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Anxiety Scores With Media Based Patient Education Before Dilatation and Curettage

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ClinicalTrials.gov Identifier: NCT03930303
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Gulseren Yilmaz, Kanuni Sultan Suleyman Training and Research Hospital

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Abnormal Uterine Bleeding Anxiety Behavioral: Multimedia- based patient education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Media-based Patient Education on Anxiety Scores in Patients Undergoing Dilatation and Curettage at Office Setting
Actual Study Start Date : August 23, 2019
Actual Primary Completion Date : October 2, 2019
Estimated Study Completion Date : October 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Anxiety

Arm Intervention/treatment
Active Comparator: Multimedia Arm Behavioral: Multimedia- based patient education
Patients will receive a 5 minutes video education before D&C

No Intervention: Control



Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinical diagnosis of abnormal uterine bleeding Scheduled for dilatation and curettage Must understand the characteristics of the study

Exclusion Criteria:

Psychological disease Contraindication for hysteroscopy Visual deficit, Auditory deficit


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930303


Contacts
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Contact: Gulseren Yilmaz, MD +902124041500 drgulseren83@gmail.com

Locations
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Turkey
Kanuni Sultan Suleyman Training and Research Hospital Recruiting
Istanbul, Please Enter The State Or Province, Turkey, 34005
Contact: Gulseren Yilmaz, M.D.    2124041500    drgulseren83@gmail.com   
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
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Study Chair: Huseyin Kiyak, MD Kanuni Sultan Suleyman Hospital

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Responsible Party: Gulseren Yilmaz, Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03930303     History of Changes
Other Study ID Numbers: Gulseren1
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gulseren Yilmaz, Kanuni Sultan Suleyman Training and Research Hospital:
dilatation and curettage
multimedia based education
anxiety
Additional relevant MeSH terms:
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Uterine Hemorrhage
Aneurysm
Dilatation, Pathologic
Anxiety Disorders
Mental Disorders
Hemorrhage
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female