Comparison of the effect of TENS and music therapy on pain relief in labor and postpartum
Design
A randomized control trial, community base with 3 groups of TENS(n=50) , music (n=50) and control (n=50), not blinded.
Settings and conduct
women with singleton pregnancy who reffer to Shohada hospital with inclusion criteria would enter to this study. At first the score of pain with VAS ruler will determine. Then women in music group(n=50) will listen to their favorite music during labor until 4 hours after delivery. TENS electrodes will be sticked to lumbar region(T10 - S2) of women in TENS group(n=50) during labor till 4 hours after delivery. Women in control group receive routine care(n=50). Every one hour during labor and every 2 hours during 4 hours after delivery and every 6 hours till 24 hours after delivery, women will be asked about the score of pain according to VAS ruler. In addition length of active phase, stage II of labor, maternal and neonatal complications, neonatal APGAR score, score of pain after delivery, analgesic usage during 24 hours after delivery and patients satisfaction will check and analyze with SPSS 21.
Participants/Inclusion and exclusion criteria
main inclusion criteria:women with singleton pregnancy which begins spontaneous labor pain and they are in the active phase of labor
main exclusion criteria: patient unwillingness of cooperation in the study, indication for augmentation or cesarean section
Intervention groups
TENS(transcutaneous electrical nerve stimulation) group: patients who use TENS during active phase.
Music group: patients who listen to their favorite music during active phase of labor.
Control group: patients who use nothing during active phase.
Main outcome variables
pain score during labor and postpartum; duration of active phase and stage2 of labor, patient satisfaction, analgesic use, APGAR and umbilical cord PH.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160722029027N5
Registration date:2018-05-04, 1397/02/14
Registration timing:retrospective
Last update:2018-05-04, 1397/02/14
Update count:0
Registration date
2018-05-04, 1397/02/14
Registrant information
Name
Leila Nazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
nazari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-21, 1395/06/31
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of TENS and music therapy on pain relief in labor and postpartum: A randomized clinical trial
Public title
Comparison of the effect of TENS and music therapy on pain relief in labor and postpartum: A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
singleton pregnancy
estimated fetal weight 2500-4000
cephalic presentation
normal FHR
no use of analgesic and opium from 48h before entrance into trial
spontaneous labor pain
normal back skin
no history of cesarean section
no contraindication of NVD
no history of cardiorespiratory disease
no history of psychology disorders
no history of hearing disorders
active phase of labor
Exclusion criteria:
patient unwillingness to continue cooperation
indications for augmentation during labor
indications for emergent C/S
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
In this study,the patients will randomly and with random number tables and computerized, divided in 3 groups; TENS, music and control after initiation of active phase of labor
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University
Street address
Shahid chamran highway, Evin, next to Taleghani hospital
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2015-10-12, 1394/07/20
Ethics committee reference number
IR.SBMU.SM.REC.1394.48
Health conditions studied
1
Description of health condition studied
delivery
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery
Primary outcomes
1
Description
Pain score during labor
Timepoint
Before intervention, every 1 hour during active phase of labor till delivery
Method of measurement
visual analogue scale for measurement of pain with questionnaire
2
Description
Pain score in postpartum
Timepoint
Every 2 hours till 4 hours after delivery and every 6 hours till 24 hours after delivery.
Method of measurement
visual analogue scale for measurement of pain with questionnaire
Secondary outcomes
1
Description
Satisfaction
Timepoint
24 hours after delivery
Method of measurement
questionnaire
2
Description
duration of active phase
Timepoint
From entrance to active phase till full dilatation of cervix
Method of measurement
hour
3
Description
duration of stage 2 labor
Timepoint
From full cervical dilatation till delivery
Method of measurement
minuets
4
Description
neonatal APGAR
Timepoint
1 and 5 minutes after birth
Method of measurement
APGAR scoring system
5
Description
Analgesic usage in postpartum
Timepoint
24 hours after delivery
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group 1(TENS:trans cutaneous electrical nerve stimulation): TENS electrodes will stick to lumbar region of patients in this group from T10 to S2, from entrance of active phase till 4 hours after delivery. Electrical impulses are under control of the patient.
Category
Treatment - Devices
2
Description
Intervention group 2(music group): patients in this group will listen to their favorite musics from entrance to the active phase till 4 hours after delivery.
Category
Treatment - Other
3
Description
Control group: patients who enter to active phase of labor which receive routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tajrish shohada's hospital
Full name of responsible person
Dr. Leila Nazari
Street address
Tajrish square
City
Teharn
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
nazari@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
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 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Athena Behforouz
Position
Obstetric and Gynecology resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tajrish square, Shohada's hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
behforouz.a@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
leila nazari
Position
Fellowship of Infertility
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tajrish square, Shohada's hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
nazari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Athena Behforouz
Position
Obstetric and Gynecology resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tajrish square, shohada's hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
behforouz.a@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
IPD collected for the primary outcome measure will be shared
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
increasing the clinical information and for review articles
From where data/document is obtainable
Via email: behforouz.a@gmail.com
What processes are involved for a request to access data/document
Access will be done with the opinion of the professors involved in the work