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

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?

Study Overview

• Status: Recruiting
• Conditions: Anxiety State; Undescended Testis
• Intervention / Treatment: Other: Video Multimedia

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mehmet Çetin; Phone Number: +905366961923; Email: m.cetin_47@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34890
    • Recruiting
    • Marmara University School of Medicine, Department of Urology
    • Contact: Mehmet Çetin; Phone Number: +905366961923; Email: m.cetin_47@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• parents of orchiopexy patients

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: Standard Informed Consent Form + Verbal Information + Multimedia; The second group will be informed of the Standard Informed Consent Form, Verbal Information, and Multimedia.	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.; Other Names: Multimedia Group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Director: Cagri Akin Sekerci, Marmara University

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2024
• Primary Completion (Estimated): March 25, 2025
• Study Completion (Estimated): March 28, 2025

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Estimated): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: anxiety state; undescended testis
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Gonadal Disorders; Congenital Abnormalities; Urogenital Abnormalities; Testicular Diseases; Anxiety Disorders; Cryptorchidism
• Other Study ID Numbers: MAR.UAD.009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No