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TENS Efficacy in Pain Relief During Hysteroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04229576
Recruitment Status : Completed
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Ebtihal Sameih Ali Alnomany, Ain Shams University

Tracking Information
First Submitted Date  ICMJE January 12, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE March 1, 2019
Actual Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2020)
  • Level of pain:visual analog scale [ Time Frame: 5 minutes after procedures ]
    Using visual analog scale VAS; 0 mm=no pain and 100 mm=worst possible pain).
  • Verbal likert scale [ Time Frame: 5 minutes after procedures ]
    A discrete, 5-point, verbal Likert scale including the following options: "no pain," "minimal pain," "moderate pain," "severe pain," and "worst pain possible," was also used to assess the internal consistency of the pain rating within the study.
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
Level of pain:visual analog scale [ Time Frame: 5 minutes after procedures ]
Using visual analog scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2020)
  • Pain during procedures [ Time Frame: 5 minutes after procedures ]
    The pain of hysteroscopy entry, contact, and biopsy.
  • The duration of procedures [ Time Frame: 5 minutes after procedures ]
    The duration of procesures
  • vital parameters [ Time Frame: 5 minutes after procedures ]
    Blood pressure
  • Vital parameters [ Time Frame: 5 minutes after procedures ]
    Heart rate
  • Vital parameters [ Time Frame: 5 minutes after saturation ]
    Arterial oxygen saturation
  • Vasovagal symptoms [ Time Frame: 5 minutes after procedures ]
    vasovagal symptoms (dizziness, nausea, vomiting, shoulder pain, vertigo, sweating, or fainting)
  • TENS advers effect [ Time Frame: 5 minutes after procedures ]
    unusual or adverse TENS events (skin allergy, pain, or burning at the electrode site) will be recorded during all the hysteroscopy procedures.
  • Level of satisfaction [ Time Frame: 5 minutes after procedures ]
    Finally, the level of satisfaction with the hysteroscopy, as indicated on a scale of ( 0-10), was measured at the end of the procedure .
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TENS Efficacy in Pain Relief During Hysteroscopy
Official Title  ICMJE Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation : Randomized Controlled Trial
Brief Summary Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation : Randomized controlled trial
Detailed Description

Patients fulfilling inclusion criteria will be distributed in two groups, each one will be (60) patients (more than sample size number) to avoid the drop in the size of the study.

Group (A):(60) Active TENS during office hysteroscopy. Group (B)(60) placebo TENS during office hysteroscopy. The active TENS intervention consisted of a varying high-frequency (80-100 Hz), pulse duration 400-microseconds.Transcutaneous electrical nerve stimulation therapy will be initiated 5 minutes before starting the hysteroscopy and for the duration of the procedure. Two sets of two self-adhesive electrodes (circular pads) will be placed parallel to the spinal cord at the T10-L1 and S2-S4 levels .

Group (A)(60) Active TENs during office hysteroscopy The device intensity (amplitude) will be individually adjusted to each participant's maximum sensory level (strongest reported tingling feeling without pain and with no muscle contractions. Patients will be informed about the importance of maintaining the stimulation at a maximum non painful level. Thus, the TENS output intensity will be increased during the treatment every time the patient accommodated to the TENS stimulus. All the hysteroscopies will be performed by the same experienced consultant in (ECDU), who will be blinded to the patients' group allocations. Uterine cavity will be distended with normal saline

Group (B):(60) placebo TENs during office hysteroscopy To achieve blinding in the placebo group, participants will be connected to the TENS unit in exactly the same way as participants in the active TENS group with the unit emitting the active indicator light and sound but delivering no electrical stimulation.

Primary Outcome Measures :

The level of pain at the end of office hysteroscopy procedure (primary outcome) will be measured 5 minutes after procedure on a 100-mm-long horizontal line visual analog scale (VAS; 0 mm=no pain and 100 mm=worst possible pain).

A discrete, 5-point, verbal Likert scale including the following options: "no pain," "minimal pain," "moderate pain," "severe pain," and "worst pain possible," will be used to assess the internal consistency of the pain rating 5 minutes after procedure.

Secondary Outcome Measures The pain of hysteroscopy entry, contact, and biopsy. The duration of the procedure, vital parameters (blood pressure, heart rate, arterial oxygen saturation), vasovagal symptoms (dizzin ess, nausea, vomiting, shoulder pain, vertigo, sweating, or fainting), and unusual or adverse TENS events (skin allergy, pain, or burning at the electrode site) will be recorded during all the hysteroscopy procedures.

Finally, the level of satisfaction with the hysteroscopy, as indicated on a scale of ( 0-10), was measured at the end of the procedure .

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE Device: TENs
Assessing the efficacy of TENs in pain relieve during office hysteroscopy .
Study Arms  ICMJE
  • Active Comparator: Using TENS to relief pain during hystroscopy
    device intensity (amplitude) will be individually adjusted to each participant's maximum sensory level (strongest reported tingling feeling without pain and with no muscle contractions, the TENS output intensity will be increased during the treatment every time the patient accommodated to the TENS stimulus.
    Intervention: Device: TENs
  • Placebo Comparator: Using placebo TENS (not active) during hystroscopy
    participants will be connected to the TENS unit in exactly the same way as participants in the active TENS group with the unit emitting the active indicator light and sound but delivering no electrical stimulation.
    Intervention: Device: TENs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2020)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 30, 2019
Actual Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal endometrial thickening >4mm.
  • Suspicious endometrial polyp or leiomyoma.
  • Infertility study.
  • Menstrual disorder.
  • Suspicious endometrial carcinoma

Exclusion Criteria:

  • • Genital infection.

    • Undiagnosed genital bleeding.
    • Contraindication to office hysteroscopy.
    • Previous cervical surgery.
    • Neurological deficit.
    • Chronic or preprocedural use of opioids or psychoactive drugs.
    • Previous experience in TENS.
    • Cutaneous damage on the application sites.
    • Pacemakers or automatic implanted cardiac defibrillators.
    • Refusal to sign the informed consent form.
    • Inability to understand informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04229576
Other Study ID Numbers  ICMJE TENS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All primary and secondery outcomes will be made available
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Completed study
Access Criteria: Data access will be reviewed by an external independant review panel. Requests will be required to sign a data access agreement
Responsible Party Ebtihal Sameih Ali Alnomany, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ebtihal Sa Ali Ain Shams University
PRS Account Ain Shams University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP