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Comparison of Vibro-Acoustic stimulation, music and Acupressure effects in Non-stress test results and its parameters in pregnant women

Protocol summary

Summary
Objective: To evaluate the effect of Vibro-Acoustic stimulation, Music and Acupressure on the non-stress test results and its parameters (fetal heart rate, the number of acceleration, the time of the first acceleration, results of the test and finally the time of second acceleration). Normal pregnant women in the 32-36 week of gestation that carrying healthy fetuses were included and in the event of any disruption in the health status of the fetus were excluded. The 96 pregnant women (32-36 weeks) in prenatal care unit were selected by randomize sampling for Vibro-Acoustic stimulation (n= 32), Music (n=32) and acupressure (n= 32) during second NST. At first all mothers were taken non-stress test. After a short break, while doing the second non-stress test, intervention done. In Vibro-Acoustic group, with a Diapason stimulate fetuses at the start of the record. In Music group, music was playing through headphones for the mother all the time doing the test. In acupressure group, researcher stimulated BL67 point for 2 minutes and after 5 min repeats it, immediately after the stimulations, carries out the test.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012092310913N1
Registration date: 2012-10-02, 1391/07/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-10-02, 1391/07/11
Registrant information
Name
Masoume Pirhadi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1357 9577
Email address
pirhadi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Vibro-Acoustic stimulation, music and Acupressure effects in Non-stress test results and its parameters in pregnant women
Public title
Effects of Vibro-Acoustic stimulation, music and Acupressure in Non-stress test
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:18-35 years old women; primigravide women; 32-36 weaks gestation; singele pregnancy; having no history of infertility; did not pregnant with ART methods; women with no complications during pregnancy;no smoking woman; using any drugs; feeding atleast 2 houres before sampling; regullar prenatal care; having 50 min free exclusion criteria: having no interest to countinue the study; accure any problem with mothers or their fetuses; record any unexplained result
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: 96
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
Isfahan University of Medical Sciences, Isfahan, Iran
Street address
Hezar Jarib Ave
City
Isfahan
Postal code
Approval date
2011-08-11, 1390/05/20
Ethics committee reference number
390336

Health conditions studied

1

Description of health condition studied
Fetal health
ICD-10 code
O35
ICD-10 code description
Maternal care for known or suspected fetal abnormality and damage

2

Description of health condition studied
Fetal health
ICD-10 code
O36
ICD-10 code description
Maternal care for other known or suspected fetal problems

Primary outcomes

1

Description
fetal heart rate baseline
Timepoint
20 min first, after 5 minutes interval, take second test in 20 min
Method of measurement
with fetal monitoring

2

Description
time of the first acceleration
Timepoint
20 min first, after 5 minutes interval, take second test in 20 min
Method of measurement
fetal monitoring

3

Description
number of acceleration
Timepoint
20 min first, after 5 minutes interval, take second test in 20 min
Method of measurement
fetal monitoring

4

Description
result of non stress test
Timepoint
20 min first, after 5 minutes interval, take second test in 20 min
Method of measurement
fetal monitoring

5

Description
time of second acceleration
Timepoint
20 min first, after 5 minutes interval, take second test in 20 min
Method of measurement
fetal monitoring

Secondary outcomes

empty

Intervention groups

1

Description
Vibro-Acoustic stimulation after first non stress test, with a Diapason stimulate fetuses at the start of the record of second non stress test.
Category
Diagnosis

2

Description
Music after the first non stress test, music was playing through headphones for the mother all the time doing the second non stress test
Category
Diagnosis

3

Description
Acupressure researcher stimulated BL67 point for 2 minutes and after 5 min repeats it, immediately after the stimulations, carries out the test.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Shahshahan Zahra, Department of Obstetric & Gynecology, Faculty Member of Medicine School,Isfahan
Street address
Beheshti hospital- Motahari Ave.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran.
Full name of responsible person
Maryam Kianpour
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
390336
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Isfahan, Iran.
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
Isfahan University of Medical Sciences
Full name of responsible person
Valiani Mahboubeh
Position
MSc, Department of Midwifery, FacultyMember, School of Nursing and Midwifery, Isfahan University of
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan University of Medical Sciences
Postal code
Phone
+98 31 1792 2918
Fax
Email
valiani@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran.
Full name of responsible person
Valiani Mahboubeh
Position
MSc
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2918
Fax
Email
valiani@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Masoumeh Pirhadi
Position
MSc Student
Other areas of specialty/work
Street address
No 37, Golriz st., Shahid Rajaee Ave
City
Khomeini Shahr
Postal code
8414764361
Phone
+98 31 1357 9577
Fax
+98 31 1357 9577
Email
pirhadi@nm.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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