Brief Title- Virtual Reality Glasses in Gynecologic Cancer

NCT ID: NCT06760689

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-07-31

Brief Summary

It was planned to determine the effect of virtual reality glasses used in female patients diagnosed with gynecological cancer and receiving chemotherapy on treatment compliance and anxiety level. The study has a single-center, randomized controlled experimental design.

Detailed Description

When cancer is diagnosed, a process of uncertainty begins for the individual. When an individual associates their illness with death, they often consider the situation to be frightening, painful, complex, and ambiguous, which can lead to mental confusion. ). In these emotional fluctuations, studies have revealed that a large proportion of patients experience various mental problems such as anxiety and anxiety disorders, coordination disorders and adherence to treatment, both due to the burden of the disease and the side effects of treatment. Emotional negativities felt by the patient may cause the recovery process to be prolonged, the quality of life to decrease, and the length of hospital stay to increase when in a hospital environment. In order to prevent such negativities, it is very important to identify the symptoms of anxiety and depression in cancer patients at an early stage and to initiate appropriate treatments. The development and application of the latest technology in the field of health offers new and non-invasive approaches to cancer-related symptom management. Virtual reality (SG), a new era in the management of symptoms, is the combination of fiction, imagination and reality, which is capable of real reflective animation at the same time under the control of many devices. Virtual reality (SG), a new era in the management of symptoms, is the combination of fiction, imagination and reality, which is capable of real reflective animation at the same time under the control of many devices.In a clinical study, it was concluded that distracting videos (tennis, boxing video, etc.) watched with virtual reality glasses had a beneficial therapeutic effect on edema.As a result of the one-week virtual reality application awareness training conducted on 50 women with ovarian cancer who experienced anxiety, depression and cancer-related fatigue during chemotherapy in Beijing, China, it was recorded that these symptoms improved significantly.When the literature was reviewed, it was predicted that the application of virtual reality glasses in cancer patients in our country was limited, and this study was planned to determine the effect of virtual reality glasses used in female patients diagnosed with gynecological cancer and receiving chemotherapy on the level of compliance and anxiety.

Conditions

Gynecologic Cancers; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental group

The patient was given detailed information about the research and intervention, and written consent was obtained with an informed voluntary consent form. The patient's information was obtained through the descriptive information form containing sociodemographic information.The same ways were applied for 1,2,3 cures. The researcher applied the pre-test State and Trait Anxiety Scale, and the Chronic Disease Adaptation Scale (CHSS) to the patient.The patient was directed to move to the room designated by the nurse in the outpatient unit. Before the chemotherapy course began, the patient was shown the content that the patient could watch through virtual reality glasses on the phone.He was asked to choose one of them.The patient watched a video of his/her choice with the virtual reality glasses application (20 min). At the end, the glasses were removed. Afterwards, the State and Trait Anxiety Scale and the Chronic Diseases Adjustment Scale (CHAS) were applied.

Group Type: EXPERIMENTAL

virtual reality glasses

Intervention Type: DEVICE

One of the videos chosen by the patient will be opened in the virtual reality glasses and will be played for 20 minutes.

scale

Intervention Type: OTHER

The patient received standard nursing care. Scales were filled in after the course.

control group

The pre-test State and Trait Anxiety Scale and Chronic Disease Adjustment Scale (CHAS) were applied to the patient by the researcher.

The patient was directed to the room determined by the nurse in the outpatient treatment unit.

The patient's chemotherapy infusion started.The patient received standard nursing care. After 30 minutes, the State and Trait Anxiety Scale and the Chronic Diseases Adjustment Scale (CHAS) were administered.

Group Type: ACTIVE_COMPARATOR

scale

Intervention Type: OTHER

The patient received standard nursing care. Scales were filled in after the course.

Interventions

virtual reality glasses

One of the videos chosen by the patient will be opened in the virtual reality glasses and will be played for 20 minutes.

Intervention Type: DEVICE

scale

The patient received standard nursing care. Scales were filled in after the course.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being over 18 years old.
• Stage 1-2-3
• Knowing the disease diagnosis
• Knowing how to read and write in Turkish
• No history of seizures
• No cranial metastasis
• Not diagnosed with a psychiatric disorder, no dementia
• Those who receive their treatment in 21-day periods to ensure equality in application frequencies
• Able to use virtual reality glasses
• No visual or hearing impairment
• Volunteer patients

Exclusion Criteria

• Stage 4
• Those with vertigo
• Those with hyperemesis during pregnancy
• Those who experience nausea and vomiting during travel
• Those with visual and hearing impairment
• Patients who do not know their cancer diagnosis, have been diagnosed with cancer but have not received treatment or have completed their cure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Çankırı Karatekin University

OTHER

Sponsor Role: lead

Responsible Party

Beyza Önder

Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Etlik Şehir Hastanesi

Ankara, Yenimahalle, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CAKU-HEM-BO-01

Identifier Type: -

Identifier Source: org_study_id