NCT05366556

Brief Summary

In hospitals, venous blood sampling as the first step in diagnosis and planning of medical treatment is among the most basic and common procedures all over the world. Before the diagnosis and treatment of acute or chronic health problems, venous blood is requested from the doctors and the blood sample is collected by the nurses. Patients experience anxiety for reasons such as the fear of experiencing pain during the blood donation process, fear of seeing blood, and fear that blood-borne diseases will pass. Studies in the literature have generally evaluated the effects on pain and fear by using virtual reality with different techniques in pediatric patients during blood collection, and the relevant research has been reached in adult patients. The aim of this research is to determine the effect of virtual reality on pain and anxiety during blood collection of patients who applied to the blood collection unit of a university hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

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

March 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2022

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

April 29, 2022

Last Update Submit

November 23, 2023

Conditions

Keywords

AdultsVirtual RealityAnxietyPain

Outcome Measures

Primary Outcomes (2)

  • State Anxiety Scale mean score

    State Anxiety Scale mean scores of adult patients in the intervention and control groups will be compared before and after the intervention. A minimum of 20 and a maximum of 80 points can be obtained from the scale. If the scale score approaches 80, it indicates high anxiety.

    10 minute

  • Visual Analog Scale mean score

    Mean Visual Analog Scale scores for adult patients of the intervention and control groups will be compared at the time of intervention.The minimum score to be taken from the scale is zero, the maximum score is 10. It shows that the severity of pain increases as the Visual Analog Scale score approaches 10 during blood collection.

    2 minute (during the process)

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients in the experimental group will be informed about the using virtual reality glasses during the taking blood. During this process, their anxiety and pain will be assesed. Patients in the study group will be evaluated 2 times, before the intervention and after the intervention, through data collection tools.

Behavioral: Virtual reality

Control group

NO INTERVENTION

The control group will receive standard procedure without any intervention

Interventions

Virtual realityBEHAVIORAL

The patient, whose blood will be drawn, will be asked to wear virtual reality glasses after sitting in the blood collection chair. One minute before the start of the blood collection process, "Nature Hiking" will be watched from the virtual reality. Meanwhile, the researcher will complete the preparations for blood collection and will start the blood collection process. It is thought that the blood collection process takes 2-3 minutes on average. During this period, virtual reality will be applied. While blood is being drawn from the patient, the researcher will assess the patient's level of pain with the VAS during the procedure. After the blood draw is completed, the virtual reality glasses will be removed. Then, the patient will be taken to the waiting area and the state anxiety scale will be applied.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Voluntarily agreed to participate in the research.
  • Being 18 years or older
  • Being able to read and write Turkish
  • No vision and hearing problems
  • Not using glasses
  • Absence of any psychiatric, cognitive or neurological disease

You may not qualify if:

  • Patients with visual or hearing impairment
  • Patients whose blood cannot be drawn in once

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University Medical Faculty Hospital

Konya, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Serap SAYAR, PhD

    KTO Karatay University

    STUDY DIRECTOR
  • Magbul Ahmet Çoban, MScN student

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single Blinded
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The adult patients will be divided into two as the experimental and control group. Patients in the experimental group will be informed about the using virtual reality glasses during the taking blood. During this process, their anxiety and pain will be assesed. Patients in the study group will be evaluated 2 times, before the intervention and after the intervention, through data collection tools.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PhD

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 9, 2022

Study Start

March 10, 2022

Primary Completion

September 12, 2022

Study Completion

September 12, 2022

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

The researcher at Necmettin Erbakan University will collect the data

Locations