Effect of Muscular Relaxation and Breathing Technique on Blood Pressure in Pregnancy

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
mahboobeh aalami, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01664988
First received: July 24, 2012
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Blood Pressure in Pregnancy
Behavioral: muscular relaxation
Behavioral: breath control
Other: control (routine care)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • effect of muscular relaxation [ Time Frame: up to1 month ] [ Designated as safety issue: Yes ]
    effect of muscular relaxation by check of the blood pressure after muscular relaxation was controlled

  • decrease blood pressure [ Time Frame: up to 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • time of decreasing blood pressure [ Time Frame: up to 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: February 2010
Study Completion Date: February 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: muscular relaxation
muscular relaxation was done using Jacobson by contracting and relaxing selected groups of muscles until total relaxation
Behavioral: muscular relaxation
muscular relaxation was done using Jacobson by contracting and relaxing selected groups of muscles until total relaxation
Other Name: one
Experimental: breath control
include deep diaphragmatic breathing and decrease breath rate to 6-10/min
Behavioral: breath control
breathing control techniques include deep diaphragmatic breathing and decrease breath rate to 6-10/min
Other Name: two
control
received routine care of clinic or health center and control their blood pressure weekly and use drugs if necessary
Other: control (routine care)
received routine care of clinic or health center and use drugs if necessary
Other Name: 3

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • systolic blood pressure ≥ 135mmHg or
  • diastolic blood pressure ≥ 85mmHg
  • absence of severe preeclampsia condition
  • eclampsia
  • absence chronic hypertension
  • gestational age 20-36w
  • single pregnancy
  • have not contraction or bleeding
  • absence of underlying disease and mental disorders
  • absence of polihydramnios
  • hydatiform mole and placenta previa
  • not addicted to drugs, alcohol, mood-altering medicine and cigarette
  • not to use similar relaxation methods and breathing techniques during pregnancy
  • reading and writing literacy
  • have contact number

Exclusion Criteria:

  • using antihypertensive drugs(for experimental groups)
  • CBR
  • bleeding
  • contraction or watering during study
  • deteriorating of preeclampsia to severe form
  • hospitalization
  • start medical treatment for experiment groups
  • changing mind for continuing with study
  • to be absent in one session of personal instruction for experiment groups do not exercises more than 3 sessions of relaxation and breathing control at home
  • delivery during 4- week interventions and presence of symptoms such as confusion, fatigue, feeling of suffocation, pain, blurred vision during doing exercises
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: mahboobeh aalami, researcher, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01664988     History of Changes
Other Study ID Numbers: muscular relaxation
Study First Received: July 24, 2012
Last Updated: August 15, 2012
Health Authority: Iran: regional Ethics Committee of Mashhad university of medical sciences in 2009

ClinicalTrials.gov processed this record on August 20, 2014