Clinical trial NCT06487520: The Effect of Different Images Watched With Virtual Reality During Phlebotomy
Official title: The Effect of Different Images Watched Wiht Virtual Reality on Perception of Pain And Anxiety During Flebotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Anxiety Management
Blood Donation
Virtual Reality
Keywords: Pain
Anxiety
Phlebotomy
Blood Donation
Virtual Reality
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: pain intensity in cm
timeFrame: 6 months
measure: State-Trait Anxiety Inventory (STAI) score
timeFrame: 6 months
Secondary outcomes:
measure: weight in kilograms
timeFrame: 6 months
measure: Pressure pain threshold
timeFrame: 6 months
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bulent Ecevit University
Study officials:
References: