Primary Immunodeficiency Diseases (PID)NCT07004803
Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency
A study testing Virtual reality video watching and Tablet video watching in people with Primary Immunodeficiency Diseases (PID), run by Dr. Hatice Dönmez at 1 site in Turkey (Türkiye).
Trial summary
In this study, it is aimed to investigate the effect of virtual reality and tablet video viewing intervention on pain and fear levels and vital signs of children during peripheral venous catheter placement for intravenous immunoglobulin (IVIG) administration. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Primary Immunodeficiency Diseases (PID)
- What is being tested?
- Virtual reality video watching and Tablet video watching
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 15 Jun 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between the ages of 4-11
- Being followed up with the diagnosis of Primary Immunodeficiency for at least 6 months
- To accept participation in the study voluntarily
- No additional chronic disease other than primary immunodeficiency
Who cannot join
- Organ failure is present
- Having a mental deficiency
- Having a disability to use VR Glasses
- Children with fever (|>37.5 C0)
- Children with severe dehydration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency Applying Intravenous Immunoglobulin During Intravenous Access: A Crossover Randomized Controlled Trial
In this study, it is aimed to investigate the effect of virtual reality and tablet video viewing intervention on pain and fear levels and vital signs of children during peripheral venous catheter placement for intravenous immunoglobulin (IVIG) administration.
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Being tested
- Virtual reality video watching, Tablet video watching
- Keywords
- Children, Virtual Reality, Primary Immunodeficiency, Nursing care, Administration, Intravenous
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality video watchingOther
The children in the VR experimental group of the study will be subjected to the clinic's routine venipuncture procedure and the video-watching intervention with virtual reality headset. Routine care includes informing the child and parents about the procedure and questions that strengthen communication and distract attention. For example, it consists of questions such as 'How old are you?', 'Do you go to school?', 'Can you tell me the name of your favorite friend?'. Virtual reality headset will be introduced to the child before the procedure and information about how to use them will be given. After the measurements, intravenous access will be started. During the procedure, children will be shown a roller coaster video on virtual reality headset. The video-viewing process will be started 2 minutes before the venipuncture procedure. The video viewing time is planned to last an average of 4 minutes. Measurements were made during and after the procedure
Tablet video watchingOther
The children in the experimental group of the study will be subjected to the clinic's routine venipuncture procedure and the video-watching intervention with Tablet. Routine care includes informing the child and parents about the procedure and questions that strengthen communication and distract attention. For example, it consists of questions such as 'How old are you?', 'Do you go to school?', 'Can you tell me the name of your favorite friend?'. Tablet will be introduced to the child before the procedure and information about how to use them will be given. After the measurements, intravenous access will be started. During the procedure, children will be shown a roller coaster video on tablet. The video-viewing process will be started 2 minutes before the venipuncture procedure. The video viewing time is planned to last an average of 4 minutes. Measurements were made during and after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality group | Experimental | Not described Receives: Other: Virtual reality video watching |
| Tablet group | Active comparator | Not described Receives: Other: Tablet video watching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Fear Scale
Measured: 5 minutes
Wong-Baker Pain Scale
Measured: 5 minutes
Children's Emotional Manifestation Scale
Measured: 5 minutes
Secondary outcomes (1)
Vital Signs
Pulse, oxygen saturation
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start15 Sep 2024
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency Diseases (PID)Studies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Hatice Dönmez
- Sponsor type
- University, hospital or other
- Collaborators
- Karamanoğlu Mehmetbey University
- Responsible party
- Sponsor-investigator, Dr. Hatice Dönmez, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004803
- Sponsor's protocol ID
- KMU-SBF-HD-01
- Other IDs
- 16-M-24
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency Applying Intravenous Immunoglobulin During Intravenous Access: A Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07004803
- Acronym / sponsor ID
- KMU-SBF-HD-01
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Keywords
- Children, Virtual Reality, Primary Immunodeficiency, Nursing care, Administration, Intravenous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Dr. Hatice DönmezUniversity, hospital or other
- Collaborators
- Karamanoğlu Mehmetbey University
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 4 Jun 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.
In this study, it is aimed to investigate the effect of virtual reality and tablet video viewing intervention on pain and fear levels and vital signs of children during peripheral venous catheter placement for intravenous immunoglobulin (IVIG) administration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality group | Experimental | Other: Virtual reality video watching |
| Tablet group | Active comparator | Other: Tablet video watching |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being between the ages of 4-11
- Being followed up with the diagnosis of Primary Immunodeficiency for at least 6 months
- To accept participation in the study voluntarily
- No additional chronic disease other than primary immunodeficiency
Key exclusion criteria (5 listed)
- Organ failure is present
- Having a mental deficiency
- Having a disability to use VR Glasses
- Children with fever (|>37.5 C0)
- Children with severe dehydration
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 video watchingThe children in the VR experimental group of the study will be subjected to the clinic's routine venipuncture procedure and the video-watching intervention with virtual reality headset. Routine care includes informing the child and parents about the procedure and questions that strengthen communication and distract attention. For example, it consists of questions such as 'How old are you?', 'Do you go to school?', 'Can you tell me the name of your favorite friend?'. Virtual reality headset will be introduced to the child before the procedure and information about how to use them will be given. After the measurements, intravenous access will be started. During the procedure, children will be shown a roller coaster video on virtual reality headset. The video-viewing process will be started 2 minutes before the venipuncture procedure. The video viewing time is planned to last an average of 4 minutes. Measurements were made during and after the procedure | Other | Virtual reality group |
| Tablet video watchingThe children in the experimental group of the study will be subjected to the clinic's routine venipuncture procedure and the video-watching intervention with Tablet. Routine care includes informing the child and parents about the procedure and questions that strengthen communication and distract attention. For example, it consists of questions such as 'How old are you?', 'Do you go to school?', 'Can you tell me the name of your favorite friend?'. Tablet will be introduced to the child before the procedure and information about how to use them will be given. After the measurements, intravenous access will be started. During the procedure, children will be shown a roller coaster video on tablet. The video-viewing process will be started 2 minutes before the venipuncture procedure. The video viewing time is planned to last an average of 4 minutes. Measurements were made during and after the procedure. | Other | Tablet group |
Primary outcome
Children's Fear Scale
Time frame: 5 minutes
Wong-Baker Pain Scale
Time frame: 5 minutes
Children's Emotional Manifestation Scale
Time frame: 5 minutes
1 secondary outcome
Vital Signs
Time frame: 5 minutes
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 9 Jun 2026.
- 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.
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 Virtual reality video watching and Tablet video watching in people with Primary Immunodeficiency Diseases (PID), run by Dr. Hatice Dönmez 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 4 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 9 Jun 2026. 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?
Children's Fear Scale (time frame: 5 minutes). 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 9 Jun 2026.