NCT06923982

Brief Summary

The aim of this study is to determine the level of pain and comfort associated with the implementation of virtual reality prior to nursing care in patients undergoing treatment in the intensive care unit. The research will be conducted in the Internal Medicine Intensive Care Unit of a university hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

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

July 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

March 21, 2024

Last Update Submit

April 5, 2025

Conditions

Keywords

nursingvirtual realitypaincomfortintensive care unit

Outcome Measures

Primary Outcomes (3)

  • Change in Pain Level Measured by Visual Analog Scale (VAS) Before and After Nursing Care

    Pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. Pain levels will be measured before care and again 24 hours after nursing care, and compared between the experimental and control groups.

    24 hours

  • Change in Overcoming Problems Sub-dimension and General Comfort Level (GCS-SF) After Virtual Reality Application

    Comfort will be assessed using the General Comfort Scale - Short Form (GCS-SF), including the "overcoming problems" sub-dimension. The GCS-SF total score ranges from 24 to 96, with higher scores indicating greater comfort. Scores will be measured 24 hours after the virtual reality application in both the experimental and control groups.

    24 hours

  • Change in Refreshment/Comfort Sub-Dimension Scale Score After Virtual Reality Application

    Comfort will be evaluated using the Refreshment/Comfort sub-dimension of the General Comfort Scale - Short Form (GCS-SF). Scores range from 8 to 32, with higher scores indicating greater comfort. Scores will be measured 24 hours after the virtual reality application in both the experimental and control groups.

    24 hours

Other Outcomes (1)

  • Satisfaction Survey Score Related to the Use of Virtual Reality Glasses in the Experimental Group

    24 hours

Study Arms (1)

virtual reality

OTHER

During care, patients are given a duration of 3-10 minutes. virtual reality glasses (VR box 2.0 virtual glasses) for a total of 15 minutes walks in parks, nature and seaside with music background, with reality glasses (6.5 inches), videos that the patient wants to watch and whenever he/she wants, such as underwater or museum tours. Videos that could be changed were shown.

Other: virtual reality, experimental groupOther: control group

Interventions

Socio-demographic characteristics form questions were asked to individuals in the intervention group before care. During the care, patients are given virtual reality glasses (VR box 2.0 virtual reality glasses and 6.5 inch) for a total of 15 minutes, ranging from 3 to 10 minutes, and watch videos that the patient wants to watch, such as park, nature and seaside walks, undersea and museum trips, with a music background. and he was shown videos that he could change at any time. After the maintenance, Visual Analog Scale-Pain (VAS-P) scale, General Comfort Level Scale and Satisfaction Evaluation Scale for Virtual Reality Glasses Application questions were applied. 24 hours after the care, VAS-P and General Comfort Level Scale were administered again.

virtual reality

A socio-demographic questionnaire was administered to the control group before care. During maintenance, no intervention was applied and standard care in routine practice was applied. After the care, Visual Analog Scale-Pain (VAS-P) scale and General Comfort Scale were applied. 24 hours after the treatment, the Visual Analog Scale-Pain (VAS-P) scale and the General Comfort Scale were applied again.

virtual reality

Eligibility Criteria

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

You may qualify if:

  • Individuals who are hospitalized in the intensive care unit (with diagnoses such as cancer, chronic renal failure, heart failure, gastrointestinal bleeding, COPD, DM, etc.) and volunteer to participate in the study.
  • Between the ages of 18-65,
  • Having clear consciousness, orientation to place, time and person, and having a GCS score of 10 and above,
  • Individuals who do not have any hearing or visual impairment,
  • They were determined as individuals who were not on mechanical ventilation support.

You may not qualify if:

  • Receiving mechanical ventilation support
  • Individuals under 18 years of age and over 65 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çankırı Karatekin Üniversitesi

Çankırı, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHeart FailureRenal InsufficiencyGastroesophageal RefluxPain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
In the experimentally planned study, patients diagnosed with cancer hospitalized in the 10-bed internal medicine intensive care unit at Eskişehir Osmangazi University Hospital were first evaluated in terms of the inclusion criteria, and individuals who did not meet the criteria were excluded from the study. Eligible individuals were included in one of the intervention group and control groups using virtual reality glasses by randomization method. The lottery method was used to randomize individuals to research groups. In this method, 30 pieces of red and blue paper were placed into 2 black fabric bags by the researcher. Red paper represents the intervention group and blue paper represents the control group. Individuals who met the inclusion criteria and agreed to participate in the study were asked to randomly choose a piece of paper from the bags. In this way, the groups were automatically balanced.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Two groups were taken as experimental and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Nurse

Study Record Dates

First Submitted

March 21, 2024

First Posted

April 11, 2025

Study Start

July 1, 2022

Primary Completion

December 31, 2022

Study Completion

January 15, 2024

Last Updated

April 11, 2025

Record last verified: 2025-04

Locations