Anxiety Scores With Media Based Patient Education Before Dilatation and Curettage

NCT ID: NCT03930303

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-23
• Study Completion Date: 2019-11-15

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.

Conditions

Abnormal Uterine Bleeding; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Multimedia Arm

Group Type: ACTIVE_COMPARATOR

Multimedia- based patient education

Intervention Type: BEHAVIORAL

Patients will receive a 5 minutes video education before D\&C

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multimedia- based patient education

Patients will receive a 5 minutes video education before D\&C

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gulseren Yilmaz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huseyin Kiyak, MD

Role: STUDY_CHAIR

Kanuni Sultan Suleyman Hospital

Locations

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Gulseren1

Identifier Type: -

Identifier Source: org_study_id