Back to resultsAnxiety Scores With Media Based Patient Education Before Dilatation and Curettage
Primary Purpose
Abnormal Uterine Bleeding, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Multimedia- based patient education
Sponsored by
About this trial
This is an interventional prevention trial for Abnormal Uterine Bleeding focused on measuring dilatation and curettage, multimedia based education, anxiety
Eligibility 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
Sites / Locations
- Kanuni Sultan Suleyman Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Multimedia Arm
Control
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03930303
First Posted
April 24, 2019
Last Updated
November 20, 2019
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03930303
Brief Title
Anxiety Scores With Media Based Patient Education Before Dilatation and Curettage
Official Title
Impact of Media-based Patient Education on Anxiety Scores in Patients Undergoing Dilatation and Curettage at Office Setting
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 23, 2019 (Actual)
Primary Completion Date
November 5, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Uterine Bleeding, Anxiety
Keywords
dilatation and curettage, multimedia based education, anxiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multimedia Arm
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Multimedia- based patient education
Intervention Description
Patients will receive a 5 minutes video education before D&C
Primary Outcome Measure Information:
Title
Change in State-Trait Anxiety Inventory score from baseline to watching video or verbal information
Description
Total score for both State anxiety inventory and Trait anxiety score (Range: 20 to 80 points, higher values represent a worse outcome)
Time Frame
30 minutes before and 10 minutes after multimedia education/verbal information
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huseyin Kiyak, MD
Organizational Affiliation
Kanuni Sultan Suleyman Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
State/Province
Please Enter The State Or Province
ZIP/Postal Code
34005
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Anxiety Scores With Media Based Patient Education Before Dilatation and Curettage
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