NCT03930303

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 23, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

April 24, 2019

Last Update Submit

November 20, 2019

Conditions

Keywords

dilatation and curettagemultimedia based educationanxiety

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Multimedia Arm

ACTIVE COMPARATOR
Behavioral: Multimedia- based patient education

Control

NO INTERVENTION

Interventions

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

Multimedia Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Psychological disease Contraindication for hysteroscopy Visual deficit, Auditory deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, 34005, Turkey (Türkiye)

Location

MeSH Terms

Conditions

MetrorrhagiaAnxiety DisordersDilatation, Pathologic

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersPathological Conditions, Anatomical

Study Officials

  • Huseyin Kiyak, MD

    Kanuni Sultan Suleyman Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 29, 2019

Study Start

August 23, 2019

Primary Completion

November 5, 2019

Study Completion

November 15, 2019

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations