This randomized clinical trial was conducted to evaluate whether use of music could reduce labor pain. Between 2013 and 2014, a total of 140 women at 37 weeks or greater with spontaneous labor that had not conterandication of vaginal delivery were randomized to music and control groups.Fast music without words was played for M grou.Routine cares were used for control group. Labor pain was assessed on a visual analogue scale (VAS) at beginning of the active phase and then every 1 hour. Duration of active phase of labor and route of delivery were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306108151N5
Registration date:2013-06-24, 1392/04/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-24, 1392/04/03
Registrant information
Name
Ladan Ajori
Name of organization / entity
Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 1694
Email address
ajori@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Science
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of fast beat music on labor
Public title
Effects of music on labor
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria are: gestational age between 37 and 42 weeks; singelton pregnancy ;estimated fetal weight between 2500 and 4000 geram; normal fetal heart rate; cephalic presentation; spontaneous onset of labor. The exclusion criteria are: using analgesics and opium within 48 hours before admission; previous cesarean section; conterandications of vaginal delivery; indications of induction or stimulation of labor; psychological disorders ; hearing loss and indications of emergency termination of pregnancy.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Shahid Beheshti University of Medical Science
Street address
Yaman street, Chamran highway
City
Tehran
Postal code
Approval date
2011-10-03, 1390/07/11
Ethics committee reference number
90-1-11282
Health conditions studied
1
Description of health condition studied
labor
ICD-10 code
O63
ICD-10 code description
long labour
Primary outcomes
1
Description
duration of active phase
Timepoint
from 4 centimeter dilatation of cervix to full dilatation
Method of measurement
minutes
Secondary outcomes
1
Description
cesarean rate
Timepoint
at the last of study
Method of measurement
hospital documents
2
Description
labor pain
Timepoint
at the begining of active phase and then every 1 hour
Method of measurement
VAS score
3
Description
maternal complications
Timepoint
at the last of study
Method of measurement
hospital documents
4
Description
fetal complications
Timepoint
at the last of study
Method of measurement
hospital documents
5
Description
neonatal Apgar
Timepoint
first and fifth minutes after birth
Method of measurement
Apgar score
Intervention groups
1
Description
fast music ( intervention group )
Category
Treatment - Other
2
Description
standard care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Leila Nazari
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Seyyed Jalaledin Khoshnevis
Street address
Shohada Tajrish Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Science
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 Science
Full name of responsible person
Leila Nazari
Position
Gynecologist
Other areas of specialty/work
Street address
Shohada Tajrish Hospital
City
Tehran
Postal code
Phone
+98 21 2271 8001
Fax
Email
leynaz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Ladan Ajori
Position
Associated professor
Other areas of specialty/work
Street address
Shohada Tajrish Hospital
City
Tehran
Postal code
Phone
+98 21 2271 8005
Fax
Email
ajori@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Leila Nazari
Position
Gynecologist
Other areas of specialty/work
Street address
Shohada Tajrish Hospital
City
Tehran
Postal code
Phone
+98 21 2271 8001
Fax
Email
leynaz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)