NCT06698081

The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients

The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Marmara University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Undescended Testis
• Anxiety State

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-11-20
• Primary completion: 2025-03-25
• Completion: 2025-03-28
• First posted: 2024-11-20
• Last updated: 2024-11-20

Locations

1 site across 1 country: Turkey (Türkiye)