Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Brief Summary:
Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation : Randomized controlled trial

Condition or disease Intervention/treatment Phase
Pain Device: TENs Not Applicable

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 .

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation : Randomized Controlled Trial
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : August 30, 2019

Arm Intervention/treatment
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.
Device: TENs
Assessing the efficacy of TENs in pain relieve during office hysteroscopy .

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.
Device: TENs
Assessing the efficacy of TENs in pain relieve during office hysteroscopy .




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. Pain during procedures [ Time Frame: 5 minutes after procedures ]
    The pain of hysteroscopy entry, contact, and biopsy.

  2. The duration of procedures [ Time Frame: 5 minutes after procedures ]
    The duration of procesures

  3. vital parameters [ Time Frame: 5 minutes after procedures ]
    Blood pressure

  4. Vital parameters [ Time Frame: 5 minutes after procedures ]
    Heart rate

  5. Vital parameters [ Time Frame: 5 minutes after saturation ]
    Arterial oxygen saturation

  6. Vasovagal symptoms [ Time Frame: 5 minutes after procedures ]
    vasovagal symptoms (dizziness, nausea, vomiting, shoulder pain, vertigo, sweating, or fainting)

  7. 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.

  8. 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 .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229576


Locations
Layout table for location information
Egypt
Ebtihal Sameih Ali Alnomany
Cairo, Egypt, 55500
Sponsors and Collaborators
Ain Shams University
Investigators
Layout table for investigator information
Principal Investigator: Ebtihal Sa Ali Ain Shams University

Layout table for additonal information
Responsible Party: Ebtihal Sameih Ali Alnomany, Principle investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT04229576    
Other Study ID Numbers: TENS
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All primary and secondery outcomes will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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

Layout table for additional information
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