effect of Iranian traditional music on duration of progress of labor according to dilation of cervix from 4cm to full dilation in term pregnancy
Design
Non randomized clinical trial with control gruop; simple sampling; sample size:100
Settings and conduct
Samples would be chosen from 20 to 35 year old, 2nd or 3ed gravid women with term pregnancy who come to Jahrom Motahari hospital in 2018. At the beginning of every 2 hour period music will be played for cases at least for 10 minutes (maximally for 30 min if the patient wants) by a sound player and at the end of each period data such as maternal vital signs, fetal heart rate, signs of labor progress and pain score and anxiety score will be recorded. No intervention will be done for control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 20 to 35 years old women; gravid 2 or 3 with term pregnancy; admitting to Motahari hospital of Jahrom in 2018; gestational age of 37 to 40 weeks; patients desire to participate in the study; low risk pregnancy. Non Inclusion criteria: hearing or speeking disability; medical or psychiatric underlying disease; effective-on-labor chemical or herbal drug consumption in last 24 hours
Intervention groups
Intervention group: music therapy would be done for cases at least for 10 minutes (maximally for 30 min if the pregnant woman wants) and at the end of each period, data will be recorded in the checklist. Control group: no intervention will be done for control group
Main outcome variables
progress of labor based on parkland protocol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150407021653N17
Registration date:2019-01-20, 1397/10/30
Registration timing:registered_while_recruiting
Last update:2019-01-20, 1397/10/30
Update count:0
Registration date
2019-01-20, 1397/10/30
Registrant information
Name
Athar Rasekh Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5432 6602
Email address
a.rasekh@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-20, 1397/09/29
Expected recruitment end date
2019-02-18, 1397/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Iranian traditional music on duration of labor among pregnant women aged 20-35 years old
Public title
effect of iranian music on progress of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20 to 35 years old ladies with gestational age of 37 to 40 weeks(term pregnancy)
Exclusion criteria:
history of medical or psychiatric underlying disease
high risk pregnancy
hearing or speech disability
chemical or herbal drug consumption in past 24 hours(if effective on labor)
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not 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
Ethics committee of Jahrom University of Medical Sciences
Street address
motahari BLV , Jahrom University of Medical Sciences
City
jahrom
Province
Fars
Postal code
4619974148
Approval date
2018-07-31, 1397/05/09
Ethics committee reference number
IR.JUMS.REC.1397.044
Health conditions studied
1
Description of health condition studied
progress of labor
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
progress of labor
Timepoint
each 2 hours
Method of measurement
Digital vaginal exam and labor progress based on parkland protocol
2
Description
pain score
Timepoint
each 2 hours
Method of measurement
Wong-baker pain scale: based on facial grimace and interfering with activity
3
Description
Anxiety scaling
Timepoint
EACH 2 HOURS
Method of measurement
zong anxiety scaling SAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 20 to 35 ladies with term pregnancy who came to Jahrom Motahari hospital will receive music therapy (Bapir by Hosein Alizade and Golden Dreams by Javad Maroufi) by a sound player for at least 10 minutes at the beginning of each 2 hour period. If the patient is satisfied by the listening to the music, it will be continued until 30 minutes.
Category
Rehabilitation
2
Description
Control group: these women receive no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
Dr Athar Rasekh Jahromi
Street address
Motahari hospital, Motahari Blvd,Jahrom,Fars,Iran
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 3004
Email
drrasekh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Doctor Kavous Solhjo
Street address
Jahrom University of Medical Sience, Motahari boluvar, Jahrom
City
Jahrom
Province
Fars
Postal code
4619974148
Phone
+98 71 5434 0406
Email
drrasekh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Doctor Athar Rasekh Jahromi
Position
Obstertrian and gyncologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
The 22 bahman street, Jahrom
City
Jahrom
Province
Fars
Postal code
.
Phone
+98 917 191 1454
Fax
Email
Drrasekh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Doctor Athar Rasekh Jahromi
Position
Obstetricians
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari Street, Jahrom, Fars
City
Jahrom
Province
Fars
Postal code
.
Phone
+98 715426602
Fax
Email
drrasekh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Doctor Athar Rasekh Jahromi
Position
Obstetricians
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari Street, Jahrom, Fars
City
Jahrom
Province
Fars
Postal code
.
Phone
+98 715426602
Fax
Email
drrasekh@yahoo.com
Web page address
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