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CompletedNCT05422287Updated Jun 16, 2022

Effect of Thermomechanical Stimulation Device and Virtual Reality Glasses During Peripheral Intravenous Catheterization

An interventional study of Virtual Reality Glasses and Thermomechanical Stimulation Device in Catheterization, sponsored by Ankara Yildirim Beyazıt University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-16.

Sponsored by Ankara Yildirim Beyazıt University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Apr 2021, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The study was conducted as a randomized controlled experimental study to determine the effect of Thermomechanical Stimulation Device (Buzzy®) and Virtual Reality Goggles (VRG) applied during peripheral intravenous catheterization (PIC) on pain and patient satisfaction in adult patients.

Read the detailed description

The research was carried out at the Emergency Department of the Etimesgut Şehit Sait Ertürk State Hospital in Ankara from April 2021 to February 2022. The sample of the study consisted of 126 adult patients. The patients were divided into three groups by randomization method. VRG was applied to the first group, Buzzy to the second group and the control group which was the third group using the standard procedure. Before the procedure of PIC, "Introductory Characteristics Form for Patients" was prepared by the researcher containing the sociodemographic characteristics of the participants (gender, marital status, age, educational status, etc. as such). This form was filled out by asking the patient by face-to-face interview method. After catheterization, the "Visual Comparison Scale for Pain" was used by the nurse practitioner to determine the pain of the patients and the "Visual Comparison Scale for Satisfaction" was used to determine the satisfaction status of the patients regarding the application to be performed. It is expected that pain and patient satisfaction scores in groups where a VRG and Buzzy® were used during PIC in adult patients will result more positively than in the control group. It is thought that the results obtained from the research will contribute to the literature.

02

Conditions studied

  • Catheterization

Keywords

  • Nursing
  • pain
  • patient satisfaction
  • peripheral intravenous catheterization
  • thermomechanical stimulation
  • virtual reality
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 126 is above the median of 70 across 2,101 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Ankara Yildirim Beyazıt University is the lead sponsor of 238 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Shold be a volunteer to participate in the research
  • Should be in the age of between 18-65 years old
  • Should not use drugs that will have an analgesic effect in the last 24 hours before admission
  • Should have successful of the first intravenous catheterization attempt
  • Absence of any psychiatric illness
  • Absence of any oncology and hematology disease
  • Should have the ability to read and write in Turkish,
  • Absence of vision, hearing and perception problems
  • Should not have a febrile illness at the time of applications
  • Should not have thin and damaged vascular structure
  • Absence of a history of fainting during blood removal
  • Should be conscious, fully oriented and cooperative, and open to communication

Exclusion criteria

Exclusion Criteria:

  • Failure of the first attempt to administer intravenous catheterization
  • The unwillingness of the patient to continue the research
  • Removing the virtual reality glasses before and during the procedure
  • Discontinuing of Buzzy ® before and during the procedure
  • Deterioration of the patient's health status during the procedure
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
126 participants (actual)

Study arms

  • Experimental
    Virtual Reality Glasses (VRG) Group

    The participants in this group were started to watch videos by wearing virtual reality glasses about 2 minutes before the catheterization process was started and the process was continued until the end. Then, catheterization was performed by detecting the tourniquet by the emergency department nurse. Upon completion of the catheterization procedure, VRG was removed from the procedure area by the researcher. This process took an average of 5 minutes. After the procedure was completed, the pain and satisfaction status of the patients were scored on the VAS by the same nurse.

    Other: Virtual Reality Glasses

  • Experimental
    Thermomechanical Stimulation Device (Buzzy ®) Group

    1 minute before starting the catheterization procedure in this group, a cold and vibration application was placed in the operation area by the researcher using the apparatus of the Buzzy ® device and started. The procedure was performed after evaluating the vein and determining the appropriate right or left arm. At the end of this time, the Buzzy ® has been shifted approximately 5 cm above the processing zone. Then, catheterization was performed. Upon completion of the catheterization procedure, Buzzy ® was removed from the procedure area by the researcher. This process took an average of 4 minutes. After the procedure was completed, the pain and satisfaction status of the patients were scored on the VAS by the same nurse.

    Other: Thermomechanical Stimulation Device

  • No intervention
    Control group

    Peripheral intravenous catheterization was performed by the same emergency department nurse in accordance with the procedure. The process took an average of 3 minutes. There was no application to the patients in the control group except for the standard procedure. After the procedure was completed, the pain and satisfaction status of the patients were scored on the VAS by the same nurse.

Interventions

  • OtherVirtual Reality Glasses

    Group 1

    Also known as: VRG

  • OtherThermomechanical Stimulation Device

    Group 2

    Also known as: Buzzy

06

What researchers measure

Primary outcomes

  1. Pain of the patient during the peripheral intravenous catheterization

    In the study, Visual Analog Scale (VAS) was used to evaluate the pain of the patients. There is a 10 cm ruler on this scale. Patients were asked to rate the pain felt during the procedure on a 10 cm ruler. This scoring was done with a number between 1 and 10. The patient gave a score of "0" if he does not feel pain and "10" if he feels unbearable pain. After the completion of the procedure, the patients were asked to rate the pain they felt during catheterization on a visual comparison scale. At the end of the research, the scale results will be compared and evaluated for all three groups.

    Time frame: 6 month

  2. Satisfaction of the patients about intervention during the peripheral intravenous catheterization

    In the study, another visual comparison scale was used to determine the satisfaction levels of the patients regarding the application to be made. After the completion of the procedure, the patients were asked to rate their satisfaction with the procedure on the Visual Analog Scale (VAS). The scale was scored between 1 and 10, "0" was evaluated as ''I am not satisfied at all'', "10" was evaluated as ''I am very satisfied''. At the end of the research, the scale results will be compared and evaluated in three groups.

    Time frame: 6 month

07

Study locations

1 site
  • Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Nursing
    Ankara, Cubuk 06010, Turkey (Türkiye)
08

References and documents

Publications

  • Serin ZS, Kazan EE. The Effect of Using Thermomechanical Stimulation and Virtual Reality Glasses During Peripheral Intravenous Catheterization on Pain and Patient Satisfaction: A Randomized Controlled Trial. J Emerg Nurs. 2025 Sep;51(5):925-935. doi: 10.1016/j.jen.2025.04.005. Epub 2025 May 26. PubMed 40418199 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2021 to primary completion in Apr 2021, 0 months.

Of 1,253 non-industry interventional studies with no phase under Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 0 months is below that.

Counting every sponsor, half of 1,276 studies reached it within 11 months; a quarter within 5 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2022
First posted
Jun 16, 2022
StartActual
Apr 12, 2021
Primary completionActual
Apr 26, 2021
CompletionActual
Feb 6, 2022
Last update
Jun 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05422287
Responsible party
Ebru Erek Kazan (Assist.Prof.Dr., Ankara Yildirim Beyazıt University) — Principal investigator
First posted
Jun 16, 2022
Start date
Apr 12, 2021
Primary completion
Apr 26, 2021
Completion
Feb 6, 2022
Last update
Jun 16, 2022

Study contacts

Züleyha Setenay Serin, MsN
principal investigator · Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Nursing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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