NCT05509114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 17, 2022

Last Update Submit

August 18, 2022

Conditions

Keywords

anxiety, pain, patient satisfaction, virtual reality

Outcome Measures

Primary Outcomes (3)

  • State-Trait Anxiety İnventory (STAI-I, STAI-II)

    It is a test developed by Spielberger et al. that measures state and trait anxiety levels. Its validity and reliability in Turkey was done by Öner and Le Compte. The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings, and the 20-item 'trait anxiety scale', which was created to determine the feelings in general. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety).

    up to 24 hours

  • The Scale of Patient Perception of Hospital Experience with Nursing Care (PPHEN)

    The patient's perception of nursing care scale was developed by Dozier et al. in the USA, and its Turkish validity and reliability were determined by Çoban and Kaşıkçı.Likert-type scale has 15 statements about the quality of nursing care. A minimum of 15 and a maximum of 75 points can be obtained from the scale. The cut-off point of the scale is 45. Scores above the cut-off point indicate a positive attitude. The increase in the total score obtained from the scale indicates that the patient is satisfied with the nursing care.

    up to 24 hours

  • Visual Analog Scale for Pain (VAS)

    VAS is a scale developed by Price et al34 (1983) and measures the severity of pain in the patient. VAS is a 10 cm long vertical or horizontal scale with two different names (0=no pain, 10=most severe pain). An increase in the score obtained from the scale in the evaluation indicates an increase in pain.

    up to 24 hours

Study Arms (1)

Virtual Reality Glasses

EXPERIMENTAL

The intervention introductory information formula was face-to-face by researchers from the State-Trait Anxiety Inventory (STAI-I, STAI-II), the Scale of Patient Perception of Hospital Experience with Nursing Care (PPHEN) and Visual Analog Scale for Pain (VAS) Before starting the research, a preliminary application plan is determined with 10 virtual virtual applications. It is not included in the applications made in the pre-application. Before watching the video, patients are informed about how to train, how to do it, and detailed information about the video. When the patient is removed from the service and in the left lateral position, 2 minutes before the assistant physician, the virtual is about to take place. The video was watched after about 10-15 minutes until the process was finished. After the procedure, STAI-I, STAI-II, PPHEN and VAS were reapplied by the researchers.

Device: Virtual Reality Glasses

Interventions

The intervention group of patients watched a video with virtual reality glasses during the transrectal biopsy process.

Virtual Reality Glasses

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rumeysa Lale TORAMAN

Palandöken, Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPainPatient Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Rumeysa Lale TORAMAN

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 19, 2022

Study Start

December 25, 2021

Primary Completion

June 20, 2022

Study Completion

July 27, 2022

Last Updated

August 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations