Pain ManagementNCT06487520
The Effect of Different Images Watched With Virtual Reality During Phlebotomy
A study testing group watching hot environment image and group watching cold environment image in people with Pain Management and Anxiety Management, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Anxiety Management, Blood Donation
- What is being tested?
- group watching hot environment image and group watching cold environment image
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2019to 10 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Images Watched Wiht Virtual Reality on Perception of Pain And Anxiety During Flebotomy
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
- Being tested
- group watching hot environment image, group watching cold environment image
- Keywords
- Pain, Anxiety, Phlebotomy, Blood Donation, Virtual Reality
- Medical subject headings
- Agnosia, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group watching hot environment imageOther
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 imageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
weight in kilograms
Body mass index normal weight (18.5-24.9 kg/m2)
Measured: 6 months
Pressure pain threshold
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start18 Apr 2019
- Primary completion10 Jul 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Karaman, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487520
- Sponsor's protocol ID
- 2019/04-18
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Images Watched Wiht Virtual Reality on Perception of Pain And Anxiety During Flebotomy
- ClinicalTrials.gov ID
- NCT06487520
- Acronym / sponsor ID
- 2019/04-18
- Conditions
- Pain Management, Anxiety Management, Blood Donation, Virtual Reality
- Keywords
- Pain, Anxiety, Phlebotomy, Blood Donation, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group watching hot environment image | Experimental | Other: group watching hot environment imageA 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. |
| group watching cold environment image | Placebo comparator | Other: group watching cold environment imageA 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 |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group watching hot environment imageIn 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. | Other | group watching hot environment image |
| group watching cold environment imageIn 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. | Other | group watching cold environment image |
Primary outcome
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.
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.
2 secondary outcomes
weight in kilograms
Time frame: 6 months
Pressure pain threshold
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Pain Management
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group watching hot environment image and group watching cold environment image in people with Pain Management and Anxiety Management, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity in cm (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.