NOVasure EXpierences (NOVEX)

NCT06397898 | Completed

• 1 other identifier: N21.091
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

endometrial ablation

Outcome Measures

Primary Outcomes (1)

• Preoperative anxiety

  Preoperative anxiety, measured by the Visual Analogue Scale for Anxiety (VAS-A), is the primary outcome. The VAS is a 100 mm line, and patients are asked to mark their anxiety level on this line. The left end of the line represents "no anxiety," and the right end represents "worst imaginable anxiety." VAS-A is noted in millimeters. Patients fill out the VAS-A form in the hospital shortly before the procedure.

  Patients fill out the VAS-A form in the hospital shortly before the procedure.

Secondary Outcomes (2)

• Preoperative anxiety and the need to obtain information about the procedure and anesthesia.

  Together with the VAS-A, the APAIS is filled out by patients shortly before the procedure.

• To asses patient experiences and satisfaction, related to endometrial ablation.

  two days after post-treatment

Study Arms (2)

Intervention group (video)

EXPERIMENTAL

group that viewed an educational video before Novasure treatment

Other: Educational video

Control group (no video)

NO INTERVENTION

group that did not view an educational video before Novasure treatment

Interventions

Educational video OTHER

Viewing an educational video before Novasure treatment

Intervention group (video)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Treatment for heavy menstrual bleeding with endometrial ablation (Novasure) between the period of March 2022 and May 2024
• Age 18-60 years
• No wish to conceive a pregnancy in the future

You may not qualify if:

• No written informed consent for the interview and distribution of the final educational video which includes relevant pieces from the interview
• Patients that do not speak, read and/or write in Dutch
• Pregnancy

Sponsors & Collaborators

• Maxima Medical Center: lead

Study Sites (1)

Máxima Medical Center

Veldhoven, North Brabant, 5504 BD, Netherlands

Location

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: N.Dkhissi, BA in Medicine, Principal Investigator

Model Details: Randomized-controlled pilot study

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: March 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

NL (1)