This randomized clinical trial was conducted to evaluate whether use of music could reduce the duration of labor.
Between 2010 and 2011, a total of 99 women at 38 weeks or greater with spontaneous labor that had not conterandication of vaginal delivery were randomized to fast music, slow music and control groups.Music therapy was used with active phase.Routine cares were used for all groups. 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 was recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210138151N3
Registration date:2012-10-29, 1391/08/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-29, 1391/08/08
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
2010-01-30, 1388/11/10
Expected recruitment end date
2011-01-30, 1389/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of fast and slow music on pain and duration of labor: a randomized clinical trial
Public title
Effects of music on pain and duration of labor
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria were cephalic presentation; spontaneous onset of labor; normal pattern of fetal heart rate. The exclusion criteria were intrauterine growth restriction; suspected macrosomia; previous cesarean section or incision of the uterus; multiple pregnancy; malformation of pelvis; psychological disorders; hearing loss, substance abuse; using analgesics within 48 hour before admission and indications of emergency termination of pregnancy by induction of labor or cesarean section.
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:
99
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
Shahid Cahmran highway, Yaman street
City
Tehran
Postal code
Approval date
2009-09-23, 1388/07/01
Ethics committee reference number
196-88
Health conditions studied
1
Description of health condition studied
pain and duration of labor
ICD-10 code
O63
ICD-10 code description
Long labour
Primary outcomes
1
Description
LABOR PAIN
Timepoint
at the begining of active phase and then every 1 hour
Method of measurement
VAS score
2
Description
duration of active phase
Timepoint
from begining of active phase of labor to full dilatation of cervix
Method of measurement
minutes
Secondary outcomes
1
Description
cesarean rate
Timepoint
at the last of study
Method of measurement
hospital documents
2
Description
maternal complications
Timepoint
at the last of study
Method of measurement
history and physical exam
3
Description
fetal complications
Timepoint
at the last od study
Method of measurement
physical exam
4
Description
neonatal Apgar
Timepoint
first and fifth minutes of birth
Method of measurement
Apgar score
Intervention groups
1
Description
fast music - three hours from onset of active phase
Category
Treatment - Other
2
Description
slow music - three hours from onset of active phase
Category
Treatment - Other
3
Description
without music ( control group )
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tajrish hospital
Full name of responsible person
Ladan Ajori
Street address
Tajrish square
City
Tehran
2
Recruitment center
Name of recruitment center
Mahdiyeh hospital
Full name of responsible person
Shabnam Marefat
Street address
Shoosh square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Seyyed Jalaleddin Khoshnevis
Street address
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
Tajrish hospital
City
Tehran
Postal code
Phone
+98 21 2271 8006
Fax
+98 21 2218 1693
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
Gynecologist
Other areas of specialty/work
Street address
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
Tajrish hospital
City
Tehran
Postal code
Phone
+98 21 2271 8006
Fax
Email
leynaz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)