TENS Efficacy in Pain Relief During Hysteroscopy

NCT ID: NCT04229576

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-08-30

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 .

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

TENs

Intervention Type: DEVICE

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

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.

Group Type: PLACEBO_COMPARATOR

TENs

Intervention Type: DEVICE

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

Interventions

TENs

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ebtihal Sameih Ali Alnomany

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebtihal Sa Ali

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ebtihal Sameih Ali Alnomany

Cairo, , Egypt

Countries

Egypt

Other Identifiers

TENS

Identifier Type: -

Identifier Source: org_study_id