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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01664988
Recruitment Status : Terminated
First Posted : August 15, 2012
Last Update Posted : August 16, 2012
Information provided by (Responsible Party):
mahboobeh aalami, Mashhad University of Medical Sciences

Brief Summary:

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 or disease Intervention/treatment Phase
Blood Pressure in Pregnancy Behavioral: muscular relaxation Behavioral: breath control Other: control (routine care) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : February 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : February 2012

Arm Intervention/treatment
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

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

Primary Outcome Measures :
  1. effect of muscular relaxation [ Time Frame: up to1 month ]
    effect of muscular relaxation by check of the blood pressure after muscular relaxation was controlled

  2. decrease blood pressure [ Time Frame: up to 1 month ]

Secondary Outcome Measures :
  1. time of decreasing blood pressure [ Time Frame: up to 1 month ]

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Responsible Party: mahboobeh aalami, researcher, Mashhad University of Medical Sciences Identifier: NCT01664988     History of Changes
Other Study ID Numbers: muscular relaxation
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: August 16, 2012
Last Verified: August 2012