Clinical trial NCT05509114: The Effect of Virtual Reality Glasses Application on Pain, Anxiety, and Patient Satisfaction
Official title: The Effect of Virtual Reality Glasses Application on Pain, Anxiety, and Patient Satisfaction During a Transrectal Prostate Biopsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate
Keywords: anxiety, pain, patient satisfaction, virtual reality
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was conducted in a randomized controlled manner to determine the effect of applying virtual reality glasses during transrectal prostate biopsy on pain, anxiety and patient satisfaction.The study was completed with a total of 70 patients, 35 in the intervention group and 35 in the control group, for whom it was decided to perform sample transrectal prostate biopsy for the first time.

Detailed description: Although prostate cancer is the most common type of cancer in men, according to 2018 data published by the International Agency for Research on Cancer, it is the second most common after lung cancer worldwide.The prevalence of prostate cancer is increasing rapidly worldwide. However, when prostate cancer is diagnosed early, the survival rate increases with the effect of the treatment methods applied. Digital rectal examination (DRE), prostate specific antigen (PSA) level, and transrectal ultrasonography-guided prostate biopsy (TRUS-Bx) methods are used for diagnosis. Transrectal prostate biopsy process; It is one of the most frequently performed urological procedures for definitive diagnosis in patients with a PSA value above the normal limit and abnormal DRE findings. Transrectal prostate biopsy is a golden diagnostic tool in prostate cancer because it is typically well tolerated, treatable, and has a low risk of major complications. However, in addition to the advantages of this procedure, it also has disadvantages such as causing pain and discomfort in patients.Prostate biopsy procedure affects patients not only physiologically but also psychologically. Interventional procedures cause patients to experience the highest level of anxiety. With the development of technology, developments in health care have brought the concept of patient satisfaction to the fore. Applications made in line with patient expectations in order to increase the quality of care make a significant contribution to the perception of nursing care. One of these applications, virtual reality glasses, make patients feel like they are in a different world; increases patient satisfaction. Nurses, who are members of the profession who plan and manage care, because they spend longer time with the patient; They play an active role in defining pain and anxiety by using pharmacological and non-pharmacological methods. When examining the literature, there was no study examining the effect of virtual reality application on the pain level of patients during the transrectal prostate biopsy procedure, but no study examining the effect on the level of anxiety and patient satisfaction. In this study; It is aimed to increase patient satisfaction by reducing the pain and anxiety of the patients with virtual reality applied during the transrectal prostate biopsy procedure. It is thought that the results of this study can make an important contribution to both the literature and practice.

Eligibility criteria: Inclusion Criteria:

* Those between the ages of 18-65,
* Those who volunteer and accept to participate in the research,
* Transrectal prostate biopsy procedure performed for the first time,
* No communication problem,
* Cognitive level scales are suitable for application,
* Patients without vision or hearing problems were included in the study.

Exclusion Criteria:

* Leaving work voluntarily,
* Patients whose cognitive level scales were not suitable for application were excluded from the study.

Primary outcomes:
measure: State-Trait Anxiety İnventory (STAI-I, STAI-II)
timeFrame: up to 24 hours
measure: The Scale of Patient Perception of Hospital Experience with Nursing Care (PPHEN)
timeFrame: up to 24 hours
measure: Visual Analog Scale for Pain (VAS)
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Palandöken
country: Turkey
facility: Rumeysa Lale TORAMAN
state: Erzurum
Study officials:
affiliation: Ataturk University
name: Rumeysa Lale TORAMAN
role: PRINCIPAL_INVESTIGATOR
References: