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Completed

NCT Number: NCT04229576

TENS Efficacy in Pain Relief During Hysteroscopy

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ebtihal Sameih Ali Alnomany

Cairo, 55500, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TENS

Device

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

Primary outcomes

  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 outcomes

  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 .

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation : Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2020
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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