Effect of the Bioheat Patch on Pain Following the HyFoSy Procedure

Sponsor
Assaf-Harofeh Medical Center
Study ID
NCT07081971
Status
Not Yet Recruiting

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Conditions

  • Gynecologic Procedures
  • Infertility
  • Pain Management
  • Pelvic Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Bioheat Patch — OTHER
    Bioheat Patch for pain relif
  • Placebo Patch — OTHER
    placebo Patch

Study Details

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.

Key Dates

First listed
Jul 24, 2025
Start date
Aug 1, 2025
Status verified
Jul 2025
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group: 40 women will receive the active Bioheat patch.
  • Experimental: Control Group: 40 women will receive a non-heating placebo patch

Primary Outcome Measure

Change in pain intensity measured by Visual Analog Scale (VAS) [ Time Frame: Up to 6 hours post-procedure ]

Central Contacts

  • Prof. Yaakov Melcer Prof. Yaakov Melcer Principal Investigator shamir Medical, MD
    +972547781821
    [email protected]

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