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NOVasure EXpierences (NOVEX)

NCT06397898 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-05-07

No results posted yet for this study

Summary

Heavy menstrual bleeding (HMB) affects approximately one in four women and imposes considerable social, emotional, physical and economic burdens. Despite various treatment options available, endometrial ablation (Novasure) has emerged as a promising solution, with documented efficacy and high patient satisfaction rates. In the context of peri- and postoperative pain, research has reported that patients experienced less pain during the Novasure endometrial ablation procedure in comparison with two other systems. Moreover, postoperative pain rates were lower in patients treated with Novasure compared to another endometrial ablation device (ThermaChoice system).

Nonetheless, it remains unclear how patients in detail experience the Novasure treatment. It is not clear which factors contribute to either a positive or a negative experience. Moreover, it is unknown if women wish more education before the procedure in order to feel well prepared for the procedure and possible post-procedural symptoms. Therefore, we want to investigate how women with heavy menstrual bleeding experience education about endometrial ablation (Novasure) treatment, the procedure itself and short-term care after treatment.

In this randomized-controlled pilot study, the aim is :

1. To determine if educational videos that show experiences from women with HMB that were treated with Novasure endometrial ablation affect preoperative anxiety.
2. To assess if educational videos have an effect on preoperative need for information
3. To explore Novasure pre-, peri- and postoperative patient experiences
4. To define positive and negative factors related to Novasure endometrial ablation
5. To gain insight in factors that could improve patient satisfaction before, during and after Novasure endometrial ablation and to evaluate the educational videos.

Conditions

  • Abnormal Uterine Bleeding

Interventions

OTHER

Educational video

Viewing an educational video before Novasure treatment

Sponsors & Collaborators

  • Maxima Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06397898 on ClinicalTrials.gov