Abstract
Background and Objectives: Prenatal maternal anxiety has adverse effects on the mother and fetus and child. Use of anxiety-reducing techniques for pregnant mothers plays an important role in decreasing maternal and child Psychological problems. Relaxation exercise could be improve pregnancy outcome in High Risk pregnancy and High Risk Delivery. This study aimed to determine the effect of relaxation training on anxiety in High risk mothers.
Methods :The present study was done as a clinical trial on 150 High Risk Pregnant Women 32-35week (75 subjects as relaxation group,75 subjects as control group)referred to Health and Medical Center in Shahreza city.Data were collected using personal data form and Spielberger anxiety Inventory questionnaire .In addition to routine pregnancy care, four 90minute sessions of relaxation active Jacobson training courses were held during 4weeks (once a week). The control group only received routine pregnancy care .Anxiety score before the intervention and at the end of the intervention were analyzed in all two groups .Data analysis was done using Chi-square,T-test , exact ’fisher analysis.
Results: In this study, the mean anxiety scores were not significantly different in the two groups before the intervention ,but there was significant differences in relaxation group after the intervention (p-value<0/001). There was a decrease in the mean anxiety score in relaxation group after the intervention whereas there was a slightly increase in the control group.
Conclusion: The results of this study indicated that relaxation training could reduce anxiety in Pregnant High Risk Women.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121015737N1
Registration date:2014-04-27, 1393/02/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-27, 1393/02/07
Registrant information
Name
farzah rahimi
Name of organization / entity
Martyr Beheshti University of Medical Sciences International Branch
Country
Iran (Islamic Republic of)
Phone
+98 32 1324 2593
Email address
m.ahmadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
International Branch of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of relaxation training on anxiety of pregnant women in high risk groups
Public title
Effect of relaxation training on anxiety of pregnant women in high risk groups
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having the ability to read and write ؛ no history of mental illness ؛ not taking Anti-anxiety drugs؛ a gestational age between 32-35weeks (the exact date of the first day of the last menstrual period or ultrasound 20 weeks) ؛ Having low to moderate anxiety score (21-60) on the STAI anxiety scale ؛ lack of relaxation before or during the study ؛ the pregnant mother is high risk pregnancy groups.Exclusion criteria: non-compliance with the study protocol (the absence of a training session or non-performance of Relaxation at home for more than two days a week)
Age
From 16 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
International Branch of Shahid Beheshti University of Medical Sciences
Street address
No19,Shahid Abbassour Street,Vali asr Street,Tehran ,Iran
City
Tehran
Postal code
141553693
Approval date
2013-09-30, 1392/07/08
Ethics committee reference number
116/2682
Health conditions studied
1
Description of health condition studied
pregnancy anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Pregnancy anxiety
Timepoint
Before and after intervention
Method of measurement
Questionair
Secondary outcomes
empty
Intervention groups
1
Description
Intervention groups: receive routine care during pregnancy and four sessions of relaxation
Control groups: receive routine care during pregnancy
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahreza Health centers
Full name of responsible person
Farzaneh rahimi
Street address
Shahreza
City
Shahreza
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
International Branch Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh rahimi
Street address
No19,Shahid Abbasspour street,vali asr street,Tehran,Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International Branch Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahbobeh ahmadi
Position
Master of Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery University,Niyayesh street ,Vali Asr Street,Tehran,Iran
City
Tehran
Postal code
141553693
Phone
+98 21 8820 2512
Fax
Email
mah1372@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahbobeh Ahmadi
Position
Master of Midwifery (Department)
Other areas of specialty/work
Street address
Nursing and Midwifery University,Niyayesh street ,Vali Asr Street,Tehran,Iran
City
Tehran
Postal code
14155-3693
Phone
+98 21 8820 2512
Fax
Email
mah1372@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahbobeh Ahmadi
Position
Master midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery University,Niyayesh street ,Vali Asr Street,Tehran,Iran
City
Tehran
Postal code
141553693
Phone
+98 21 8820 2512
Fax
Email
mah1372@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)