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Anxiety Scores With Media Based Patient Education Before Dilatation and Curettage

  • Clinicaltrials.gov identifier

    NCT03930303

  • Recruitment Status

    Completed

  • First Posted

    April 29, 2019

  • Last update posted

    November 21, 2019

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.

  • Condition or Disease:Abnormal Uterine Bleeding
    Anxiety
  • Intervention/Treatment: Behavioral: Multimedia- based patient education
  • Phase: N/A

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.

Study Design

  • Study Type: Interventional
  • Actual 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 2019
  • Actual Primary Completion Date: November 2019
  • Actual Study Completion Date: November 2019

Arms and interventions

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

Outcome Measures

  • 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)

Eligibility Criteria

  • Ages Eligible for Study: 18 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

Contacts and Locations

Contacts

Locations

Turkey, Please Enter The State Or Province
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul

Sponsors and Collaborators

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

Study Chair: Huseyin Kiyak, MD Kanuni Sultan Suleyman Hospital

More Information

  • Responsible Party: 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: November 21, 2019
  • Last Verified: November 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Kanuni Sultan Suleyman Training and Research Hospital: dilatation and curettage
    multimedia based education
    anxiety
  • Additional relevant MeSH terms: Aneurysm
    Dilatation, Pathologic
    Anxiety Disorders
    Uterine Hemorrhage