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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-03-28

Brief Summary

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Aim: The goal of this randomized controlled trial is to detect the effect of using multimedia during the informed consent process on the anxiety of parents of orchiopexy patients.

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?

Detailed Description

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Aim: The goal of this randomized controlled trial is to detect the effect of using multimedia during the informed consent process on the anxiety of parents of orchiopexy patients.

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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Undescended Testis Anxiety State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type NO_INTERVENTION

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.

Group Type ACTIVE_COMPARATOR

Video Multimedia

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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Multimedia Group

Eligibility Criteria

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Inclusion Criteria

* parents of orchiopexy patients

Exclusion Criteria

* history of previous orchiopexy surgery
* orchiopexy with other surgical procedures ( f.e. Hypospadias repair)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mehmet Çetin

Role: CONTACT

+905366961923

Facility Contacts

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Mehmet Çetin

Role: primary

+905366961923

Other Identifiers

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MAR.UAD.009

Identifier Type: -

Identifier Source: org_study_id

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