Abnormal Uterine BleedingNCT03930303
Anxiety Scores With Media Based Patient Education Before Dilatation and Curettage
A study testing Multimedia- based patient education in people with Abnormal Uterine Bleeding and Anxiety, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Subjects with abnormal uterine bleeding and scheduled for dilatation and curettage (D\&C) will be randomized to a multimedia-based education (MME group) or verbal information (Control group ) before (D\&C). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding, Anxiety
- What is being tested?
- Multimedia- based patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Aug 2019to 15 Nov 2019
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of abnormal uterine bleeding Scheduled for dilatation and curettage Must understand the characteristics of the study
Who cannot join
- Psychological disease Contraindication for hysteroscopy Visual deficit, Auditory deficit
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Please Enter the State Or Province, 34005
About this study
Official title: Impact of Media-based Patient Education on Anxiety Scores in Patients Undergoing Dilatation and Curettage at Office Setting
Subjects with abnormal uterine bleeding and scheduled for dilatation and curettage (D\&C) will be randomized to a multimedia-based education (MME group) or verbal information (Control group ) before (D\&C). State-Trait Anxiety Inventory will be asked by the nursing staff before and after multimedia-based education or verbal information to all patients. Then the patients will undergo (D\&C) at an office setting. The impact of MME on patient anxiety will be evaluated by statistical analysis.
Read the detailed description
Subjects with abnormal uterine bleeding and scheduled for dilatation and curettage (D\&C) with diagnostic or treatment purpose will be randomized to two intervention arms. Multimedia-education Group (MME group) and verbal information group (Control Group). Both groups will receive State-Trait Anxiety Inventory before and after education and then will undergo D\&C at an office setting. State-Trait Anxiety Inventory will be asked by the nursing staff. Multimedia-based education will be carried out using a 5 minutes video explaining the details of D\&C. D\&C will be carried out at office setting by an experienced gynecologist under sedation and analgesia.
- Conditions
- Abnormal Uterine Bleeding, Anxiety
- Being tested
- Multimedia- based patient education
- Keywords
- dilatation and curettage, multimedia based education, anxiety
- Medical subject headings
- Metrorrhagia, Anxiety Disorders, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia- based patient educationBehavioural
Patients will receive a 5 minutes video education before D\&C
| Study group | Role | What they receive |
|---|---|---|
| Multimedia Arm | Active comparator | Not described Receives: Behavioral: Multimedia- based patient education |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State-Trait Anxiety Inventory score from baseline to watching video or verbal information
Total score for both State anxiety inventory and Trait anxiety score (Range: 20 to 80 points, higher values represent a worse outcome)
Measured: 30 minutes before and 10 minutes after multimedia education/verbal information
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start23 Aug 2019
- Primary completion5 Nov 2019
- Study completion15 Nov 2019
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulseren Yilmaz, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Huseyin Kiyak, MD, Study chair, Kanuni Sultan Suleyman Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930303
- Sponsor's protocol ID
- Gulseren1
- Status last verified
- Nov 2019
- First submitted
- 24 Apr 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Media-based Patient Education on Anxiety Scores in Patients Undergoing Dilatation and Curettage at Office Setting
- ClinicalTrials.gov ID
- NCT03930303
- Acronym / sponsor ID
- Gulseren1
- Conditions
- Abnormal Uterine Bleeding, Anxiety
- Keywords
- dilatation and curettage, multimedia based education, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 29 Apr 2019 (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.
Subjects with abnormal uterine bleeding and scheduled for dilatation and curettage (D\&C) will be randomized to a multimedia-based education (MME group) or verbal information (Control group ) before (D\&C). State-Trait Anxiety Inventory will be asked by the nursing staff before and after multimedia-based education or verbal information to all patients. Then the patients will undergo (D\&C) at an office setting. The impact of MME on patient anxiety will be evaluated by statistical analysis.
Detailed description
Subjects with abnormal uterine bleeding and scheduled for dilatation and curettage (D\&C) with diagnostic or treatment purpose will be randomized to two intervention arms. Multimedia-education Group (MME group) and verbal information group (Control Group). Both groups will receive State-Trait Anxiety Inventory before and after education and then will undergo D\&C at an office setting. State-Trait Anxiety Inventory will be asked by the nursing staff. Multimedia-based education will be carried out using a 5 minutes video explaining the details of D\&C. D\&C will be carried out at office setting by an experienced gynecologist under sedation and analgesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimedia Arm | Active comparator | Behavioral: Multimedia- based patient education |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of abnormal uterine bleeding Scheduled for dilatation and curettage Must understand the characteristics of the study
Key exclusion criteria (1 listed)
- Psychological disease Contraindication for hysteroscopy Visual deficit, Auditory deficit
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 |
|---|---|---|
| Multimedia- based patient educationPatients will receive a 5 minutes video education before D\&C | Behavioural | Multimedia Arm |
Primary outcome
Change in State-Trait Anxiety Inventory score from baseline to watching video or verbal information
Time frame: 30 minutes before and 10 minutes after multimedia education/verbal information
Total score for both State anxiety inventory and Trait anxiety score (Range: 20 to 80 points, higher values represent a worse outcome)
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 21 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Huseyin Kiyak, MD study chair
Kanuni Sultan Suleyman Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimedia- based patient education in people with Abnormal Uterine Bleeding and Anxiety, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 21 Nov 2019. 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 Turkey (Türkiye). 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?
Change in State-Trait Anxiety Inventory score from baseline to watching video or verbal information (time frame: 30 minutes before and 10 minutes after multimedia education/verbal information). 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 21 Nov 2019.