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

NCT06698081 | Recruiting

• 1 other identifier: MAR.UAD.009
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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?

Conditions

Undescended Testis; Anxiety State

Keywords

undescended testis; anxiety state

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Standard Informed Consent Form + Verbal Information

NO INTERVENTION

The first group will be informed of the Standard Informed Consent Form and Verbal Information during the preoperative process.

Standard Informed Consent Form + Verbal Information + Multimedia

ACTIVE COMPARATOR

The second group will be informed of the Standard Informed Consent Form, Verbal Information, and Multimedia.

Other: Video Multimedia

Interventions

Video Multimedia 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.

Also known as: Multimedia Group

Standard Informed Consent Form + Verbal Information + Multimedia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• parents of orchiopexy patients

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine, Department of Urology

Istanbul, Istanbul, 34890, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cryptorchidism; Anxiety Disorders

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Mental Disorders

Study Officials

• Cagri Akin Sekerci

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Mehmet Çetin

CONTACT

+905366961923; m.cetin_47@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 20, 2024
• Study Start: November 20, 2024
• Primary Completion: March 25, 2025
• Study Completion: March 28, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)