Virtual Reality Glasses and Stress Ball Applications in Dressing Change

June 20, 2024 updated by: Altun Baksi, Suleyman Demirel University

Examination of the Effects of Virtual Reality Glasses and Stress Ball Applications on Pain, Vital Signs Anxiety, Fear, Satisfaction, and Comfort Levels During the Dressing Changes in Patients Who Underwent Abdominal Surgery

According to the statistical data of the Ministry of Health for the year 2021 in Türkiye, approximately 4.7 million surgical interventions are performed annually. According to the 2017 data from the National Health Service-Associated Infections Surveillance Network, the Surgical Site Infection (SSI) rate in our country is 0.72%, and it is stated that it can be prevented by approximately 60%. Dressing application holds an important place in surgical wound management, wound healing, and preventing complications. Patients may experience pain, anxiety, and fear due to unknown factors and previous experiences during the dressing change which holds an important place in wound care management. The aim is to minimize patients' negative emotions/situations during dressing changes by diverting their attention elsewhere using virtual reality (VR) glasses and stress balls. Upon reviewing the literature, no study was found that examines the effect of applying VR glasses and stress balls during abdominal surgery dressing changes on pain, vital signs, anxiety, fear, comfort, and satisfaction levels in adults. In this regard, the aim of the research is; to examine the effects of VR glasses and stress ball application on pain, vital signs, anxiety, fear, comfort, and satisfaction levels during dressing changes in patients undergoing abdominal surgery. The study was designed as a pre-test post-test control group randomized experimental model. The sample of the study consists of adult patients who underwent abdominal surgery in Isparta City Hospital General Surgery Service-1. In the study sample, 120 individuals were included in total 40 with VR glasses, 40 individuals using stress balls, and 40 in the control group. Patient Information Form, Visual Analog Scale, and State-Trait Anxiety Scale will be used in data collection. Data from the study will be analyzed with number, percent, average, x-square, variance, and t-test in a computer environment. In consideration of the data, it is believed that important findings will be obtained in increasing satisfaction and comfort by eliminating pain, anxiety, and fear during dressing changes in patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acceptance to participate in the study both in writing and verbally.
  • Being over 18,
  • Having undergone abdominal surgery,
  • Being on the 1st day after surgery,
  • Being subjected to first dressing after surgery,
  • Staying in the one-person room or being the only patient in the room,
  • Being conscious (person, place and time orientation),
  • Patients who have no vision, hearing or communication problems will be included in the study.

Exclusion Criteria:

  • Patients using analgesic, anxiolytic, and sedative medications before, during, and immediately after dressing changes.
  • Having chronic pain disorder
  • Having a disease that may affect primarily vital signs (such as Hypertension, COPD),
  • Not having any psychiatric and cognitive/mental disease (dementia, etc.),
  • Having chronic diseases like epilepsy, vertigo,
  • Being diagnosed with vision, hearing(auditory) and/or balance disorder
  • Having an addiction or abusing alcohol or drugs.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual Reality Glasses Group
Apart from the routine clinic procedure, VR video scenes (contain nature views) will be watched for 5-10 minutes during the procedure.
Device: Virtual Reality Glasses Group
Apart from the routine clinic procedure, VR video scenes (contain nature views) will be watched for 5-10 minutes during the procedure.
Experimental: Stress Ball Group
Apart from the routine clinic procedure, it will be asked squeezing the stress ball for about 5-10 minutes (squeezing it once every time he counts to five)during the procedure.
Device: Stress Ball Group
Apart from the routine clinic procedure, it will be asked squeezing the stress ball for about 5-10 minutes (squeezing it once every time he counts to five)during the procedure.
No Intervention: Control Group
Only dressing will be changed just as routine clinic procedure without any intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient Information Form
Time Frame: Pre-test data will be collected from all three groups 10-15 minutes before the procedure.
This form created by researchers, consists of a total of 14 questions. These questions include patients' age, gender, education level, marital status, employment status, income level, chronic disease status, history of previous surgeries, reason for hospital admission, knowledge about colonoscopy, preference for the current method if another colonoscopy is required, and inquiry about the use of additional sedation and painkillers during the procedure.
Pre-test data will be collected from all three groups 10-15 minutes before the procedure.
Visual Analog Scale (Visual Analog Skala-VAS)
Time Frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
The scale is a valid tool for measuring psychological and health variables such as pain and satisfaction, which are commonly used in clinical studies. It is a scale where the distance between two ends, with a minimum value of 0 at one end and a maximum value of 10 at the other end, is measured with a 10 cm ruler. (Price, 1983). The scale will be used to determine the pain, fear, satisfaction, and comfort levels of patients who underwent abdominal surgery during dressing changes. In this regard: It is explained to the patient that there are two extreme points and he is free to mark any place between these points that is convenient for him. The interval between the beginning of "No pain, fear, satisfaction, and comfort" and the point marked by the patient is measured and recorded in centimeters.
Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
State Anxiety Inventory (In State-Trait Anxiety Inventory)
Time Frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure.
The scale is a valid and reliable scale adapted to Turkish. State anxiety inventory consists of two different scales including 40 items that individuals may use to express their emotions. The first twenty of these items, the state anxiety inventory determines persons' worry tendency due to individual characteristics. Statements in the scale are presented in the form of direct and inverted expressions. The scale was scored by giving four options for each statement. Spielberger and his colleagues state that scores ranging from 0 to 19 indicate no anxiety, 20 to 39 indicate mild anxiety, 40 to 59 indicate moderate anxiety, and scores of 60-79 indicate severe anxiety, also individuals with a score of 60 and above require professional help. This scale will be used to determine the state anxiety status of patients who underwent abdominal surgery in this study.
Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure.
Trait Anxiety Inventory (In State-Trait Anxiety Inventory)
Time Frame: Pre-test data will be collected from all three groups 10-15 minutes before the procedure.
The scale is a valid and reliable scale adapted to Turkish. State-trait anxiety inventory consists of two different scales including 40 items that individuals may use to express their emotions. The items from 21 to 40 on the scale, trait anxiety inventory, were prepared to determine anxiety felt by the individual due to stressful situations. Similarly, each statement has been scored with four options.Points obtained from both scales range between 20 and 80. Spielberger and his colleagues state that scores ranging from 0 to 19 indicate no anxiety, 20 to 39 indicate mild anxiety, 40 to 59 indicate moderate anxiety, and scores of 60-79 indicate severe anxiety, also individuals with a score of 60 and above require professional help. This scale will be used to determine the trait anxiety status of patients who underwent abdominal surgery in this study.
Pre-test data will be collected from all three groups 10-15 minutes before the procedure.
Vital signs-pulse
Time Frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Patients' pulse levels
Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Vital signs-systolic blood pressure
Time Frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Patients' systolic blood pressure levels
Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Vital signs-diastolic blood pressure
Time Frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Patients' diastolic blood pressure levels
Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Vital signs-fever
Time Frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Patients' fever levels
Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Vital signs-respiratory rate
Time Frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Patients' respiratory rate levels
Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Vital signs-oxygen saturation
Time Frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Patients' oxygen saturation levels
Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suleyman Demirel University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Altun Baksi, PhD, Suleyman Demirel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22/326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All IPD that underlie results in a publication

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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