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

Marmara University

Status: Enrolling

Conditions: Undescended Testis; Anxiety State

Treatments: Other: Video Multimedia

Study type: Interventional

Funder types: Other

Identifiers

NCT06698081

MAR.UAD.009

Details and patient eligibility

About

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?

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• parents of orchiopexy patients

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Standard Informed Consent Form + Verbal Information

No Intervention group

Description:

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 group

Description:

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

Treatment:

Other: Video Multimedia