PatientNCT07505225
Effects of Interventions on Child's Pain, Physiological, and Psychological Responses During Venous Catheterization
A study testing Virtual Reality Headset Group (VRHG) and On-screen Video Viewing Group (OVVG) in people with Patient and Child, run by Ali Yıldız at 1 site in Turkey (Türkiye).
Trial summary
The study aimed to determine the effects of virtual reality headsets and on-screen video viewing methods on physiological parameters (heart rate, oxygen saturation, and respiration), procedural pain, fear, and emotional reactions during peripheral venous catheter placement in children aged 7-12. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- What is being tested?
- Virtual Reality Headset Group (VRHG) and On-screen Video Viewing Group (OVVG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2025to 18 Jul 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child should be monitored at the hospital for a minimum of 30 minutes and a maximum of 6 hours during the planned training.
- The child should be able to understand and speak Turkish fluently.
- Child must be aged 7-12 years old.
- Prior to the assessment process, the child's Wong-Baker Facial Expression Assessment Scale score must be 0.
- There should be no condition in the hand and arm area that would prevent the establishment of planned peripheral venous access.
Who cannot join
- The child or parent does not wish to participate in the study
- The child has a history of sedative or narcotic substance use within the last 24 hours
- The child has received analgesia within the last 6 hours
- The child has a visual health problem
- The child has a hearing health problem
- The child has a neurological disease that may be triggered by sight and sound
Show all 13Show fewer
- The child has a history of syncope during invasive procedures (blood sampling, intravenous access, etc)
- The child has loss of sensation or tissue in the extremities (e.g., plaster casts) that would prevent intravenous access
- The child has a wound/trauma to the scalp or any part of the head
- The child has a health problem requiring isolation
- The child or parent expressing a desire to withdraw from the study at any stage of the research.
- The child experiencing health problems during the procedure (syncope, seizures, etc.).
- Initiating any medication or fluid treatment within 2 minutes of intravenous access (until the final test measurement).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of VR Glasses and Video Screen Viewing Attempts on Physiological Parameters, Pain, Fear, and Emotional Responses During Peripheral Venous Catheter Placement for Child
The study aimed to determine the effects of virtual reality headsets and on-screen video viewing methods on physiological parameters (heart rate, oxygen saturation, and respiration), procedural pain, fear, and emotional reactions during peripheral venous catheter placement in children aged 7-12.
A parallel-group, repeated-measurement (pretest, interim, and post-test) randomized controlled trial was conducted between January 18 and June 19, 2025, with children aged 7-12 (Virtual Reality Headset Group-VRHG=22, On-screen Video Viewing Group-OVVG=22, Control Group-CG=22) who were followed in the paediatric emergency department of a university hospital in Konya. The data collection tools in the study were: Information Form, Physiological Parameters Assessment Form, Wong-Baker FACES Pain Rating Scale (WB-FPRS), Children's Fear Scale (CFS), and Children's Emotional Manifestation Scale (CEMS) were used. Two minutes before the peripheral venous catheter placement procedure, the "Under the Sea" video was shown to VRHG and OVVG, and it continued for two minutes after the procedure. Routine hospital practice was continued for the CG. Data were entered into SPSS-25.0, and descriptive statistics, chi-square test, Kruskal-Wallis, one-way ANOVA, one-way ANOVA for repeated measures, and two-way ANOVA were used for data analysis. Statistical significance was set at 0.05.
Read the detailed description
Pain is a subjective condition that varies from person to person. In the literature, pain is defined as a distressing experience expressed/shown by the individual. Pain is a subjective experience; physiologically, the perception of pain occurs in four stages (transduction, transmission, modulation, and perception). Pain can be grouped in different ways (according to neurophysiology, duration, etiology, and region).
Another concept included in the classification of pain today is procedural pain.
Procedural pain is pain that occurs due to invasive procedures or other interventions resulting from medical necessities (diagnosis, treatment, care processes, etc.). In the literature, decreased communication, increased dissatisfaction with care, and significant changes in physiological parameters are reported as occurring due to procedural pain. Procedural pain is important in all age groups, but it is a condition that requires particular attention in pediatric patients.
The response to procedural pain in children involves a complex interplay of individual and contextual factors, including age, developmental level, medical history, and parental involvement. Children may exhibit various responses to pain: physical (e.g., aggressive behavior, crying), physiological (e.g., increased heart rate and respiration), and psychological (e.g., anxiety, fear). Effective management of procedural pain has become increasingly important, encompassing both pharmacological and non-pharmacological interventions. Non-pharmacological methods, such as distraction techniques (e.g., video viewing, music therapy), have gained traction in pediatric care, particularly during invasive procedures. Despite the promising findings in the literature regarding pain management, there remains a gap in comprehensive studies addressing the role of distractions and the potential negative emotional experiences associated with procedural interventions, such as anxiety during peripheral venous catheter placement. Additionally, recent research explores the use of virtual reality and video viewing methods to assess procedural pain and anxiety, utilizing physiological monitoring without incurring costs.
The aim of this randomized controlled experimental study is to investigate the effects of virtual reality glasses and screen-based video viewing methods on physiological parameters (pulse, oxygen saturation, and respiration), procedural pain, fear, and emotional responses in children aged 7-12 years during peripheral venous catheter placement. This research will guide nursing approaches in managing pain, fear, and emotional responses that may occur in children during invasive procedures by examining the effect of video viewing with two different methods (screen-based and virtual reality glasses) from current approaches in procedural pain management. Managing physiological and psychological responses to procedural pain in children will affect satisfaction with nursing care in the short term, while, in the long term, it will increase the applicability of child-centered and atraumatic care today.
- Being tested
- Virtual Reality Headset Group (VRHG), On-screen Video Viewing Group (OVVG), Control Group (CG)
- Keywords
- patient, child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Headset Group (VRHG)Other
The child and their family in this group were given information about virtual reality goggles, infection control materials (a disposable surgical cap and a virtual reality goggle pad), a saturation device, and an underwater video (https://www.youtube.com/watch?v=XEkUy7a8vfI). The headset was disinfected before the procedure. The virtual reality goggles were adjusted to fit the child's head, and the lens was adjusted according to the child's feedback to ensure video clarity. The video began 2 minutes before the peripheral venous catheter placement procedure. The peripheral venous catheter placement was performed by the ward head nurse. After the peripheral venous catheter was placed, the child watched the video for another two minutes. The child's total video viewing time was 4 minutes. The headset was disinfected after the procedure.
On-screen Video Viewing Group (OVVG)Other
The materials to be used for the child and their family in this group, including a phone screen, screen holder, headphones, infection control materials (ear cap), a saturation device, and a submarine video (https://www.youtube.com/watch?v=XEkUy7a8vfI), were introduced.Before the procedure, the phone screen, screen holder, and headphones were disinfected. After the phone screen was placed in the holder, it was placed on a table 50 cm away from the child's eye level in the area where the procedure would be performed. The child's ability to see the screen properly was assessed. Based on the child's feedback, the table was set to 45-55 cm. The headphones to be used in the procedure were placed appropriately on the child's head and ears. The headphones' volume was adjusted to the appropriate level for the child based on the child's feedback. The video began 2 minutes before the peripheral venous catheter placement procedure. The peripheral venous catheter placement procedure was performed
Control Group (CG)Other
In the pediatric emergency department, no interventions beyond standard service routines for peripheral venous access were performed; however, for this study, CG components and a saturation device were introduced. Peripheral venous placement was performed by the registered service supervisor.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Headset Group (VRHG) | Experimental | The use of virtual reality (VR) headsets to present audiovisual content to children. Receives: Other: Virtual Reality Headset Group (VRHG) |
| On-screen Video Viewing Group (OVVG) | Experimental | The use of on-screen audiovisual content for children Receives: Other: On-screen Video Viewing Group (OVVG) |
| Control Group (CG) | Other | No interventions beyond standard service routines for peripheral venous access were performed. Receives: Other: Control Group (CG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological Parameters Assessment Form
This form was designed to measure physiological parameters affected by pain (pulse rate, respiratory rate, and oxygen saturation). Blood pressure and fever parameters, which are not affected by short-term procedural pain as mentioned in the literature, were not included in this form. The aim of the study is to ensure that the child's physiological parameters remain within normal limits in the intervention groups.
Measured: Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)
Wong-Baker Faces Pain Raiting Scale (WB-FPRS)
Developed by Wong and Connie Morain Baker in 1981 and updated in 1983, the scale is used to measure pain in children aged 3-18 years. The scale includes five different facial expressions, each corresponding to a number between 0 and 10. Higher numbers indicate higher pain levels. In this study, it was expected that the intervention groups would have lower pain scores.
Measured: Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)
Children's Fear Scale (CFS)
CFS, developed by McMurtry et al. (2011), is a visual scale containing five different facial expressions (hairless, gender-informed) and a rapid scale ranging from 0 (neutral facial expression) to 4 (extremely fearful-anxious facial expression) for each facial expression. A higher score on the scale indicates a greater capacity for fear in adolescents. The study expects the intervention groups to have lower CFS scores.
Measured: Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)
Children's Emotional Manifestation Scale (CEMS)
Li and Lopez (2005) developed a comprehensive five-section assessment scale, comprising facial expression, voice acting, activity, interaction, and cooperation, scored from 1 to 5. In this context, scores on the Critical Disorder of Emotional State (CDVD) range from 5 (lowest) to 25 (highest), with lower scores indicating a heightened negative emotional state. Results indicated that intervention groups showed significantly lower mean scale scores.
Measured: Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start18 Jan 2025
- Primary completion19 Jun 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PatientStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ali Yıldız
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Yıldız, Selcuk University
- Investigators
- Sevil Özkan, Assist Prof, Study director, Selcuk University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505225
- Sponsor's protocol ID
- Ethic approval number:2024/75
- Status last verified
- Apr 2026
- First submitted
- 23 Aug 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If necessary, researchers will be contacted, and the sharing status will be reviewed again based on the study's type and purpose.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of VR Glasses and Video Screen Viewing Attempts on Physiological Parameters, Pain, Fear, and Emotional Responses During Peripheral Venous Catheter Placement for Child
- ClinicalTrials.gov ID
- NCT07505225
- Acronym / sponsor ID
- Ethic approval number:2024/75
- Keywords
- patient, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ali YıldızUniversity, hospital or other
- Study start
- 18 Jan 2025 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 1 Apr 2026 (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 study aimed to determine the effects of virtual reality headsets and on-screen video viewing methods on physiological parameters (heart rate, oxygen saturation, and respiration), procedural pain, fear, and emotional reactions during peripheral venous catheter placement in children aged 7-12.
A parallel-group, repeated-measurement (pretest, interim, and post-test) randomized controlled trial was conducted between January 18 and June 19, 2025, with children aged 7-12 (Virtual Reality Headset Group-VRHG=22, On-screen Video Viewing Group-OVVG=22, Control Group-CG=22) who were followed in the paediatric emergency department of a university hospital in Konya. The data collection tools in the study were: Information Form, Physiological Parameters Assessment Form, Wong-Baker FACES Pain Rating Scale (WB-FPRS), Children's Fear Scale (CFS), and Children's Emotional Manifestation Scale (CEMS) were used. Two minutes before the peripheral venous catheter placement procedure, the "Under the Sea" video was shown to VRHG and OVVG, and it continued for two minutes after the procedure. Routine hospital practice was continued for the CG. Data were entered into SPSS-25.0, and descriptive statistics, chi-square test, Kruskal-Wallis, one-way ANOVA, one-way ANOVA for repeated measures, and two-way ANOVA were used for data analysis. Statistical significance was set at 0.05.
Detailed description
Pain is a subjective condition that varies from person to person. In the literature, pain is defined as a distressing experience expressed/shown by the individual. Pain is a subjective experience; physiologically, the perception of pain occurs in four stages (transduction, transmission, modulation, and perception). Pain can be grouped in different ways (according to neurophysiology, duration, etiology, and region).
Another concept included in the classification of pain today is procedural pain.
Procedural pain is pain that occurs due to invasive procedures or other interventions resulting from medical necessities (diagnosis, treatment, care processes, etc.). In the literature, decreased communication, increased dissatisfaction with care, and significant changes in physiological parameters are reported as occurring due to procedural pain. Procedural pain is important in all age groups, but it is a condition that requires particular attention in pediatric patients.
The response to procedural pain in children involves a complex interplay of individual and contextual factors, including age, developmental level, medical history, and parental involvement. Children may exhibit various responses to pain: physical (e.g., aggressive behavior, crying), physiological (e.g., increased heart rate and respiration), and psychological (e.g., anxiety, fear). Effective management of procedural pain has become increasingly important, encompassing both pharmacological and non-pharmacological interventions. Non-pharmacological methods, such as distraction techniques (e.g., video viewing, music therapy), have gained traction in pediatric care, particularly during invasive procedures. Despite the promising findings in the literature regarding pain management, there remains a gap in comprehensive studies addressing the role of distractions and the potential negative emotional experiences associated with procedural interventions, such as anxiety during peripheral venous catheter placement. Additionally, recent research explores the use of virtual reality and video viewing methods to assess procedural pain and anxiety, utilizing physiological monitoring without incurring costs.
The aim of this randomized controlled experimental study is to investigate the effects of virtual reality glasses and screen-based video viewing methods on physiological parameters (pulse, oxygen saturation, and respiration), procedural pain, fear, and emotional responses in children aged 7-12 years during peripheral venous catheter placement. This research will guide nursing approaches in managing pain, fear, and emotional responses that may occur in children during invasive procedures by examining the effect of video viewing with two different methods (screen-based and virtual reality glasses) from current approaches in procedural pain management. Managing physiological and psychological responses to procedural pain in children will affect satisfaction with nursing care in the short term, while, in the long term, it will increase the applicability of child-centered and atraumatic care today.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Headset Group (VRHG) | Experimental | Other: Virtual Reality Headset Group (VRHG)The use of virtual reality (VR) headsets to present audiovisual content to children. |
| On-screen Video Viewing Group (OVVG) | Experimental | Other: On-screen Video Viewing Group (OVVG)The use of on-screen audiovisual content for children |
| Control Group (CG) | Other | Other: Control Group (CG)No interventions beyond standard service routines for peripheral venous access were performed. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child should be monitored at the hospital for a minimum of 30 minutes and a maximum of 6 hours during the planned training.
- The child should be able to understand and speak Turkish fluently.
- Child must be aged 7-12 years old.
- Prior to the assessment process, the child's Wong-Baker Facial Expression Assessment Scale score must be 0.
- There should be no condition in the hand and arm area that would prevent the establishment of planned peripheral venous access.
Key exclusion criteria (13 listed)
- The child or parent does not wish to participate in the study
- The child has a history of sedative or narcotic substance use within the last 24 hours
- The child has received analgesia within the last 6 hours
- The child has a visual health problem
- The child has a hearing health problem
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 Headset Group (VRHG)The child and their family in this group were given information about virtual reality goggles, infection control materials (a disposable surgical cap and a virtual reality goggle pad), a saturation device, and an underwater video (https://www.youtube.com/watch?v=XEkUy7a8vfI). The headset was disinfected before the procedure. The virtual reality goggles were adjusted to fit the child's head, and the lens was adjusted according to the child's feedback to ensure video clarity. The video began 2 minutes before the peripheral venous catheter placement procedure. The peripheral venous catheter placement was performed by the ward head nurse. After the peripheral venous catheter was placed, the child watched the video for another two minutes. The child's total video viewing time was 4 minutes. The headset was disinfected after the procedure. | Other | Virtual Reality Headset Group (VRHG) |
| On-screen Video Viewing Group (OVVG)The materials to be used for the child and their family in this group, including a phone screen, screen holder, headphones, infection control materials (ear cap), a saturation device, and a submarine video (https://www.youtube.com/watch?v=XEkUy7a8vfI), were introduced.Before the procedure, the phone screen, screen holder, and headphones were disinfected. After the phone screen was placed in the holder, it was placed on a table 50 cm away from the child's eye level in the area where the procedure would be performed. The child's ability to see the screen properly was assessed. Based on the child's feedback, the table was set to 45-55 cm. The headphones to be used in the procedure were placed appropriately on the child's head and ears. The headphones' volume was adjusted to the appropriate level for the child based on the child's feedback. The video began 2 minutes before the peripheral venous catheter placement procedure. The peripheral venous catheter placement procedure was performed | Other | On-screen Video Viewing Group (OVVG) |
| Control Group (CG)In the pediatric emergency department, no interventions beyond standard service routines for peripheral venous access were performed; however, for this study, CG components and a saturation device were introduced. Peripheral venous placement was performed by the registered service supervisor. | Other | Control Group (CG) |
Primary outcome
Physiological Parameters Assessment Form
Time frame: Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)
This form was designed to measure physiological parameters affected by pain (pulse rate, respiratory rate, and oxygen saturation). Blood pressure and fever parameters, which are not affected by short-term procedural pain as mentioned in the literature, were not included in this form. The aim of the study is to ensure that the child's physiological parameters remain within normal limits in the intervention groups.
Wong-Baker Faces Pain Raiting Scale (WB-FPRS)
Time frame: Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)
Developed by Wong and Connie Morain Baker in 1981 and updated in 1983, the scale is used to measure pain in children aged 3-18 years. The scale includes five different facial expressions, each corresponding to a number between 0 and 10. Higher numbers indicate higher pain levels. In this study, it was expected that the intervention groups would have lower pain scores.
Children's Fear Scale (CFS)
Time frame: Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)
CFS, developed by McMurtry et al. (2011), is a visual scale containing five different facial expressions (hairless, gender-informed) and a rapid scale ranging from 0 (neutral facial expression) to 4 (extremely fearful-anxious facial expression) for each facial expression. A higher score on the scale indicates a greater capacity for fear in adolescents. The study expects the intervention groups to have lower CFS scores.
Children's Emotional Manifestation Scale (CEMS)
Time frame: Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)
Li and Lopez (2005) developed a comprehensive five-section assessment scale, comprising facial expression, voice acting, activity, interaction, and cooperation, scored from 1 to 5. In this context, scores on the Critical Disorder of Emotional State (CDVD) range from 5 (lowest) to 25 (highest), with lower scores indicating a heightened negative emotional state. Results indicated that intervention groups showed significantly lower mean scale scores.
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 2 Apr 2026.
- Individual participant dataSharing planned: No. If necessary, researchers will be contacted, and the sharing status will be reviewed again based on the study's type and purpose.
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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.
Sevil Özkan, Assist Prof study director
Selcuk University Faculty of Nursing
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 Headset Group (VRHG) and On-screen Video Viewing Group (OVVG) in people with Patient and Child, run by Ali Yıldız 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 13 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 2 Apr 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?
Physiological Parameters Assessment Form (time frame: Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)). The study lists 4 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 2 Apr 2026.