The comparison of two methods of music listening, by mother and fetus on the non-stress test outcome in pregnant women referring to Hafez and Zeinabie hospital of Medical Sciences University of Shiraz 2011.
Objective: The aim of this study was comparison two methods of music listening by mother and fetus on non-stress test outcome.
Study design: single blind clinical trial
Participant selection: Inclusion criteria: gestational age 37- 40 weeks of pregnancy; singleton pregnancy; Women with uncomplicated pregnancies; no chronic disease in mother; not strenuous physical activity until two hours before the test; no use of analgesics, narcotics, sedative and effected drugs on uterine contractions; Before entering the study vibroacoustic stimulation, glucose or fruit juice is not used; at least 1.5 is the last time the mere promise of a meal; no nonreactive non-stress test;
Exclusion criteria: any problem occurred during the study; not wanting to continue more; more than three positive non-stress test.
sample size: 213
Patients are randomly assigned to three 71 member groups including a control and two intervention groups. In the mother intervention group, at the beginning of the second 10 minutes of test the classical music is played. In the Fetal intervention group, also, at the beginning of the second 10 minutes the classical music is played for 15 seconds with three notes trigger and a maximum amplitude of 95 dB, played on the mothers’ belly and the vertex of the fetus. Then the intervention times of these groups and, also, times before and after intervention in each group were compared.
primary outcome : Using Music for mother and fetus will increase acceleration and reduces false-positive results in non-stress test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112108362N1
Registration date:2013-01-21, 1391/11/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-21, 1391/11/02
Registrant information
Name
Roghayeh Khoshkholgh
Name of organization / entity
Shiraz Univercity Medicine of Sience
Country
Iran (Islamic Republic of)
Phone
+98 71 1835 4334
Email address
kholghr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Shiraz University of Medicine Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of two methods of music listening, by mother and fetus on the non-stress test outcome in pregnant women referring to Hafez and Zeinabie hospital of Medical Sciences University of Shiraz 2011.
Public title
The comparison of two methods of music listening, by mother and fetus on the non-stress test outcome.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age range 35-18 years; gestational age 37- 40 weeks of pregnancy; singleton pregnancy; Women with uncomplicated pregnancies include: hypertension disorders, diabetic women requiring insulin, women suspected fetal inter uterine growth restricted, Women after 41 gestational age determinate by last menstruation date or ultrasound 16 to 20 weeks, premature rupture of membranes, multiple pregnancies, intrauterine death fetus, the embryonic lethal anomalies, fetus by cardiovascular anomalies, amniotic fluid disorders, the fetus was diagnosed with anencephaly; baseline of heart rate between 160-110; No pregnant women by loss- hearing; no anatomic or mental disorders in mother (psychosis, schizophrenia, and uterine abnormalities); no chronic disease in mother such as heart disease, lung, kidney, chronic hypertension and diabetes; Not smoking and tobacco; not strenuous physical activity until two hours before the test; no use of analgesics, narcotics, sedative and effected drugs on uterine contractions; Before entering the study vibroacoustic stimulation, glucose or fruit juice is not used; at least 1.5 is the last time the mere promise of a meal; no nonreactive non-stress test; no experience in music education; The written consent form. Exclusion criteria: any problem occurred during the study, including placenta abruption, and cord prolapsed; not wanting to continue more; more than three positive non-stress test (non-reactive); presence of uterine contractions.
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:
213
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
below Namazi Hospital, Zand Avenue
City
Shiraz
Postal code
Approval date
2011-11-11, 1390/08/20
Ethics committee reference number
90-5813-CT
Health conditions studied
1
Description of health condition studied
Nonstress testing in pregnant women
ICD-10 code
w43
ICD-10 code description
expesure to the vibration
Primary outcomes
1
Description
The number of acceleration of fetal heart rate.
Timepoint
Initial 10 minuts of test, second 10 minuts of test.
Method of measurement
Toito Japanese model by fetal echocardiography
Secondary outcomes
1
Description
Reduce of time of nonstress testing
Timepoint
Initial 10 minuts of test, second 10 minuts of test.
Method of measurement
Toito Japanese model by fetal echocardiography
Intervention groups
1
Description
Music intervention in group1 by the mother and music run during the second 10 minutes of nonstress test .and during of test not eating juice by mother or working for reduce mother,s stress.
Category
Treatment - Devices
2
Description
Group 2, intervention of music listening by fetus from mother.s abdominal wall since 15 second after lost of 10 minute of non-stress testing. and during of test not eating juice by mother or working for reduce mother,s stress.
Category
Treatment - Devices
3
Description
Third group is control.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez and Zienabiye Hospital, Shiraz
Full name of responsible person
Keshavarz Tahereh.
Street address
School of Nursing and Midwifery, Namazi Square Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Shiraz University of Medical Sciences
Full name of responsible person
Dr Skandari
Street address
Namazi Hospital, , Zand Avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research 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
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Roghayeh Khoshkholgh
Position
Bachelor of midwifery
Other areas of specialty/work
Street address
Namazi Hospital, Zand Avenue
City
Shiraz
Postal code
Phone
+98 71 1835 4334
Fax
Email
Roghayekhoshkholgh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Keshvarz Tahereh.
Position
Master of midwifry
Other areas of specialty/work
Street address
Sattar-Khan Street, 16th Avenue
City
Shiraz
Postal code
Phone
+98 71 1647 0339
Fax
+98 71 1647 4252
Email
Keshavarzyt@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Roghayeh Khoshkholgh
Position
Bachelor of midwifry
Other areas of specialty/work
Street address
Twenty-meter Ghahremani, Bahonar Crossroad
City
Shiraz
Postal code
Phone
00
Fax
Email
Roghayekhoshkholgh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)