TENS Efficacy in Pain Relief During Hysteroscopy

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

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: TENs

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: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 55500
    • Ebtihal Sameih Ali Alnomany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of pain:visual analog scale	Using visual analog scale VAS; 0 mm=no pain and 100 mm=worst possible pain).	5 minutes after procedures
Verbal likert scale	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.	5 minutes after procedures

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during procedures	The pain of hysteroscopy entry, contact, and biopsy.	5 minutes after procedures
The duration of procedures	The duration of procesures	5 minutes after procedures
vital parameters	Blood pressure	5 minutes after procedures
Vital parameters	Heart rate	5 minutes after procedures
Vital parameters	Arterial oxygen saturation	5 minutes after saturation
Vasovagal symptoms	vasovagal symptoms (dizziness, nausea, vomiting, shoulder pain, vertigo, sweating, or fainting)	5 minutes after procedures
TENS advers effect	unusual or adverse TENS events (skin allergy, pain, or burning at the electrode site) will be recorded during all the hysteroscopy procedures.	5 minutes after procedures
Level of satisfaction	Finally, the level of satisfaction with the hysteroscopy, as indicated on a scale of ( 0-10), was measured at the end of the procedure .	5 minutes after procedures

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Ebtihal Sa Ali, ain shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): July 30, 2019
• Study Completion (ACTUAL): August 30, 2019

Study Registration Dates

• First Submitted: January 12, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (ACTUAL): January 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: TENS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All primary and secondery outcomes will be made available
• IPD Sharing Time Frame: Completed study
• IPD Sharing Access Criteria: Data access will be reviewed by an external independant review panel. Requests will be required to sign a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• 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