Brief Title- Virtual Reality Glasses in Gynecologic Cancer

NCT06760689 | Enrolling By Invitation

• 1 other identifier: CAKU-HEM-BO-01
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancers; Anxiety

Keywords

Anxiety; chemotherapy; Gynecological cancer; Virtual reality; Adherence to treatment; rastgele kontrollü deneme

Outcome Measures

Primary Outcomes (3)

• Effect of Virtual Reality Glasses on Treatment Adherence and Anxiety Levels in Gynecological Cancer Patients Receiving Chemotherapy.

  59 experimental groups of female patients in the outpatient chemotherapy unit will be shown a video of their choice, such as nature, underwater, or forest walk, placed in virtual reality glasses, taking into account the inclusion and exclusion criteria. Questions on two scales will be asked before and after this viewing. For the control group of 59 people, the same questions on two scales will be asked before and after chemotherapy without any intervention.

  20 weeks

• State and trait anxiety scale

  This scale consists of two sub-dimensions, each consisting of 20 items, and contains a total of 40 items. The sub-scales are called "State Anxiety Scale" and "Trait Anxiety Scale". The first 20 items evaluate the emotional experiences of the individual in a certain situation. The emotions of the participants are expressed with the specific features of (1) None, (2) A Little, (3) A Lot, and (4) Completely. The items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 in the State Anxiety Scale consist of translated expressions. These scores are translated in return (1=4, 2=3, 3=2, 4=1). Others represent correct objects. The state anxiety score varies between 20 and 80 in total, and reflects personal anxiety rates. High scores indicate high anxiety levels, and low scores indicate low anxiety levels.

  20 weeks

• Chronic Disease Adjustment Scale

  It is a scale used to evaluate the adaptation level of patients with chronic diseases. This scale, which consists of three subdimensions and 25 items, measures physical adaptation with items 1, 9, 10, 13, 14, 15, 16, 18, 22, 23, and 24 (maximum 55, minimum 11 points), social adaptation with items 2, 3, 5, 7, 17, 19, and 25 (maximum 35, minimum 7 points) and psychological adaptation with items 4, 6, 8, 11, 12, 20, and 21 (maximum 35, minimum 7 points). The total score obtained from the scale is 125. High scores obtained from the subdimensions or the entire scale indicate that the patients' adaptation level to the disease is high.

  20 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Device: virtual reality glasses; Other: scale

control group

ACTIVE COMPARATOR

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.

Other: scale

Interventions

virtual reality glasses DEVICE

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

Experimental group

scale OTHER

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

Experimental group; control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Individuals who have been diagnosed with gynecological cancer at the relevant institution, who will start their first course of chemotherapy, who have stage 1-2-3 cancer, who volunteer for the research, who are 18 years of age or older, and who are literate will be included.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

Etlik Şehir Hastanesi

Ankara, Yenimahalle, 06600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Treatment Adherence and Compliance

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It will be done bilaterally to determine whether there is a difference between the experimental and control groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: The study has a single-center, randomized controlled experimental design. It includes the experimental and control group.

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 7, 2025
• Study Start: December 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: July 31, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)