This study is a randomized clinical trial on 150 pregnant women had referred to Shoushtari hospital, Shiraz, Iran, and compares the effect of doula supportive care and acupressure (point BL32) on maternal anxiety and obstetric outcomes. After obtaining informed consent, the eligible women were allocated randomly into three groups (two experimental groups and one control group). Spielberger's test was used to measure anxiety in the three groups. In the first group, the researcher as the doula was beside the mother from her entrance into the department. She reassured the mother, encouraged her, and gave her activity and relaxing positions at different stages of labor. In the second group, in 3-4 and 7-8cm dilatation, the mother was placed in a proper position and BL32 point was pressed. The pressure was continuously and gently applied by both thumbs for 20 minutes. It was applied by the beginning and stopped at the end of the contractions. On the other hand, the control group only received the department's routine care. Birth outcomes in three groups studied.
General information
Acronym
point BL32: bladder 32
IRCT registration information
IRCT registration number:IRCT2013081411706N4
Registration date:2013-09-01, 1392/06/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-01, 1392/06/10
Registrant information
Name
Zahra Masoudi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 7282
Email address
masoudi_z@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Shiraz University of Medical Sciences
Expected recruitment start date
2012-12-05, 1391/09/15
Expected recruitment end date
2013-02-03, 1391/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision the effect of doula supportive care and acupressure (point BL32) on maternal anxiety and obstetric outcomes
Public title
The effect of doula supportive care and acupressure (point BL32) on maternal anxiety and obstetric outcomes
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria of the study: first or second pregnancy; single; term pregnancy; vertex presentation; spontaneous beginning of the delivery process; 3-4 cm cervical dilatation; being 18-35 years old; and having at least middle school degree.The exclusion criteria of the study were suffering from any physical or mental problems; oligohydramnios; preeclampsia; Rh incompatibility; having a history of smoking; thick meconium and maternal diabetes.
Age
From 18 years old to 35 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
Ethics in Medical Research, Shiraz University of Medical Sciences
Street address
Research_seven floors_University of Central Building_ near red crescent_ zand avenue_Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2012-12-05, 1391/09/15
Ethics committee reference number
CT-91-6356
Health conditions studied
1
Description of health condition studied
Mother anxiety
ICD-10 code
F41.0
ICD-10 code description
Panic disorder [episodic paroxysmal anxiety
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
Spielberger questionnaire
2
Description
Duration of the first and second stage of labor
Timepoint
During the intervention
Method of measurement
Per minute
Secondary outcomes
empty
Intervention groups
1
Description
In the first group, the researcher as the doula was beside the mother from her entrance into the department. She reassured the mother, encouraged her, and gave her activity and relaxing positions at different stages of labor.
Category
Treatment - Other
2
Description
In the second group, in 3-4 and 7-8cm dilatation, the mother was placed in a proper position and BL32 point was pressed. The pressure was continuously and gently applied by both thumbs for 20 minutes. It was applied by the beginning and stopped at the end of the contractions
Category
Treatment - Other
3
Description
the control group only received the department's routine care
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shushtari Hospital
Full name of responsible person
andishe jorkesh
Street address
Corner Regiment - Shushtari Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Shiraz University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Hatam
Street address
Research_seven floors_University of Central Building_ near red crescent_ zand avenue_Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Shiraz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Division of Hematology, Oncology and Stem Cell Transplantatio
Full name of responsible person
Dr. Mani Ramzi
Position
Specialty in oncology, Associate
Other areas of specialty/work
Street address
School of Medicine, Zand avenue,Shiraz
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1627 6411
Fax
+98 71 1627 6411
Email
Ramzim@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Univesity Of Medical Science
Full name of responsible person
Zahra Masoudi
Position
Student Master of Midwifery
Other areas of specialty/work
Street address
Fatemeh (P.B.U.H) School Of Nursing & Midwifery, Namazi squear, Shiraz.