Effect of the Bioheat Patch on Pain Following the HyFoSy Procedure

Not Applicable

Not yet recruiting

• Conditions: Pelvic Pain; Infertility; Pain Management; Gynecologic Procedures

• Registration Number: NCT07081971
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

This randomized controlled trial (RCT) evaluates the efficacy of Bioheat thermal patches in reducing post-procedural pain following Hysterosalpingo Foam Sonography (HyFoSy).

HyFoSy is a common ultrasound-based diagnostic procedure to assess tubal patency and uterine cavity structure in women undergoing fertility workup. While generally less painful than HSG, many patients still report moderate to severe cramping and discomfort during and after the test.

Thermal therapy has demonstrated effectiveness in reducing musculoskeletal and gynecological pain. Bioheat patches, approved by the Israeli Ministry of Health for menstrual pain relief, emit safe, low-grade heat (approximately 37-38°C) and may provide a non-invasive pain management strategy post-HyFoSy.

Participants (n=80) will be women aged 20-45 undergoing HyFoSy. They will be randomly assigned to either the Bioheat intervention group or a placebo patch group, applied externally to the lower abdomen. The heat-producing patch contains iron and other safe materials that react with oxygen to emit continuous heat without electricity. Infrared radiation from the patch components may also promote local vasodilation and muscle relaxation.

Pain assessment will use the validated Visual Analog Scale (VAS), collected post-procedure via follow-up SMS and phone contact. The study aims to quantify reduction in perceived pain, and potentially improve patient satisfaction with HyFoSy. Safety has been pre-established, with no reported adverse skin effects when used as instructed.

Study duration is six months, following ethics approval at the OB-GYN ultrasound department of Shamir Medical Center.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-21
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-22
• Study First Posted: 2025-07-24
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-30
• Study Start: 2025-08-01
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Women aged 18-45 scheduled for HyFoSy

No dermatologic conditions at the patch site

No allergies to patch ingredients, or heat

No active pelvic infections

Exclusion Criteria

Active genital infection

Skin issues in lower abdomen

Sensitivity to heat

Any medical condition preventing local heat use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in pain intensity measured by Visual Analog Scale (VAS)	Up to 6 hours post-procedure	Pain will be assessed using the VAS (range: 0-10; 0 = no pain, 10 = worst imaginable pain). Participants will self-report their score via questionnaire within 6 hours after the procedure.