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The Effect of Virtual Reality on Pain and Anxiety During Blood Collection in Adults

Primary Purpose

Adult, Virtual Reality, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adult focused on measuring Adults, Virtual Reality, Anxiety, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Necmettin Erbakan University Medical Faculty HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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.

The control group will receive standard procedure without any intervention

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 29, 2022
Last Updated
August 16, 2022
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT05366556
Brief Title
The Effect of Virtual Reality on Pain and Anxiety During Blood Collection in Adults
Official Title
The Effect of Virtual Reality on Pain and Anxiety During Blood Collection in Adult Patients: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KTO Karatay University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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. Pain and anxiety because of invasive procedures lead to prolongation of the examination period and treatment procedures, and the rejection of treatment. Various distraction methods such as pharmacological local anesthetic creams, non-pharmacologically vibrating tourniquet, buzzy device, virtual reality have been used to reduce pain during invasive procedures. Vibrating tourniquet application during blood collection in pediatric patients was found to be effective on the pain felt. In another study conducted in pediatric patients, it was found that using a buzzy device, watching cartoons, and playing digital games during blood collection were effective in pain and fear management. Virtual reality is defined as "a technology that allows three-dimensional pictures and animations created in the computer environment to interact with these objects in the environment, which gives the feeling of being in a real environment in people's minds with technological tools". In the studies, virtual reality was applied in many studies during blood collection in pediatric patients. It was found that children who used virtual reality during invasive procedures in the pediatric nephrology clinic reported lower pain intensity and stress level compared to the control group. In the literature, research involving an attempt to reduce pain and anxiety during blood collection in adult patients has been found and studies involving attempts to reduce pain and anxiety during other invasive procedures are limited. In a study examining the pain and fear of adult outpatients during the treatment, it was found that the pain and anxiety levels of the virtual reality application group were low and they were highly satisfied with virtual reality. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult, Virtual Reality, Anxiety, Pain
Keywords
Adults, Virtual Reality, Anxiety, Pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
Single Blinded
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive standard procedure without any intervention
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
State Anxiety Scale mean score
Description
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.
Time Frame
10 minute
Title
Visual Analog Scale mean score
Description
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.
Time Frame
2 minute (during the process)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients with visual or hearing impairment Patients whose blood cannot be drawn in once
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serap SAYAR, PhD
Phone
+905059102994
Email
oranserap@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Magbul Ahmet Çoban, MScN student
Phone
+905315153703
Email
ahmetcoban7070@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serap SAYAR, PhD
Organizational Affiliation
KTO Karatay University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Magbul Ahmet Çoban, MScN student
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necmettin Erbakan University Medical Faculty Hospital
City
Konya
ZIP/Postal Code
42020
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magbul Ahmet Çoban, Nurse
Phone
05315153703
Email
ahmetcoban7070@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The researcher at Necmettin Erbakan University will collect the data

Learn more about this trial

The Effect of Virtual Reality on Pain and Anxiety During Blood Collection in Adults

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