#xD;
          -  not addicted to drugs, alcohol, mood-altering medicine and cigarette&#xD;
&#xD;
          -  not to use similar relaxation methods and breathing techniques during pregnancy&#xD;
&#xD;
          -  reading and writing literacy&#xD;
&#xD;
          -  have contact number&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  using antihypertensive drugs(for experimental groups)&#xD;
&#xD;
          -  CBR&#xD;
&#xD;
          -  bleeding&#xD;
&#xD;
          -  contraction or watering during study&#xD;
&#xD;
          -  deteriorating of preeclampsia to severe form&#xD;
&#xD;
          -  hospitalization&#xD;
&#xD;
          -  start medical treatment for experiment groups&#xD;
&#xD;
          -  changing mind for continuing with study&#xD;
&#xD;
          -  to be absent in one session of personal instruction for experiment groups do not&#xD;
             exercises more than 3 sessions of relaxation and breathing control at home&#xD;
&#xD;
          -  delivery during 4- week interventions and presence of symptoms such as confusion,&#xD;
             fatigue, feeling of suffocation, pain, blurred vision during doing exercises&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 15, 2012</last_update_submitted>
  <last_update_submitted_qc>August 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mashhad University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>mahboobeh aalami</investigator_full_name>
    <investigator_title>researcher</investigator_title>
  </responsible_party>
  <!-- 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/NCT01664988
org study id: muscular relaxation
nct id: NCT01664988
lead sponsor: 
Gestational hypertension is the main cause of maternal and fetal mortality, however, it has
      no definite effective treatment. nowadays, the stress management approaches are use for
      essential hypertension. So, this study aimed is study the effect of progressive muscular
      relaxation and breathing control technique on blood pressure during pregnancy.

      this 3-groups clinical trial has been done in Mashhad Health Centers and Governmental
      hospitals. 60 pregnant women with systolic blood pressure less than 135 mm Hg or diastolic
      blood pressure more than 85 mm Hg who met inclusion criteria were assigned into three groups
      of progressive muscular relaxation, breathing control and control. In tow experiment groups,
      exercises were controlled by one day personally and the rest by CD, BP before and after
      interventions was controlled for 4 weeks. In control group blood pressure was measured before
      and after 15 minutes with no intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: effect of muscular relaxation
time frame: up to1 month
description: effect of muscular relaxation by check of the blood pressure after muscular relaxation was controlled
measure: decrease blood pressure
time frame: up to 1 month
measure: time of decreasing blood pressure
time frame: up to 1 month
arm group label: muscular relaxation
arm group type: Experimental
description: muscular relaxation was done using Jacobson by contracting and relaxing selected groups of muscles until total relaxation
arm group label: breath control
arm group type: Experimental
description: include deep diaphragmatic breathing and decrease breath rate to 6-10/min
arm group label: control
arm group type: Other
description: received routine care of clinic or health center and control their blood pressure weekly and use drugs if necessary
intervention type: Behavioral
intervention name: muscular relaxation
description: muscular relaxation was done using Jacobson by contracting and relaxing selected groups of muscles until total relaxation
arm group label: muscular relaxation
other name: one
intervention type: Behavioral
intervention name: breath control
description: breathing control techniques include deep diaphragmatic breathing and decrease breath rate to 6-10/min
arm group label: breath control
other name: two
intervention type: Other
intervention name: control (routine care)
description: received routine care of clinic or health center and use drugs if necessary
arm group label: control
other name: 3
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Mashhad University of Medical Sciences
investigator full name: mahboobeh aalami
investigator title: researcher