The Effect of Different Images Watched With Virtual Reality During Phlebotomy

NCT06487520 | Completed

• 1 other identifier: 2019/04-18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management; Anxiety Management; Blood Donation; Virtual Reality

Keywords

Pain; Anxiety; Phlebotomy; Blood Donation; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• pain intensity in cm

  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.

  6 months

• State-Trait Anxiety Inventory (STAI) score

  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.

  6 months

Secondary Outcomes (2)

• weight in kilograms

  6 months

• Pressure pain threshold

  6 months

Study Arms (3)

group watching hot environment image

EXPERIMENTAL

A virtual reality headset was placed on the heads of the individuals included in the intervention group one minute before the procedure and a cold environment image called "Peaceful mountain snow" was shown. By starting the image before the procedure, the individual was prevented from seeing the needle and blood. At the end of the procedure, the tourniquet and needle were removed and the virtual reality headset was removed from the individual's head and the displayed image was terminated.

Other: group watching hot environment image

group watching cold environment image

PLACEBO COMPARATOR

A virtual reality headset was placed on the heads of the individuals in the placebo group one minute before the procedure and a warm environment image called "Deep space relaxation" was shown. By starting the image before the procedure, the individual was prevented from seeing the needle and blood. At the end of the procedure, the tourniquet and needle were removed and the virtual reality headset was removed from the individual's head and the image shown was terminated

Other: group watching cold environment image

The control group

NO INTERVENTION

No intervention was performed on the control group before the peripheral intravenous catheterization procedure, and the standard peripheral intravenous catheterization procedure was performed.

Interventions

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 hot environment image

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.

group watching cold environment image

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bulent Ecevit University

Zonguldak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Zonguldak Bulent Ecevit University, Ahmet Erdogan Health Services Vocational School, Health Care Services Program

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: April 18, 2019
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: July 5, 2024

Record last verified: 2024-06

Locations

TU (1)