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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03930303
Other study ID # Gulseren1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 23, 2019
Est. completion date November 15, 2019

Study information

Verified date November 2019
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date November 15, 2019
Est. primary completion date November 5, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Multimedia- based patient education
Patients will receive a 5 minutes video education before D&C

Locations

Country Name City State
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul Please Enter The State Or Province

Sponsors (1)

Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 30 minutes before and 10 minutes after multimedia education/verbal information
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