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

Not Applicable

Recruiting

• Conditions: Undescended Testis; Anxiety State

• Registration Number: NCT06698081
• Lead Sponsor: Marmara University

Brief 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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study Start: 2024-11-20
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-03-25
• Study Completion: 2025-03-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• parents of orchiopexy patients

Exclusion Criteria

• history of previous orchiopexy surgery
• orchiopexy with other surgical procedures ( f.e. Hypospadias repair)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Beck Anxiety Inventory	1 week	The participants' BECK anxiety scores will be noted one day before the surgery and on the 7th day after the surgery.
State-Trait Anxiety Inventory (STAI)	1 week	The participants' STAI - Tx I and STAI -Tx II scores will be noted one day before and on the 7th day after the surgery.
Hospital Anxiety and Depression Scale (HADS)	1 week	The participants' HADS scores will be noted one day before the surgery and on the 7th day after the surgery.

Trial Locations

Locations (1)

Marmara University School of Medicine, Department of Urology; 🇹🇷 Istanbul, Turkey