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

August 15, 2012 updated by: mahboobeh aalami, Mashhad University of Medical Sciences

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: muscular relaxation
muscular relaxation was done using Jacobson by contracting and relaxing selected groups of muscles until total relaxation
muscular relaxation was done using Jacobson by contracting and relaxing selected groups of muscles until total relaxation
Other Names:
  • one
Experimental: breath control
include deep diaphragmatic breathing and decrease breath rate to 6-10/min
breathing control techniques include deep diaphragmatic breathing and decrease breath rate to 6-10/min
Other Names:
  • two
Other: control
received routine care of clinic or health center and control their blood pressure weekly and use drugs if necessary
received routine care of clinic or health center and use drugs if necessary
Other Names:
  • 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect of muscular relaxation
Time Frame: up to1 month
effect of muscular relaxation by check of the blood pressure after muscular relaxation was controlled
up to1 month
decrease blood pressure
Time Frame: up to 1 month
up to 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
time of decreasing blood pressure
Time Frame: up to 1 month
up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

July 24, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 15, 2012

Study Record Updates

Last Update Posted (Estimate)

August 16, 2012

Last Update Submitted That Met QC Criteria

August 15, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • muscular relaxation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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