Clinical trial NCT04229576: TENS Efficacy in Pain Relief During Hysteroscopy
Official title: Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation : Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility 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.

Primary outcomes:
measure: Level of pain:visual analog scale
timeFrame: 5 minutes after procedures
measure: Verbal likert scale
timeFrame: 5 minutes after procedures
Secondary outcomes:
measure: Pain during procedures
timeFrame: 5 minutes after procedures
measure: The duration of procedures
timeFrame: 5 minutes after procedures
measure: vital parameters
timeFrame: 5 minutes after procedures
measure: Vital parameters
timeFrame: 5 minutes after procedures
measure: Vital parameters
timeFrame: 5 minutes after saturation
measure: Vasovagal symptoms
timeFrame: 5 minutes after procedures
measure: TENS advers effect
timeFrame: 5 minutes after procedures
measure: Level of satisfaction
timeFrame: 5 minutes after procedures
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ebtihal Sameih Ali Alnomany
Study officials:
affiliation: Ain Shams University
name: Ebtihal Sa Ali
role: PRINCIPAL_INVESTIGATOR
References: