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CatheterizationNCT05422287

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

A study testing Virtual Reality Glasses and Thermomechanical Stimulation Device in people with Catheterization, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Catheterization
What is being tested?
Virtual Reality Glasses and Thermomechanical Stimulation Device
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 Apr 2021to 6 Feb 2022
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Nursing

    Ankara, Cubuk, 06010

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Using a Thermomechanical Stimulation Device and Virtual Reality Glasses During Peripheral Intravenous Catheter Administration on Pain and Patient Satisfaction in Adult Patients

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.

Conditions
Catheterization
Being tested
Virtual Reality Glasses, Thermomechanical Stimulation Device
Keywords
Nursing, pain, patient satisfaction, peripheral intravenous catheterization, thermomechanical stimulation, virtual reality
Medical subject headings
Pain, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality GlassesOther

    Also called VRG

    Group 1

  • Thermomechanical Stimulation DeviceOther

    Also called Buzzy

    Group 2

Study groups in NCT05422287
Study groupRoleWhat they receive
Virtual Reality Glasses (VRG) GroupExperimentalThe 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.
Receives: Other: Virtual Reality Glasses
Thermomechanical Stimulation Device (Buzzy ®) GroupExperimental1 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.
Receives: Other: Thermomechanical Stimulation Device
Control groupNo interventionPeripheral 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2022
  2. Study start12 Apr 2021
  3. Primary completion26 Apr 2021
  4. Study completion6 Feb 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05422287
Sponsor's protocol ID
2021/76
Status last verified
Jun 2022
First submitted
14 Jun 2022
Last updated
16 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Glasses and Thermomechanical Stimulation Device in people with Catheterization, run by Ankara Yildirim Beyazıt 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 12 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 16 Jun 2022. 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. 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 of the patient during the peripheral intravenous catheterization (time frame: 6 month). 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?

On the ClinicalTrials.gov record for NCT05422287, which also lists 1 linked publication.

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 16 Jun 2022.

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