Clinical trial NCT06476314: Virtual Reality Glasses and Stress Ball Applications in Dressing Change
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgical Wound
Abdominal Surgery
Keywords: Dressing
surgical wound
incision
virtual reality glasses
stress ball
nursing care
pain
vital signs
anxiety
fear
satisfaction
comfort levels
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment experimental model using randomized pretest and posttest with control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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\&#39; 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient Information Form
timeFrame: Pre-test data will be collected from all three groups 10-15 minutes before the procedure.
measure: Visual Analog Scale (Visual Analog Skala-VAS)
timeFrame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
measure: State Anxiety Inventory (In State-Trait Anxiety Inventory)
timeFrame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure.
measure: Trait Anxiety Inventory (In State-Trait Anxiety Inventory)
timeFrame: Pre-test data will be collected from all three groups 10-15 minutes before the procedure.
measure: Vital signs-pulse
timeFrame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
measure: Vital signs-systolic blood pressure
timeFrame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
measure: Vital signs-diastolic blood pressure
timeFrame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
measure: Vital signs-fever
timeFrame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
measure: Vital signs-respiratory rate
timeFrame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
measure: Vital signs-oxygen saturation
timeFrame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Suleyman Demirel University
name: Altun Baksi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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