Pain ManagementNCT06835712
Virtual Reality and Guided Imagery to Reduce Procedural Pain
A study testing The virtual reality and The guided imagery in people with Pain Management and Virtual Reality Pain Distraction, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Virtual Reality Pain Distraction, Guided Imagery
- What is being tested?
- The virtual reality and The guided imagery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2025to 30 Mar 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Celebi University
Izmir, Cigli, 35640
About this study
Official title: 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.
- Conditions
- Pain Management, Virtual Reality Pain Distraction, Guided Imagery, Peripheral Intravenous Catheterization Application
- Being tested
- The virtual reality, The guided imagery
- Keywords
- virtual reality, guided imagery, pain management, peripheral intravenous catheterization
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The virtual realityOther
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.
The guided imageryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The virtual reality group | Experimental | 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. Receives: Other: The guided imagery |
| The guided imagery group | Experimental | 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. Receives: Other: The virtual reality |
| The control group | Experimental | No intervention will perform on the control group before the peripheral intravenous catheterization procedure, and the standard peripheral intravenous catheterization procedure will perform. Receives: Other: The virtual reality; Other: The guided imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedure duration in sec
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.
Measured: during the intervention/procedure
pain intensity in mm
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
Measured: during the intervention/procedure
procedure satisfaction in mm
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.
Measured: during the intervention/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start20 Feb 2025
- Primary completion20 Mar 2025
- Study completion30 Mar 2025
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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Uzelli, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835712
- Sponsor's protocol ID
- 0040
- Status last verified
- Apr 2025
- First submitted
- 8 Feb 2025
- Last updated
- 1 May 2025
- 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 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and Guided Imagery to Reduce Pain During Peripheral Intravenous Catheterization Procedure in Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06835712
- Acronym / sponsor ID
- 0040
- Conditions
- Pain Management, Virtual Reality Pain Distraction, Guided Imagery, Peripheral Intravenous Catheterization Application
- Keywords
- virtual reality, guided imagery, pain management, peripheral intravenous catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 19 Feb 2025 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The virtual reality group | Experimental | Other: The guided imageryDuring 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. |
| The guided imagery group | Experimental | Other: The virtual realityDuring 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. |
| The control group | Experimental | Other: The virtual reality, Other: The guided imageryNo intervention will perform on the control group before the peripheral intravenous catheterization procedure, and the standard peripheral intravenous catheterization procedure will perform. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| The virtual realityDuring 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. | Other | The control group, The guided imagery group |
| The guided imageryPatients 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. | Other | The control group, The virtual reality group |
Primary outcome
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.
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
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.
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 1 May 2025.
- Individual participant dataSharing planned: Undecided
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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 The virtual reality and The guided imagery in people with Pain Management and Virtual Reality Pain Distraction, run by Izmir Katip Celebi 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 5 inclusion and 6 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 1 May 2025. 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?
procedure duration in sec (time frame: during the intervention/procedure). The study lists 3 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 1 May 2025.