Abnormal Uterine BleedingNCT06397898
NOVasure EXpierences (NOVEX)
A study testing Educational video in people with Abnormal Uterine Bleeding, run by Maxima Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding
- What is being tested?
- Educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NOVasure Endometrial Ablation Pre-, Peri- and Postprocedural Patient's EXperiences and Satisfaction for Women With Heavy Menstrual Bleeding (the NOVEX Trial): A Qualitative Questionnaire Pilot-study
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.
Read more
In this randomized-controlled pilot study, the aim is :
- To determine if educational videos that show experiences from women with HMB that were treated with Novasure endometrial ablation affect preoperative anxiety.
- To assess if educational videos have an effect on preoperative need for information
- To explore Novasure pre-, peri- and postoperative patient experiences
- To define positive and negative factors related to Novasure endometrial ablation
- To gain insight in factors that could improve patient satisfaction before, during and after Novasure endometrial ablation and to evaluate the educational videos.
Read the 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 1:1 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 treatment.On 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 G*Power 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 p<0.05 will be considered statistically significant. Descriptive statistics will be used to compute frequencies and corresponding percentages for nominal and ordinal variables.
- Conditions
- Abnormal Uterine Bleeding
- Being tested
- Educational video
- Keywords
- endometrial ablation
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
Viewing an educational video before Novasure treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (video) | Experimental | group that viewed an educational video before Novasure treatment Receives: Other: Educational video |
| Control group (no video) | No intervention | group that did not view an educational video before Novasure treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) . Anxiety scores are calculated by adding up the scores of questions 1, 2, 4, and 5. Patients with an anxiety score of ≥11 are considered anxious. Information need scores are calculated by adding up the scores of question 3 and 6. A score between 2-4 represents no to little need to obtain information, a score between 5-7 represents an average need to obtain information, and a score between 8-10 represents a high need to obtain information about the procedure and anesthesia.
Measured: 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.
Patients will fill in an online questionnaire, including questions about demographics, patient characteristics, treatment-related positive and negative factors, improvement of care, and patient satisfaction.
Measured: two days after post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Mar 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized-controlled pilot study
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Dkhissi, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397898
- Sponsor's protocol ID
- N21.091
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOVasure Endometrial Ablation Pre-, Peri- and Postprocedural Patient's EXperiences and Satisfaction for Women With Heavy Menstrual Bleeding (the NOVEX Trial): A Qualitative Questionnaire Pilot-study
- ClinicalTrials.gov ID
- NCT06397898
- Acronym / sponsor ID
- N21.091
- Conditions
- Abnormal Uterine Bleeding
- Keywords
- endometrial ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- To determine if educational videos that show experiences from women with HMB that were treated with Novasure endometrial ablation affect preoperative anxiety.
- To assess if educational videos have an effect on preoperative need for information
- To explore Novasure pre-, peri- and postoperative patient experiences
- To define positive and negative factors related to Novasure endometrial ablation
- 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 1:1 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 treatment.On 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 G*Power 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 p<0.05 will be considered statistically significant. Descriptive statistics will be used to compute frequencies and corresponding percentages for nominal and ordinal variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized-controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| Intervention group (video) | Experimental | Other: Educational videogroup that viewed an educational video before Novasure treatment |
| Control group (no video) | No intervention | –group that did not view an educational video before Novasure treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videoViewing an educational video before Novasure treatment | Other | Intervention group (video) |
Primary outcome
Preoperative anxiety
Time frame: Patients fill out the VAS-A form in the hospital shortly before the procedure.
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.
2 secondary outcomes
Preoperative anxiety and the need to obtain information about the procedure and anesthesia.
Time frame: 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.
Time frame: two days after post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Abnormal Uterine Bleeding, run by Maxima Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative anxiety (time frame: Patients fill out the VAS-A form in the hospital shortly before the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.