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

NCT01664988 | Terminated Phase 2

• 1 other identifier: muscular relaxation
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Pressure in Pregnancy

Outcome Measures

Primary Outcomes (2)

• effect of muscular relaxation

  effect of muscular relaxation by check of the blood pressure after muscular relaxation was controlled

  up to1 month

• decrease blood pressure

  up to 1 month

Secondary Outcomes (1)

• time of decreasing blood pressure

  up to 1 month

Study Arms (3)

muscular relaxation

EXPERIMENTAL

muscular relaxation was done using Jacobson by contracting and relaxing selected groups of muscles until total relaxation

Behavioral: muscular relaxation

breath control

EXPERIMENTAL

include deep diaphragmatic breathing and decrease breath rate to 6-10/min

Behavioral: breath control

control

OTHER

received routine care of clinic or health center and control their blood pressure weekly and use drugs if necessary

Other: control (routine care)

Interventions

muscular relaxation BEHAVIORAL

muscular relaxation was done using Jacobson by contracting and relaxing selected groups of muscles until total relaxation

Also known as: one

muscular relaxation

breath control BEHAVIORAL

breathing control techniques include deep diaphragmatic breathing and decrease breath rate to 6-10/min

Also known as: two

breath control

control (routine care) OTHER

received routine care of clinic or health center and use drugs if necessary

Also known as: 3

control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: August 15, 2012
• Study Start: February 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: February 1, 2012
• Last Updated: August 16, 2012

Record last verified: 2012-08