- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01664988
Effect of Muscular Relaxation and Breathing Technique on Blood Pressure in Pregnancy
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
|
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:
|
|
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:
|
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- muscular relaxation
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