PainNCT05769647
Effect of Two Different Methods on Pain and Anxiety
A study testing Virtual Reality Glasses and Stress Ball in people with Pain, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of virtual reality glasses and ball squeezing method used during peripheral intravenous catheter placement on pain and anxiety.The hypotheses of this research are that virtual reality glasses and a stress ball reduces pain and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Virtual Reality Glasses and Stress Ball
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 4 Aug 2023
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Admission to the General Surgery clinic.
- No verbal, perceptual and visual communication problems,
- Being between 18 - 65 years old,
- Being literate,
- Volunteer to participate in the research,
- Not using drugs that will create a chronic analgesic effect,
Show all 10Show fewer
- Absence of chronic or acute pain,
- No intervention in the last month in the vein where an IV catheter was placed.
- The absence of scar tissue and infection in the areas to be used for IV catheter placement,
- It was determined as not having a disease (such as neuropathy) that would cause problems in feeling pain.
Who cannot join
- The individual's desire to leave the study,
- Inability to perform the ball squeezing motion,
- Feeling unwell during IV catheter placement (such as dizziness, palpitations),
- During use of VR, the patient experiences symptoms such as nausea and dizziness,
- Using sedatives or alcohol,
- Termination criteria
- Failure of PIV catheter placement,
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Necmettin Erbakan University
Konya, 42040
Turkey, Necmettin Erbakan University
Konya, 42040
About this study
Official title: Effect of Two Different Methods Applied During Peripheral Intravenous Catheter Placement on Pain and Anxiety
The aim of this study is to determine the effect of virtual reality glasses and ball squeezing method used during peripheral intravenous catheter placement on pain and anxiety.The hypotheses of this research are that virtual reality glasses and a stress ball reduces pain and anxiety.
Read the detailed description
This study was designed as a pretest-posttest regular parallel group, randomized controlled experimental. The research will be carried out in the general surgery clinic of Necmettin Erbakan University Meram Medical Faculty Hospital. Patients will be randomly assigned to three groups: ball squeezing (37), virtual reality glasses (37) and control group (37). For Virtual Reality Glasses Group: The video containing the nature walk will be watched by virtual reality. 3 minutes after the individual starts watching the video, the IV catheter insertion attempt will be performed while continuing to watch the video. For Ball Squeezing Group: Patients will be given a ball and instructed to tighten and loosen with their free hand during intravenöz catheter placement. The intravenöz catheter insertion attempt will be made while the patient continues to squeeze the ball. For Control Group: No application will be made during intravenous catheter placement in the control group.The primary outcome of this study was to determine the patients' pain scores during the peripheral venous cannula insertion process.The secondary outcomes of the study were to determine the patients' anxiety levels.
- Conditions
- Pain
- Being tested
- Virtual Reality Glasses, Stress Ball
- Keywords
- Peripheral Intravenous Catheter Insertion, Pain, Anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GlassesDevice
3 minutes after the individual starts watching the video, the IV catheter insertion attempt will be performed while continuing to watch the video.
Stress BallDevice
Patients will be given a ball and instructed to tighten and loosen with their free hand during IVC placement. The patient will continue to squeeze the ball throughout the IV catheter insertion attempt.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Glasses Group | Experimental | * "Volunteer Information and Approval Form" will be filled.
* Physician request, the name and surname of the individual will be checked.
* Patient Information Form and State Anxiety Scale will be filled.
* The video containing the nature walk will be watched by virtual reality. 3 minutes after the individual starts watching the video, the IV catheter insertion attempt will be performed while continuing to watch the video.
* Visual Pain Scale and State Anxiety Scale will be filled within one minute after intravenous catheter placement is completed. Receives: Device: Virtual Reality Glasses |
| Ball Squeezing Group | Experimental | * "Volunteer Information and Approval Form" will be filled.
* Physician request, the name and surname of the individual will be checked.
* Patient Information Form and State Anxiety Scale will be filled.
* Patients will be given a ball and instructed to tighten and loosen with their free hand during IVC placement. The IV catheter insertion attempt will be made while the patient continues to squeeze the ball.
* Visual Pain Scale and State Anxiety Scale will be filled within one minute after intravenous catheter placement is completed. Receives: Device: Stress Ball |
| Control Group: | No intervention | * "Volunteer Information and Approval Form" will be filled. * Physician request, the name and surname of the individual will be checked. * Patient Information Form and State Anxiety Scale will be filled. * An intravenous catheter will be placed. * Visual Pain Scale and State Anxiety Scale will be filled within one minute after intravenous catheter placement is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluated using the Visual Pain Scale
The Visual Pain Scale is mostly a 10 cm/100 mm long horizontal or vertical line starting with "No pain" and ending with "Unbearable pain". While measuring, there is no pain at one end, very severe or unbearable pain is written on the other end, and the patient marks his or her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
Measured: It will be applied within 1 minute after the virtual reality reality glasses and ball squeezing processes.
Secondary outcomes (1)
Anxiety evaluated using the State Anxiety Scale
In the State Anxiety Inventory, the individual evaluates how he or she feels "at the moment" and according to the severity of the emotions or behaviors expressed in the items (1) "never", (2) "a little", (3) "a lot" and (4) "a lot". are asked to choose one of the statements "completely". The highest score of 4 is given for choosing the phrase "completely", and the lowest score is 1 for choosing the phrase "not at all". The lowest total score that can be obtained from the State Anxiety Scale is 20, and the highest total score is 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.
Measured: It will be applied before and afte within 1 minute after the virtual reality reality glasses and ball squeezing processes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start15 Jul 2023
- Primary completion4 Aug 2023
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil SU, Necmettin Erbakan University
- Investigators
- Serpil SU, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769647
- Sponsor's protocol ID
- Nec EU
- Status last verified
- Dec 2023
- First submitted
- 3 Mar 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Methods Applied During Peripheral Intravenous Catheter Placement on Pain and Anxiety
- ClinicalTrials.gov ID
- NCT05769647
- Acronym / sponsor ID
- Nec EU
- Conditions
- Pain
- Keywords
- Peripheral Intravenous Catheter Insertion, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 15 Mar 2023 (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.
The aim of this study is to determine the effect of virtual reality glasses and ball squeezing method used during peripheral intravenous catheter placement on pain and anxiety.The hypotheses of this research are that virtual reality glasses and a stress ball reduces pain and anxiety.
Detailed description
This study was designed as a pretest-posttest regular parallel group, randomized controlled experimental. The research will be carried out in the general surgery clinic of Necmettin Erbakan University Meram Medical Faculty Hospital. Patients will be randomly assigned to three groups: ball squeezing (37), virtual reality glasses (37) and control group (37). For Virtual Reality Glasses Group: The video containing the nature walk will be watched by virtual reality. 3 minutes after the individual starts watching the video, the IV catheter insertion attempt will be performed while continuing to watch the video. For Ball Squeezing Group: Patients will be given a ball and instructed to tighten and loosen with their free hand during intravenöz catheter placement. The intravenöz catheter insertion attempt will be made while the patient continues to squeeze the ball. For Control Group: No application will be made during intravenous catheter placement in the control group.The primary outcome of this study was to determine the patients' pain scores during the peripheral venous cannula insertion process.The secondary outcomes of the study were to determine the patients' anxiety levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Glasses Group | Experimental | Device: Virtual Reality Glasses* "Volunteer Information and Approval Form" will be filled. * Physician request, the name and surname of the individual will be checked. * Patient Information Form and State Anxiety Scale will be filled. * The video containing the nature walk will be watched by virtual reality. 3 minutes after the individual starts watching the video, the IV catheter insertion attempt will be performed while continuing to watch the video. * Visual Pain Scale and State Anxiety Scale will be filled within one minute after intravenous catheter placement is completed. |
| Ball Squeezing Group | Experimental | Device: Stress Ball* "Volunteer Information and Approval Form" will be filled. * Physician request, the name and surname of the individual will be checked. * Patient Information Form and State Anxiety Scale will be filled. * Patients will be given a ball and instructed to tighten and loosen with their free hand during IVC placement. The IV catheter insertion attempt will be made while the patient continues to squeeze the ball. * Visual Pain Scale and State Anxiety Scale will be filled within one minute after intravenous catheter placement is completed. |
| Control Group: | No intervention | –* "Volunteer Information and Approval Form" will be filled. * Physician request, the name and surname of the individual will be checked. * Patient Information Form and State Anxiety Scale will be filled. * An intravenous catheter will be placed. * Visual Pain Scale and State Anxiety Scale will be filled within one minute after intravenous catheter placement is completed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Admission to the General Surgery clinic.
- No verbal, perceptual and visual communication problems,
- Being between 18 - 65 years old,
- Being literate,
- Volunteer to participate in the research,
Key exclusion criteria (7 listed)
- The individual's desire to leave the study,
- Inability to perform the ball squeezing motion,
- Feeling unwell during IV catheter placement (such as dizziness, palpitations),
- During use of VR, the patient experiences symptoms such as nausea and dizziness,
- Using sedatives or alcohol,
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 |
|---|---|---|
| Virtual Reality Glasses3 minutes after the individual starts watching the video, the IV catheter insertion attempt will be performed while continuing to watch the video. | Device | Virtual Reality Glasses Group |
| Stress BallPatients will be given a ball and instructed to tighten and loosen with their free hand during IVC placement. The patient will continue to squeeze the ball throughout the IV catheter insertion attempt. | Device | Ball Squeezing Group |
Primary outcome
Pain evaluated using the Visual Pain Scale
Time frame: It will be applied within 1 minute after the virtual reality reality glasses and ball squeezing processes.
The Visual Pain Scale is mostly a 10 cm/100 mm long horizontal or vertical line starting with "No pain" and ending with "Unbearable pain". While measuring, there is no pain at one end, very severe or unbearable pain is written on the other end, and the patient marks his or her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
1 secondary outcome
Anxiety evaluated using the State Anxiety Scale
Time frame: It will be applied before and afte within 1 minute after the virtual reality reality glasses and ball squeezing processes.
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 14 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Serpil SU principal investigator
Necmettin Erbakan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Glasses and Stress Ball in people with Pain, run by Necmettin Erbakan University at 2 sites 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 10 inclusion and 7 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 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 evaluated using the Visual Pain Scale (time frame: It will be applied within 1 minute after the virtual reality reality glasses and ball squeezing processes.). 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 14 Feb 2024.