Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397898
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2024-04-30
Brief Title:
NOVasure EXpierences NOVEX
Sponsor:
Maxima Medical Center
Organization:
Maxima Medical Center
Study Overview
Official Title:
NOVasure Endometrial Ablation Pre- Peri- and Postprocedural Patients EXperiences and Satisfaction for Women With Heavy Menstrual Bleeding the NOVEX Trial A Qualitative Questionnaire Pilot-study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
Procedure
Subjects will be recruited from the outpatient clinic from Máxima Medical Center Eindhoven and Veldhoven Patients presenting with heavy menstrual bleeding and scheduled for endometrial ablation Novasure between March 2022 and April 2024 were approached for study participation either by email phone call or in-person during their clinic visit Upon expressing interest patients will be provided with detailed information about the study and asked to sign an informed consent form Patients were randomized in an alternating order and 11 ratio
Subsequently after randomization the participants will be sent a secure email containing the link to the educational videos Patients will watch the educational videos 1-7 days before their Novasure treatmentOn the day of treatment before undergoing the Novasure procedure patients will complete the Visual Analogue Scale for Anxiety VAS-A and Amsterdam Preoperative Anxiety and Information Scale APAIS
Two days post-treatment the participants will receive a questionnaire via email through Research Manager This questionnaire will encompass inquiries regarding demographics patient characteristics treatment-related positive and negative factors improvement of care and patient satisfaction
Two groups will complete the questionnaires one group that viewed an educational video before Novasure treatment and a control group that did not view the video Both groups receive the same treatment Novasure with the only difference being the addition of the educational video as part of pre-procedural preparation as both groups receive information from the gynecologist about the procedure Additionally patients have access to further information online or in brochures Therefore conducting this study raises no ethical concerns
The researchers conducted a power calculation using GPower 3 to determine the sample size for the questionnaire research Based on this calculation considering a pilot study and prior research suggesting a minimum of 12 patients per group the aim was to include 16 patients per group total 32 patients
Data will be analyzed by an intention-to-treat analysis Frequencies and percentages for general characteristics will be determined The mean plus standard deviation of VAS-A APAIS anxiety and need to obtain information scores and other scale variables will be calculated Mann-Whitney U tests will be used to assess group differences for VAS-A APAIS and scale variables A p005 will be considered statistically significant Descriptive statistics will be used to compute frequencies and corresponding percentages for nominal and ordinal variables
Subjects will be recruited from the outpatient clinic from Máxima Medical Center Eindhoven and Veldhoven Patients presenting with heavy menstrual bleeding and scheduled for endometrial ablation Novasure between March 2022 and April 2024 were approached for study participation either by email phone call or in-person during their clinic visit Upon expressing interest patients will be provided with detailed information about the study and asked to sign an informed consent form Patients were randomized in an alternating order and 11 ratio
Subsequently after randomization the participants will be sent a secure email containing the link to the educational videos Patients will watch the educational videos 1-7 days before their Novasure treatmentOn the day of treatment before undergoing the Novasure procedure patients will complete the Visual Analogue Scale for Anxiety VAS-A and Amsterdam Preoperative Anxiety and Information Scale APAIS
Two days post-treatment the participants will receive a questionnaire via email through Research Manager This questionnaire will encompass inquiries regarding demographics patient characteristics treatment-related positive and negative factors improvement of care and patient satisfaction
Two groups will complete the questionnaires one group that viewed an educational video before Novasure treatment and a control group that did not view the video Both groups receive the same treatment Novasure with the only difference being the addition of the educational video as part of pre-procedural preparation as both groups receive information from the gynecologist about the procedure Additionally patients have access to further information online or in brochures Therefore conducting this study raises no ethical concerns
The researchers conducted a power calculation using GPower 3 to determine the sample size for the questionnaire research Based on this calculation considering a pilot study and prior research suggesting a minimum of 12 patients per group the aim was to include 16 patients per group total 32 patients
Data will be analyzed by an intention-to-treat analysis Frequencies and percentages for general characteristics will be determined The mean plus standard deviation of VAS-A APAIS anxiety and need to obtain information scores and other scale variables will be calculated Mann-Whitney U tests will be used to assess group differences for VAS-A APAIS and scale variables A p005 will be considered statistically significant Descriptive statistics will be used to compute frequencies and corresponding percentages for nominal and ordinal variables
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None