The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients
NCT ID: NCT06698081
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-11-20
2025-03-28
Brief Summary
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Parents (primary caregivers) of the patients who underwent orchiopexy surgery are included in the study.
The main question it aims to answer is:
• Does the use of multimedia during the preoperative consent process affect the anxiety level of parents of patients undergoing orchiopexy surgery?
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Detailed Description
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Parents (primary caregivers) of the patients who underwent orchiopexy surgery are included in the study.
The patient's age, gender, known diseases, previous hospital admissions, and whether they have undergone surgery before will be recorded. The primary caregiver's age, gender, known diseases, educational status, occupation, number of children, and any additional illnesses in other children will be noted.
Patients will be randomized into 2 groups with the help of (https://www.randomizer.org/ ). The first group will be informed of the Standard Consent Form and Verbal Information during the preoperative process. In contrast, the second group will be informed of the Standard Consent Form, Verbal Information, and Multimedia. Both groups will fill out the Hospital Anxiety and Depression Scale(HADS), BECK Anxiety Inventory(BAI), and The State-Trait Anxiety Inventory (STAI) Form Tx 1-2 forms one day before the surgery and on the 7th day after the surgery to determine their anxiety levels.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard Informed Consent Form + Verbal Information
The first group will be informed of the Standard Informed Consent Form and Verbal Information during the preoperative process.
No interventions assigned to this group
Standard Informed Consent Form + Verbal Information + Multimedia
The second group will be informed of the Standard Informed Consent Form, Verbal Information, and Multimedia.
Video Multimedia
The second group will be informed of the Standard Informed Consent Form, Verbal Information, and Multimedia. In addition to the standard consent process, we planned to show a 6-minute video multimedia presentation containing information about undescended testis and orchiopexy.
Interventions
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Video Multimedia
The second group will be informed of the Standard Informed Consent Form, Verbal Information, and Multimedia. In addition to the standard consent process, we planned to show a 6-minute video multimedia presentation containing information about undescended testis and orchiopexy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* orchiopexy with other surgical procedures ( f.e. Hypospadias repair)
18 Years
ALL
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Principal Investigators
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Cagri Akin Sekerci
Role: STUDY_DIRECTOR
Marmara University
Locations
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Marmara University School of Medicine, Department of Urology
Istanbul, Istanbul, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MAR.UAD.009
Identifier Type: -
Identifier Source: org_study_id
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