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Completed

NCT Number: NCT06487520

The Effect of Different Images Watched With Virtual Reality During Phlebotomy

Aim: The purpose of this study was to investigate the effect of watching a cold environment image via virtual reality on pain and anxiety related to phlebotomy procedure in volunteer blood donors.

Methods: The study was conducted between June 2019 and December 2019 with 120 healthy individuals who applied for blood donation for the first time in Northern Turkey. Individuals included in the study were assigned to intervention, placebo and control groups with 40 people in each group by block randomization method. During the phlebotomy procedure, the intervention group watched a cold environment image via virtual reality, the placebo group watched a hot environment image, and the control group received standard application. "Descriptive Characteristics Form", "Visual Comparison Scale", "State and Trait Anxiety Inventory" and The CONSORT checklist were used to collect data.

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Key information

Conditions

Pain Management Agnosia Anxiety Disorders Anxiety Management Blood Donation Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Virtual Reality

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zonguldak Bulent Ecevit University

Zonguldak, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being in accordance with time and place
  • Being aged between 18 and 35 years
  • Being able to evaluate the visual analog scale correctly
  • Participating voluntarily in the research.
  • Being willing to donate blood
  • Donating blood for the first time
  • Have a body mass index within normal limits (18.5-24.9 kg/m2)
  • Have no vision or hearing problems
  • Have no disease that may affect pain perception
  • Have no vertigo, heart or lung disease
  • Have no signs of infection, dermatitis, phlebitis, scar tissue or incision in the area where invasive intervention will be performed
  • Have no psychiatric disease
  • Being able to accurately assess the state and trait anxiety inventory with the VAS
  • Have an average pressure pain threshold value of 8-16 Lb obtained from three measurements taken at 5-second intervals from the elbow region of the left upper extremity where no intervention was performed
  • Have no vertigo, heart or lung disease
  • Have no signs of infection, dermatitis, phlebitis, scar tissue or incision in the area where invasive intervention will be performed
  • Have no psychiatric disease
  • Being able to accurately assess the state and trait anxiety inventory with the VAS
  • Have an average pressure pain threshold value of 8-16 pounds (Lb) obtained from three measurements taken at 5-second intervals from the elbow region of the left upper extremity where no intervention was performed

Exclusion criteria

  • Not participating voluntarily in the research
  • Not fitting the inclusion criteria of the research
  • Having a vision or hearing problem
  • Failure of phlebotomy at the first attempt
  • Development of syncope after phlebotomy

Treatment and study plan

group watching hot environment image

Other

In this study, Sony playstation VR (Virtual Reality) glasses with LCD (Liquid Crystal Display) screen with OLED (Organic Light-Emitting Diode) technology and 1080P resolution integrated on the device were used. These glasses work integrated with the processor box. The processor box, which provides communication with the Sony playstation VR glasses, can also be connected to the computer with HDMI (High Definition Multimedia Interface) output. Within the scope of the study, the licensed "Peaceful mountain snow" image was shown. This image includes a cold winter day.

Following the completion of every VR session, the removable face pad was replaced and the goggles and headsets were wiped down with alcohol-based sanitary wipes. Preventing infection via the sharing of the technology was a paramount issue with the study patients.

group watching cold environment image

Other

In this study, Sony playstation VR (Virtual Reality) glasses with LCD (Liquid Crystal Display) screen with OLED (Organic Light-Emitting Diode) technology and 1080P resolution integrated on the device were used. These glasses work integrated with the processor box. The processor box, which provides communication with the Sony playstation VR glasses, can also be connected to the computer with HDMI (High Definition Multimedia Interface) output. Within the scope of the study, the licensed "Deep space relaxation" image was shown. This image contains a hot environment image with explosions in space.Following the completion of every VR session, the removable face pad was replaced and the goggles and headsets were wiped down with alcohol-based sanitary wipes. Preventing infection via the sharing of the technology was a paramount issue with the study patients.

Primary outcomes

  1. pain intensity in cm

    Time frame: 6 months

    The VAS is a 100 mm (10 cm) ruler that can be used horizontally or vertically. The value of "0" at the starting level defines painlessness, and the value of "10" at the ending level defines the most severe pain. The individual marks the intensity of pain they experience on this scale. In this study, the score measurements were determined in centimeters (cm) on the VAS prepared vertically to determine the intensity of pain experienced by individuals during phlebotomy application.individuals.during the procedure. One end indicated lack of pain and the other the most.Pain intensity was evaluated in centimeters.severe pain possible. Pain severity was evaluated in millimeters.

  2. State-Trait Anxiety Inventory (STAI) score

    Time frame: 6 months

    The inventory is in the form of a 4-point Likert scale, and the items in the State and Trait Anxiety Subscales are marked according to the degree of severity of the emotions and behaviors. There are ten items in the State Anxiety Scale and seven items in the Trait Anxiety Scale that contain reversed statements.

Secondary outcomes

  1. weight in kilograms

    Time frame: 6 months

    Body mass index normal weight (18.5-24.9 kg/m2)

  2. Pressure pain threshold

    Time frame: 6 months

    The average value of the pressure pain threshold, which is defined as the point of pain.from three measurements taken at 5-second intervals from the elbow region of the left upper extremity where no intervention was performedperception and can vary from person to person, is between 8-16 Lb

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Official study title

The Effect of Different Images Watched Wiht Virtual Reality on Perception of Pain And Anxiety During Flebotomy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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