- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06835712
Virtual Reality and Guided Imagery to Reduce Procedural Pain
April 28, 2025 updated by: Derya Uzelli, Izmir Katip Celebi University
Virtual Reality and Guided Imagery to Reduce Pain During Peripheral Intravenous Catheterization Procedure in Adults: A Randomized Controlled Trial
Aim: The aim of the present study was to examine the effect of virtual reality and guided imagery to reduce pain during peripheral intravenous catheterization procedures in adults.Methods: The study will include 90 adults who were randomly selected between February and March 2025.
One application group (n=30) will receive a virtual reality glasses application; the other application group (n=30) will receive a guided imagery application.
The applications to the site of the peripheral intravenous catheterization will last two minutes.
The control group (n=30) will receive the standard peripheral intravenous catheterization application procedure.
The groups' level of pain during catheterization will be assessed using a visual analog scale.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cigli
-
Izmir, Cigli, Turkey, 35640
- Izmir Katip Çelebi University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being in accordance with time and place
- Being in no sensory problems
- Being aged between 18 and 65 years
- Being able to evaluate the visual analog scale correctly
- Participating voluntarily in the research.
Exclusion Criteria:
- Not participating voluntarily in the research
- Not fitting the inclusion criteria of the research
- Having a vision or hearing problem
- Having any illness which could affect pain perception, such as sensorymotor disorder, diabetes, peripheral vascular diseases or peripheral neuropathy
- Having phlebitis, scar tissue, dermatitis, an incision or findings of infection at the place where the intervention was to be performed
- Having taken an analgesic (within the previous six hours) or an anesthetic agent before the peripheral intravenous catheterization procedure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The virtual reality group
During peripheral intravenous catheterization, virtual reality headset (Oculus Go) will be worn.
Because the headset is reusable, attention will be paid to disinfecting them before and after each use.
|
Patients in this group will be played an audio clip that helps them imagine walking on a beach and gives instructions during the walk until the procedure is completed, using an MP3 player and headphones.
The audio clip aims to activate the imagination of patients by allowing them to use their senses.
For example, the temperature of the sun (feeling), the texture of the sand (touching), the color of the sea (seeing), the sound of the waves (hearing), and the smell of the sea (smell) are some examples of this.
The audio clip will be voiced by a professional voice artist with good diction.
It is planned that the audio clip will be played for approximately 2-3 minutes during the application.
During this time, patients will be allowed to close their eyes and take a comfortable position.
The headphones of the MP3 player will be disinfected after each application and used on the other patient.
|
|
Experimental: The guided imagery group
During peripheral intravenous catheterization, an audio clip Mp3 player and headphones will be worn.
Since these headphones are reusable, they will be disinfected before and after each use.
|
During the PIK application, 3D visual and audio videos of the beach will be played with an Oculus Go brand virtual reality (VR) headset until the procedure is completed.
The video that starts at the beginning of the procedure is planned to last approximately 2-3 minutes during the application.
During this time, patients will be asked to close their eyes and take a comfortable position.
The VR headset will be disinfected after each application and used on the other patient.
|
|
Experimental: The control group
No intervention will perform on the control group before the peripheral intravenous catheterization procedure, and the standard peripheral intravenous catheterization procedure will perform.
|
Patients in this group will be played an audio clip that helps them imagine walking on a beach and gives instructions during the walk until the procedure is completed, using an MP3 player and headphones.
The audio clip aims to activate the imagination of patients by allowing them to use their senses.
For example, the temperature of the sun (feeling), the texture of the sand (touching), the color of the sea (seeing), the sound of the waves (hearing), and the smell of the sea (smell) are some examples of this.
The audio clip will be voiced by a professional voice artist with good diction.
It is planned that the audio clip will be played for approximately 2-3 minutes during the application.
During this time, patients will be allowed to close their eyes and take a comfortable position.
The headphones of the MP3 player will be disinfected after each application and used on the other patient.
During the PIK application, 3D visual and audio videos of the beach will be played with an Oculus Go brand virtual reality (VR) headset until the procedure is completed.
The video that starts at the beginning of the procedure is planned to last approximately 2-3 minutes during the application.
During this time, patients will be asked to close their eyes and take a comfortable position.
The VR headset will be disinfected after each application and used on the other patient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
procedure duration in sec
Time Frame: during the intervention/procedure
|
In the stages of the peripheral intravenous catheterization intervention of individuals in the application and control groups, a chronometer will start immediately after an automatic tourniquet is attached to the patient's arm.
After catheterization was completed successfully, the chronometer was stopped, and the procedure duration was recorded in the form of seconds on the data collection form.
|
during the intervention/procedure
|
|
pain intensity in mm
Time Frame: during the intervention/procedure
|
A 10-cm vertical VAS was used to evaluate the severity of pain felt by the individuals during the procedure.
The lowest score that can be obtained from the scale is 0 and the highest score is 10 cm (100 mm).
Pain severity was evaluated in millimeters
|
during the intervention/procedure
|
|
procedure satisfaction in mm
Time Frame: during the intervention/procedure
|
A scale between 1 and 10 will be used to evaluate the patients' satisfaction levels with the procedure.
"1" on this scale indicates the least satisfaction level, and "10" indicates the highest satisfaction level.
Patients will be asked to mark their level.
|
during the intervention/procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2025
Primary Completion (Actual)
March 20, 2025
Study Completion (Actual)
March 30, 2025
Study Registration Dates
First Submitted
February 8, 2025
First Submitted That Met QC Criteria
February 18, 2025
First Posted (Actual)
February 19, 2025
Study Record Updates
Last Update Posted (Actual)
May 1, 2025
Last Update Submitted That Met QC Criteria
April 28, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 0040
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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