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NCT Number: NCT06698081

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

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?

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Key information

Conditions

Undescended Testis Anxiety Disorders Anxiety State Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cryptorchidism Endocrine System Diseases Genital Diseases Genital Diseases, Male Gonadal Disorders Male Urogenital Diseases Mental Disorders Testicular Diseases Urogenital Abnormalities Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University School of Medicine, Department of Urology

Istanbul, 34890, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mehmet Çetin

CONTACT

[email protected]

+905366961923

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • parents of orchiopexy patients

Exclusion criteria

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

Treatment and study plan

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.

Other names: Multimedia Group

Primary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 1 week

    The participants' HADS scores will be noted one day before the surgery and on the 7th day after the surgery.

  2. Beck Anxiety Inventory

    Time frame: 1 week

    The participants' BECK anxiety scores will be noted one day before the surgery and on the 7th day after the surgery.

  3. State-Trait Anxiety Inventory (STAI)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet Çetin

CONTACT

[email protected]

+905366961923

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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