Protocol summary
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Study aim
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Determine the effect of transcutaneous electrical nerve stimulation (TENS) on post episiotomy pain
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Design
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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.
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Settings and conduct
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This study is a single blind clinical trial that samples of their belonging to a control group or the intervention are unaware and pain evaluation by a research associate, that unaware of the belonging people to the intervention group or control, will be done. For evaluation of pain severity, the numerical rating scale will be used
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: nulliparous low-risk pregnancy, singleton pregnancy, gestational age 42-38 weeks, spontaneous vaginal delivery with mediolateral episiotomy, presenting pain in the episiotomy area, no use of analgesics during data collection.
Exclusion criteria: side effects of TENS (burns, wounds, skin allergy),Not having epilepsy and mental illness, Not having heart pacemaker and heart disease
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Intervention groups
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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.
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Main outcome variables
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Pain; Vital sign; side effect of transcutaneous electrical nerve stimulation (TENS); Mother's satisfaction
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171224038034N1
Registration date:
2018-02-17, 1396/11/28
Registration timing:
prospective
Last update:
2018-05-12, 1397/02/22
Update count:
1
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Registration date
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2018-02-17, 1396/11/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-04-20, 1397/01/31
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Expected recruitment end date
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2018-08-21, 1397/05/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Transcutaneous electrical nerve stimulatio (TENS) in post-episiotomy pain
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Public title
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Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in post-episiotomy pain
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Nulliparous low-risk pregnancy
Singleton pregnancy
Gestational age 42-38 weeks
spontaneous vaginal delivery ( without use of vacuum and forceps) with mediolateral episiotomy
presenting pain in the episiotomy area (pain score 4 or more)
no use of analgesics during data collection
Exclusion criteria:
side effects of TENS (burns, wounds, skin allergy)
Not having epilepsy and mental illness
Not having heart pacemaker and heart disease
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using Blocked Randomization for randomization
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Samples of their belonging to a control group or the intervention are unaware and pain evaluation by a research associate, that unaware of the Belonging to the intervention group or control people will be done
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-02-04, 1396/11/15
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Ethics committee reference number
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IR.MUK.REC.1396/318
2
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Ethics committee
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Approval date
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2018-02-18, 1396/11/29
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Ethics committee reference number
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IR.MUK.REC.1396/365
Health conditions studied
1
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Description of health condition studied
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Pain after episiotomy
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ICD-10 code
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G89.18
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ICD-10 code description
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Other acute postprocedural pain
Primary outcomes
1
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Description
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Pain severity after episiotomy
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Timepoint
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evaluating pain severity in before applying TENS, 30 minutes, 60 minutes and 120 minutes after removing TENS, at rest and activity (sitting and walking)
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Method of measurement
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NRS
Intervention groups
1
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Description
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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).
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Category
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N/A
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sanandaj University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available