The Effect of Virtual Reality on Psychological Parameters in Patients Receiving Chemotherapy

NCT05475509 | Completed DMC

• 1 other identifier: vesile25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

It has been determined that after mastectomy, women have psychological problems such as deterioration of body image, fear of losing their feminine characteristics and sexual dysfunction. Chemotherapy treatment for the first time causes patients to feel hopeless, to experience uncertainty and anxiety, and to increase their stress level. Experiencing intense stress during this treatment process can lead to severe mental problems, which negatively affects the course of the disease and the response to treatment. Chemotherapy is a painful procedure. Pain and stress are symptoms that affect each other positively. Virtual reality glasses, which is one of the distraction methods used in the control of symptoms; It is widely used in clinical medical care to relieve symptoms by offering the possibility to create therapeutic environments in the evaluation and treatment of medical conditions. By affecting the emotional, cognitive, behavioral and sociocultural dimensions of the individual, it increases the sense of control, activity level and work capacity, reduces stress, pain, anxiety level, feeling of powerlessness and side effects of pharmacological methods.

Conditions

Side Effect of Chemotherapy

Keywords

anxiety; pain; tension; oxygen saturation

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale (VAS):

  VAS; It consists of a 10 cm long line starting with absence of pain (0) and ending with excruciating pain (10). The patient marks the severity of his pain on this line where he sees fit, this scale aims to explain the patient's pain in numbers.

  up to 24 hours

• Determination of Cortisol Level in Saliva:

  The UPLC-MS/MS system will be used for the determination of cortisol in saliva. A reverse phase C18 column will be used for the determination of cortisol. A mixture of 5 mM ammonium acetate and methanol (25: 75, v/v) will be used as the mobile phase. The flow rate will be determined as 0.25 ml/min. The injection volume will be 5 µL and the column oven temperature will be 25 °C. In analyzes performed in MRM mode, 363.2→121.1 ions will be selected.

  up to 24 hours

• State-Trait Anxiety Inventory (STAI I-II):

  The State-Trait Anxiety Inventory measures anxiety in adolescents over the age of 14 and adults. The scale, which is a type of self-assessment, includes 40 items consisting of short statements. 1-20 on the scale. questions, the state anxiety level of the individual, 21-40. The questions determine the level of trait anxiety. The total point value obtained from the inventory can vary between 20 and 80. A high score indicates a high level of anxiety, while a small score indicates a low level of anxiety.

  up to 24 hours

• Application Registration Form:

  Pulse and oxygen saturation measurements of the patients before and after chemotherapy will be recorded in this form.

  Investigators evaluate the change before and after chemotherapy in the 24-hour time frame.

Study Arms (2)

virtual reality group (nature videos were watched by wearing virtual reality glasses)

EXPERIMENTAL

In the experimental group, saliva sample will be taken before chemotherapy, Personal Information Form, State Anxiety Scale and VAS pre-test questionnaires will be applied, pre-test questionnaires will be applied to measure vital signs, and then virtual reality glasses will be introduced to the patients and the duration will vary between 3-10 minutes for a total of 30 minutes. A saliva sample will be taken and a post-test will be applied, with virtual reality glasses, videos with music background, park, nature and seaside walks, underwater, museum trips, videos that the patient wants to watch and can change whenever they want. Each patient will be shown the same video.

Other: Virtually reality

Control Group

NO INTERVENTION

Personal Information Form, State Anxiety Scale and VAS pre-test questionnaires will be applied to the patients who accepted to participate in the study, saliva sample will be taken from the control group before chemotherapy, vital signs measurements will be made and post-test questionnaires will be applied at the 30th minute of chemotherapy, vital signs measurements will be made and saliva sample will be taken.

Interventions

Virtually reality OTHER

Before chemotherapy, saliva samples will be taken from the control group, Personal Information Form, State Anxiety Scale and Visual Analogue Scale (VAS) pre-test questionnaires will be applied to the patients who accepted to participate in the study, vital signs measurements will be made and post-test questionnaires will be applied at the 30th minute of chemotherapy, vital signs measurements will be made, and A saliva sample will be taken. In the experimental group, a saliva sample will be taken before chemotherapy.

Also known as: experimental-control group

virtual reality group (nature videos were watched by wearing virtual reality glasses)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: The female gender was chosen because breast cancer is mostly seen in women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients who have had a mastectomy and will receive the first cure of outpatient chemotherapy
• Those between the ages of 18-75
• Willingness to participate in the research
• Absence of mental and communication problems
• No vision or hearing perception problem

You may not qualify if:

• Patients who stopped participating in the study
• Patients with mental and communication problems

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University

Erzurum, Palandöken, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vesile Eskici İlgin, PhD

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The research will be carried out by applying an experimental research design with a control group, pre-test-post-test applied, repetitive measurement.

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 27, 2022
• Study Start: May 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: July 30, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

TU (1)