The Effect Of Virtual Reality Glasses On Vital Signs And State Anxiety Level In Cancer Patients

May 30, 2023 updated by: Bahar İNKAYA

The Effect Of Virtual Reality Glasses On Vital Signs And State Anxiety Level In Cancer Patients Receiving Chemotherapy For The First Time- Randomized Control Trial

This study was conducted as a non-randomized control group experimental study to determine the effect of virtual reality glasses on vital signs and state anxiety levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose This study was conducted as a non-randomized control group experimental study to determine the effect of virtual reality glasses on vital signs and state anxiety levels in cancer patients receiving chemotherapy for the first time.

Methods and Sample The population of the study was composed of adult patients admitted to an oncology hospital in Ankara province with a diagnosis of stage I-II-III cancer to undergo chemotherapy treatment for the first time. The sample of the study consisted of 30 patients who were assigned to the intervention and control groups by the stratified sampling method (considering such characteristics as age, gender, marital status). The patient identification form, Spielberger state anxiety scale, patient opinion form, vital signs follow-up form, and virtual reality glasses were used to collect the data.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 060
        • Bahar İnkaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Diagnosed with stage 1,2,3 cancer
  • Receive radiotherapy and chemotherapy for the first time
  • Volunteer patients who agreed to participate

Exclusion Criteria:

-Patients outside the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Virtual reality glasses
In the research, Samsung Gear VR SM-R323 brand and model SG glasses provided by the researcher were used. Patients were offered four different options to watch as "Forest of Serenity", "Calm Place", "Happy Place", "Gala 360 Travel & Relax". Forest of Serenity is a nature video consisting of bird sounds, colorful trees and flowers, and a clear lake where fish can be seen swimming in it. Calm Place is a relaxing video where cycles are shown 24 hours a day, where a person finds himself by the lake in the forest in snowy, rainy sunny weather. In Happy Place, one finds himself in a virtual camp environment where natural events such as dynamically changing weather, day-night cycles, and falling stars are experienced. Gala 360 Travel & Relax is a Paris-Notre Dame museum tour video.
Device: Virtual Glasses
In the research, Samsung Gear VR SM-R323 brand and model SG glasses provided by the researcher were used. Patients were offered four different options to watch as "Forest of Serenity", "Calm Place", "Happy Place", "Gala 360 Travel & Relax". Forest of Serenity is a nature video consisting of bird sounds, colorful trees and flowers, and a clear lake where fish can be seen swimming in it. Calm Place is a relaxing video where cycles are shown 24 hours a day, where a person finds himself by the lake in the forest in snowy, rainy sunny weather. In Happy Place, one finds himself in a virtual camp environment where natural events such as dynamically changing weather, day-night cycles, and falling stars are experienced. Gala 360 Travel & Relax is a Paris-Notre Dame museum tour video.
Other: Scales
Spielberger State Anxiety Inventory Vital Signs Follow-up Form
Device: Virtual Glasses
In the research, Samsung Gear VR SM-R323 brand and model SG glasses provided by the researcher were used. Patients were offered four different options to watch as "Forest of Serenity", "Calm Place", "Happy Place", "Gala 360 Travel & Relax". Forest of Serenity is a nature video consisting of bird sounds, colorful trees and flowers, and a clear lake where fish can be seen swimming in it. Calm Place is a relaxing video where cycles are shown 24 hours a day, where a person finds himself by the lake in the forest in snowy, rainy sunny weather. In Happy Place, one finds himself in a virtual camp environment where natural events such as dynamically changing weather, day-night cycles, and falling stars are experienced. Gala 360 Travel & Relax is a Paris-Notre Dame museum tour video.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital signs- Blood pressure
Time Frame: first measurement just before the start of the chemotherapy infusion
Systolic blood pressure values
first measurement just before the start of the chemotherapy infusion
Vital signs-pulse
Time Frame: first measurement just before the start of the chemotherapy infusion
Pulse values
first measurement just before the start of the chemotherapy infusion
Vital signs- Blood pressure
Time Frame: the last measurement just after the end of the chemotherapy infusion
Systolic blood pressure values
the last measurement just after the end of the chemotherapy infusion
Vital signs-pulse
Time Frame: the last measurement just after the end of the chemotherapy infusion
Pulse values
the last measurement just after the end of the chemotherapy infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahar İNKAYA

Investigators

  • Study Chair: SEBILE OZDAG, Hacettepe University Adult Oncology Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2020

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

January 21, 2022

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Ankara Yilidirim Beyazit Un.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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