To assess the effect of listening to music versus no listening to music on the results of non-stress test in pregnant women
Design
This is a randomized clinical trial, in which 160 eligible pregnant women will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible pregnant women who will refer to Fatemieh Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 35 years,
Gestational age 37 to 40 weeks,
Singleton,
First pregnancy,
Low fetal motions
Exclusion criteria:
Pregnancy complications,
Congenital anomalies of the fetus,
Smoking,
Taking sedative or narcotic or anti-anxiety drugs,
Hearing disorder
Intervention groups
Intervention group:
Routine prenatal care as well as listening to the wordless Iranian music called Roohafza generated by Shahram Tavakoli with the IRIB Symphony once for 30 minutes using headphone in a silent room
Control group:
Just routine prenatal care
Main outcome variables
Primary outcome:
The number of fetal heart rate,
The number of fetal movement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N319
Registration date:2019-12-05, 1398/09/14
Registration timing:registered_while_recruiting
Last update:2019-12-05, 1398/09/14
Update count:0
Registration date
2019-12-05, 1398/09/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of listening to music versus no listening to music on the results of non-stress test in pregnant women: a randomized clinical trial
Public title
Effect of listening to music versus no listening to music on the results of non-stress test in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 35 years,
Gestational age 37 to 40 weeks,
Singleton,
First pregnancy,
Low fetal motions
Exclusion criteria:
Pregnancy complications,
Congenital anomalies of the fetus,
Smoking,
Taking sedative or narcotic or anti-anxiety drugs,
Hearing disorder
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:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
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 Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-09-21, 1398/06/30
Ethics committee reference number
IR.UMSHA.REC.1398.426
Health conditions studied
1
Description of health condition studied
Fetal stress
ICD-10 code
O77
ICD-10 code description
Other fetal stress complicating labor and delivery
Primary outcomes
1
Description
The number of fetal heart rate
Timepoint
Before the intervention and 30 minutes after the intervention
Method of measurement
Thorough physical examination
2
Description
The number of fetal movement
Timepoint
Before the intervention and 30 minutes after the intervention
Method of measurement
Thorough physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine prenatal care as well as listening to the wordless Iranian music called Roohafza generated by Shahram Tavakoli with the IRIB Symphony once for 30 minutes using headphone in a silent room
Category
Treatment - Other
2
Description
Control group: Just routine prenatal care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan City
Full name of responsible person
Marzieh Janesari
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
Janesar.m556@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Marzieh Janesari Ladani
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
Janesar.m556@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Batool Khodakarami
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahrabatul2006@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available