Virtual Reality Glasses and Stress Ball Applications in Dressing Change

NCT ID: NCT06476314

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-01-31

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' 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.

Conditions

Surgical Wound; Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality Glasses Group

Intervention Type: DEVICE

Apart from the routine clinic procedure, VR video scenes (contain nature views) will be watched for 5-10 minutes during the procedure.

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.

Group Type: EXPERIMENTAL

Stress Ball Group

Intervention Type: DEVICE

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.

Control Group

Only dressing will be changed just as routine clinic procedure without any intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suleyman Demirel University

OTHER

Sponsor Role: lead

Responsible Party

Altun Baksi

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Altun Baksi, PhD

Role: PRINCIPAL_INVESTIGATOR

Suleyman Demirel University

Central Contacts

Altun Baksi, PhD

Role: CONTACT

altunbaksi@sdu.edu.tr

+90 505 397 32 46

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Other Identifiers

22/326

Identifier Type: -

Identifier Source: org_study_id