History
# Registration date Revision Id
2 2018-03-14, 1396/12/23 45122
1 2018-02-17, 1396/11/28 37438
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
The aim of this study is to determine the effect of percutaneous electrical nerve stimulation on post episiotomy pain.
Design
This study is a clinical trial with random allocation that in this study 80 nuliparous women were randomly divided into two control and intervention group.
Settings and conduct
This study is a triple-blind clinical trial that samples of their belonging to a control group or the intervention are unaware and pain evaluation and analysis of statistical data, respectively, by a research associate and Statistics Consultant, that unaware of the Belonging to the intervention group or control people will be done. For evaluation of pain severity numerical rating scale will be used
Participants/Inclusion and exclusion criteria
Inclusion criteria: The desire to participate in the study, age above 18 years, at least the reading and writing skills, not obese mother, awareness of time and space, nulliparous low-risk pregnancy, singleton pregnancy, gestational age 42-38 weeks, presentation cephalic and anterior occiput, birth weight 4000-2500 grams, infant alive, well and without anomalies, spontaneous vaginal delivery ( without use of vacuum and forceps) with mediolateral episiotomy, presenting pain in the episiotomy area (pain score 4 or more), absence of any genitourinary pathology, non use of epidural anesthesia, normal during the first, second and third stage of labor, non use of sedatives over the last 6 hours before study, lack of experience of TENS use, no history of epilepsy and mental disease, lack of cardiac pacemaker or cardiac arrhythmia disease, lack of drug addiction and smoking. Exclusion criteria: Mother's request to exit at any stage of the study, the skin incision episiotomy more than 5 cm and less than 3 cm, banning the use of TENS like there is an open wound, side effects of TENS (burns, wounds, skin allergy), use of analgesics during data collection, delivery complications (abnormal postpartum bleeding, signs of infection, fever).
Intervention groups
In both groups pain will be determined before intervention. Then in the intervention group transcutaneous nerve stimulation electrode will be insert and will be used for 60 minutes. After that pain will be assessed during four specific time: before applying TENS, 30 minutes, 60 minutes and 120 minutes after removing TENS, at rest and activity (sitting and walking), pain severity, TENS side effects and blood pressure, respiratory rate and pulse rate will be evaluated.
Main outcome variables
Pain; Vital sign; side effect of TENS

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171224038034N1
Registration date: 2018-02-17, 1396/11/28
Registration timing: prospective

Last update: 2018-02-17, 1396/11/28
Update count: 1
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Soma Zakaryaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3316 1616
Email address
zakaryaei.s@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-20, 1397/01/31
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Transcutaneous Electrical Nerve Stimulation in post-episiotomy pain
Public title
Effect of Transcutaneous Electrical Nerve Stimulation in post-episiotomy pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study Age above 18 years At least the reading and writing skills Not obese mother Awareness of time and space Nulliparous low-risk pregnancy Singleton pregnancy Gestational age 42-38 weeks Presentation cephalic and anterior occiput birth weight 4000-2500 grams infant alive, well and without anomalies spontaneous vaginal delivery ( without use of vacuum and forceps) with mediolateral episiotomy presenting pain in the episiotomy area (pain score 4 or more) absence of any genitourinary pathology non use of epidural anesthesia Normal during the first, second and third stage of labor non use of sedatives over the last 6 hours before study lack of experience of TENS use no history of epilepsy and mental disease lack of cardiac pacemaker or cardiac arrhythmia disease lack of drug addiction and smoking
Exclusion criteria:
Mother's request to exit at any stage of the study the skin incision episiotomy more than 5 cm and less than 3 cm banning the use of TENS like there is an open wound side effects of TENS (burns, wounds, skin allergy) use of analgesics during data collection delivery complications (abnormal postpartum bleeding, signs of infection, fever)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Using Blocked Randomization for randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
Samples of their belonging to a control group or the intervention are unaware and pain evaluation and analysis of statistical data, respectively, by a research associate and Statistics Consultant, that unaware of the Belonging to the intervention group or control people will be done
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences , Pasdaran Street, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66166
Approval date
2018-02-04, 1396/11/15
Ethics committee reference number
IR.MUK.REC.1396/318

Health conditions studied

1

Description of health condition studied
Pain after episiotomy
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain

Primary outcomes

1

Description
Pain severity after episiotomy
Timepoint
evaluating pain severity in before applying TENS, 30 minutes, 60 minutes and 120 minutes after removing TENS, at rest and activity (sitting and walking)
Method of measurement
NRS

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The transcutaneous electrical nerve stimulation electrodes, 6-24 hours after episiotomy, will be insert in parallel, near the episiotomy, in the region of the pudendal and genitofemoral nerve and device will be on for 60 minutes, after that pain will be assessed again during four specific time: before applying TENS, 30 minutes, 60 minutes and 120 minutes after removing TENS, at rest and activity (sitting and walking).
Category
N/A

2

Description
Control group: In this group electrodes will be insert at the same place as intervention group but device will be off and the evaluation is as the same.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat hospital of Sanandaj, Kurdistan University of Medical Sciences
Full name of responsible person
Seyedeh Soma Zakaryaee
Street address
Kurdistan University of Medical Sciences, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66166
Phone
+98 87 3366 1120
Fax
+98 87 3366 0092
Email
ss.zakaryaee@gmail.com
Web page address
http://www.muk.ac.ir/Muk.aspx

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr Rezaei
Street address
Kurdistan University of Medical Sciences Pasdaran street, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66166
Phone
+98 87 3366 1120
Fax
+98 87 3366 0092
Email
ss.zakaryaee@gmail.com
Web page address
http://www.muk.ac.ir/Muk.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kurdistan 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
Sanandaj University of Medical Sciences
Full name of responsible person
Seyedeh Soma Zakaryaee
Position
Student Masters
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kurdistan University of Medical Sciences, Pasdaran street, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66166
Phone
+98 87 3366 1120
Fax
+98 87 3366 0092
Email
ss.zakaryaee@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Seyedeh Soma Zakaryaee
Position
student Masters
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kurdistan University of Medical Sciences, Pasdaran street, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66166
Phone
+98 87 3366 1120
Fax
+98 87 3366 0092
Email
ss.zakaryaee@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Seyedeh Soma Zakaryaee
Position
student Masters
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kurdistan University of Medical Sciences, Pasdaran street, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66166
Phone
+98 87 3366 1120
Email
ss.zakaryaee@gmail.com

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
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