Venipuncture Site ReactionNCT03645213
Two Different Distraction Methods on Pain and Fear During Venipuncture in Children
A study testing Virtual Reality Box and Tablet Computer in people with Venipuncture Site Reaction and Procedural Complication, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
Objective: Needle-related procedures (venipuncture, vaccine injections) are the most common source of pain and fear, and generally experienced in childhood for the first time. This study was designed to determine the effects of watching cartoon films on non-VR and VR virtual reality on pain and fear during… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Venipuncture Site Reaction, Procedural Complication, Nursing Caries
- What is being tested?
- Virtual Reality Box and Tablet Computer
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2017to 10 Aug 2018
- 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
- being between 7-12 years old,
- a physician order was placed for blood sample,
- no current acute pain,
- no cognitive or severe physical disability,
- no communication difficult,
Who cannot join
- the blood sample cannot be taken in the first attempt
- no consent of the parents for the child to take part in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparision of Two Different Distraction Methods on Pain and Fear During Venipuncture in School-Age Children: A Randomized Controlled Trial
Objective: Needle-related procedures (venipuncture, vaccine injections) are the most common source of pain and fear, and generally experienced in childhood for the first time. This study was designed to determine the effects of watching cartoon films on non-VR and VR virtual reality on pain and fear during venipuncture in school-age children and to compare these two methods.
Method: This randomized controlled trial study was conducted on 120 school-age children (7 -12 years of age) with pain and fear of venipuncture. The children were randomized according to their arrival in the biochemistry laboratory; the first, second, and third children were assigned VR distraction group with a headset (n=40), non-VR distraction group on a tablet computer screen (n=40) and no distraction group (n=40), respectively. The data collection was carried out using the children identification form, Wong-Baker FACES Pain Rating Scale evaluating the pain and Childrens' Fear Scale evaluating the fear. The outcomes reported by the children, parent, and observer.
Read the detailed description
Introduction: Needle procedures (eg, venipunctures, vaccine injections) are the most common and generally experienced in childhood for the first time. Children often describe needle procedures as the most painful and fearful intervention in the healthcare. The pain and fear of injections may affect the children psychologically and lead to situations such as refusal of interventions in children. Besides, these effects can disrupt the communication between nurses and children and cause distress to parents. Unmitigated pain during these procedures may increase fear which in turn can exacerbate future pain in an escalating relationship. However, there are no studies on the techniques applied to reduce pain and fear during venipuncture in school-age children, nor are there any comparing watching cartoon films and virtual reality. This study was carried out to determine the effects of watching cartoon films on non-VR and VR virtual reality on pain and fear during venipuncture in school-age children and to compare these two methods.
Study design A randomized controlled clinical trial was conducted.
The following hypotheses (H) were tested in this study:
H1. Watching cartoon films by non-VR distractor to children during venipuncture would be effective in controlling pain and fear.
H2. Watching cartoon films by VR distractor to children during venipuncture would be effective in controlling pain and fear.
Sample and Setting This study was conducted with 120 children, studying at the at the Biochemical Laboratory of Medipol University Hospital, Turkey between September 2017-April 2018. The sample included in the study were required to meet the eligibility criteria of being between 7-12 years old, a physician order was placed for blood sample, no current acute pain, no cognitive or severe physical disability, no communication difficult, blood sample was taken in the first attempt and consent of the parents for the child to take part in the research. The sample consisted of 120 out of the 147 children aged. Among the 27 children not included the sample group.
Childrens were divided into 3 groups. The children were randomized according to their arrival in the biochemistry laboratory; the first, second, and third children were assigned VR group (n=40), non-VR group (n=40) and control group (n=40), respectively. The outcome measures were the level of pain and fear by the children, the parent and blinded research observer, immediately after venipuncture procedures.
Data Collection Form Data collection was carried out using (a) the Children Identification Form prepared by the authors, (b) Wong-Baker FACES Pain Rating Scale and (c) Childrens' Fear Scale.
Procedure The procedure and reason were explained to the child before each step of the venipuncture process such as apply a tourniquet, insert and remove the needle. The parent stopped on the left side of the child's in all groups. The display was a head-mounted VR box in the VR group. The computer tablet was the 10 centimeters far from the child in the non-VR group.
- Being tested
- Virtual Reality Box, Tablet Computer
- Keywords
- School-age children, pain, fear, venipuncture, distraction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality BoxDevice
Virtual Reality box, a head-mounted display with stereo earphones transmits the cartoon image onto screens in front of the child's eyes. It was showed on Samsung Galaxy Note5 phone and Samsung Gear VR box /SM-R323N.
Tablet ComputerDevice
The tablet computer is a device that children watch on a 7-inch screen.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) | Experimental | Children were asked which cartoon they wanted to watch and it was prepared. The cartoons began to be shown a minute before venipuncture and lasted about 4 minutes. The procedure and reason were explained to the child before each step of the venipuncture process such as apply a tourniquet, insert and remove the needle. The parent stopped on the left side of the child's. The display was a head-mounted VR box in the VR group. Receives: Device: Virtual Reality Box |
| Non- Virtual Reality (VR) | Experimental | Children were asked which cartoon they wanted to watch and it was prepared. The cartoons began to be shown a minute before venipuncture and lasted about 4 minutes. The procedure and reason were explained to the child before each step of the venipuncture process such as apply a tourniquet, insert and remove the needle. The parent stopped on the left side of the child's. The display was a computer tablet in the non-VR group. The computer tablet was the 10 centimeters far from the child. Receives: Device: Tablet Computer |
| Control | No intervention | There was no additional intervention in the control group. Venipuncture procedures was the same other groups. The procedure and reason were explained to the child before each step of the venipuncture process such as apply a tourniquet, insert and remove the needle. The parent stopped on the left side of the child's. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measure
Used for the pain intensity during the procedure was the Wong-Baker FACES Pain Rating Scale (WB-FBRS) which is represented by six animated faces arranged side by side from the worst pain to the mildest one (0-5). The range of painfulness from the smiling "no pain" (0 points) to the crying face of "the worst pain" (5 points) translated into the Turkish language
Measured: Immediately after venipuncture
Secondary outcomes (1)
Fear Measure
The Childrens Fear Scale (CFS) is used to measure the anxiety or fear level of the children. The CFS is developed by McMurtry et al. 2011 based on the Faces Anxiety Scale to measure anxiety or fear in adults in the intensive care unit. The scale faces were drawn by a graphic artist according to the facial muscle changes involved in a fearful expression. The one-item scale consists of a row of five sex neutral faces ranging from a no fear (neutral) face on the far left to a face showing extreme fear on the far right.
Measured: Immediately after venipuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start18 Sep 2017
- Primary completion2 Apr 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venipuncture Site ReactionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled trial study was conducted on 120 school-age children (7 -12 years of age) with pain and fear of venipuncture. The children were randomized according to their arrival in the biochemistry laboratory; the first, second, and third children were assigned VR distraction group with a headset (n=40), non-VR distraction group on a tablet computer screen (n=40) and no distraction group (n=40), respectively. The data collection was carried out using the children identification form, Wong-Baker FACES Pain Rating Scale evaluating the pain and Childrens' Fear Scale evaluating the fear. The outcomes reported by the children, parent, and observer.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet İnangil, PhD, Istanbul Saglik Bilimleri University
- Investigators
- Merdiye Şendir, Proffessor, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645213
- Sponsor's protocol ID
- 10840098-604.01.01-E.40485
- Status last verified
- Aug 2018
- First submitted
- 10 Aug 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mutlu B, Balci S. Effects of balloon inflation and cough trick methods on easing pain in children during the drawing of venous blood samples: a randomized controlled trial. J Spec Pediatr Nurs. 2015 Jul;20(3):178-86. doi: 10.1111/jspn.12112. Epub 2015 Mar 28.
PubMed 25817062Karakaya A, Gozen D. The Effect of Distraction on Pain Level Felt by School-age Children During Venipuncture Procedure--Randomized Controlled Trial. Pain Manag Nurs. 2016 Feb;17(1):47-53. doi: 10.1016/j.pmn.2015.08.005. Epub 2015 Oct 12.
PubMed 26459008
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision of Two Different Distraction Methods on Pain and Fear During Venipuncture in School-Age Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03645213
- Acronym / sponsor ID
- 10840098-604.01.01-E.40485
- Keywords
- School-age children, pain, fear, venipuncture, distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 24 Aug 2018 (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.
Objective: Needle-related procedures (venipuncture, vaccine injections) are the most common source of pain and fear, and generally experienced in childhood for the first time. This study was designed to determine the effects of watching cartoon films on non-VR and VR virtual reality on pain and fear during venipuncture in school-age children and to compare these two methods.
Method: This randomized controlled trial study was conducted on 120 school-age children (7 -12 years of age) with pain and fear of venipuncture. The children were randomized according to their arrival in the biochemistry laboratory; the first, second, and third children were assigned VR distraction group with a headset (n=40), non-VR distraction group on a tablet computer screen (n=40) and no distraction group (n=40), respectively. The data collection was carried out using the children identification form, Wong-Baker FACES Pain Rating Scale evaluating the pain and Childrens' Fear Scale evaluating the fear. The outcomes reported by the children, parent, and observer.
Detailed description
Introduction: Needle procedures (eg, venipunctures, vaccine injections) are the most common and generally experienced in childhood for the first time. Children often describe needle procedures as the most painful and fearful intervention in the healthcare. The pain and fear of injections may affect the children psychologically and lead to situations such as refusal of interventions in children. Besides, these effects can disrupt the communication between nurses and children and cause distress to parents. Unmitigated pain during these procedures may increase fear which in turn can exacerbate future pain in an escalating relationship. However, there are no studies on the techniques applied to reduce pain and fear during venipuncture in school-age children, nor are there any comparing watching cartoon films and virtual reality. This study was carried out to determine the effects of watching cartoon films on non-VR and VR virtual reality on pain and fear during venipuncture in school-age children and to compare these two methods.
Study design A randomized controlled clinical trial was conducted.
The following hypotheses (H) were tested in this study:
H1. Watching cartoon films by non-VR distractor to children during venipuncture would be effective in controlling pain and fear.
H2. Watching cartoon films by VR distractor to children during venipuncture would be effective in controlling pain and fear.
Sample and Setting This study was conducted with 120 children, studying at the at the Biochemical Laboratory of Medipol University Hospital, Turkey between September 2017-April 2018. The sample included in the study were required to meet the eligibility criteria of being between 7-12 years old, a physician order was placed for blood sample, no current acute pain, no cognitive or severe physical disability, no communication difficult, blood sample was taken in the first attempt and consent of the parents for the child to take part in the research. The sample consisted of 120 out of the 147 children aged. Among the 27 children not included the sample group.
Childrens were divided into 3 groups. The children were randomized according to their arrival in the biochemistry laboratory; the first, second, and third children were assigned VR group (n=40), non-VR group (n=40) and control group (n=40), respectively. The outcome measures were the level of pain and fear by the children, the parent and blinded research observer, immediately after venipuncture procedures.
Data Collection Form Data collection was carried out using (a) the Children Identification Form prepared by the authors, (b) Wong-Baker FACES Pain Rating Scale and (c) Childrens' Fear Scale.
Procedure The procedure and reason were explained to the child before each step of the venipuncture process such as apply a tourniquet, insert and remove the needle. The parent stopped on the left side of the child's in all groups. The display was a head-mounted VR box in the VR group. The computer tablet was the 10 centimeters far from the child in the non-VR group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This randomized controlled trial study was conducted on 120 school-age children (7 -12 years of age) with pain and fear of venipuncture. The children were randomized according to their arrival in the biochemistry laboratory; the first, second, and third children were assigned VR distraction group with a headset (n=40), non-VR distraction group on a tablet computer screen (n=40) and no distraction group (n=40), respectively. The data collection was carried out using the children identification form, Wong-Baker FACES Pain Rating Scale evaluating the pain and Childrens' Fear Scale evaluating the fear. The outcomes reported by the children, parent, and observer.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) | Experimental | Device: Virtual Reality BoxChildren were asked which cartoon they wanted to watch and it was prepared. The cartoons began to be shown a minute before venipuncture and lasted about 4 minutes. The procedure and reason were explained to the child before each step of the venipuncture process such as apply a tourniquet, insert and remove the needle. The parent stopped on the left side of the child's. The display was a head-mounted VR box in the VR group. |
| Non- Virtual Reality (VR) | Experimental | Device: Tablet ComputerChildren were asked which cartoon they wanted to watch and it was prepared. The cartoons began to be shown a minute before venipuncture and lasted about 4 minutes. The procedure and reason were explained to the child before each step of the venipuncture process such as apply a tourniquet, insert and remove the needle. The parent stopped on the left side of the child's. The display was a computer tablet in the non-VR group. The computer tablet was the 10 centimeters far from the child. |
| Control | No intervention | –There was no additional intervention in the control group. Venipuncture procedures was the same other groups. The procedure and reason were explained to the child before each step of the venipuncture process such as apply a tourniquet, insert and remove the needle. The parent stopped on the left side of the child's. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- being between 7-12 years old,
- a physician order was placed for blood sample,
- no current acute pain,
- no cognitive or severe physical disability,
- no communication difficult,
Key exclusion criteria (2 listed)
- the blood sample cannot be taken in the first attempt
- no consent of the parents for the child to take part in the research
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 BoxVirtual Reality box, a head-mounted display with stereo earphones transmits the cartoon image onto screens in front of the child's eyes. It was showed on Samsung Galaxy Note5 phone and Samsung Gear VR box /SM-R323N. | Device | Virtual Reality (VR) |
| Tablet ComputerThe tablet computer is a device that children watch on a 7-inch screen. | Device | Non- Virtual Reality (VR) |
Primary outcome
Pain Intensity Measure
Time frame: Immediately after venipuncture
Used for the pain intensity during the procedure was the Wong-Baker FACES Pain Rating Scale (WB-FBRS) which is represented by six animated faces arranged side by side from the worst pain to the mildest one (0-5). The range of painfulness from the smiling "no pain" (0 points) to the crying face of "the worst pain" (5 points) translated into the Turkish language
1 secondary outcome
Fear Measure
Time frame: Immediately after venipuncture
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 24 Aug 2018.
- Results publication: PubMed 25817062Mutlu B, Balci S. Effects of balloon inflation and cough trick methods on easing pain in children during the drawing of venous blood samples: a randomized controlled trial. J Spec Pediatr Nurs. 2015 Jul;20(3):178-86. doi: 10.1111/jspn.12112. Epub 2015 Mar 28.
- Results publication: PubMed 26459008Karakaya A, Gozen D. The Effect of Distraction on Pain Level Felt by School-age Children During Venipuncture Procedure--Randomized Controlled Trial. Pain Manag Nurs. 2016 Feb;17(1):47-53. doi: 10.1016/j.pmn.2015.08.005. Epub 2015 Oct 12.
- Individual participant dataSharing planned: No
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.
Merdiye Şendir, Proffessor study director
Saglik Bilimleri Universitesi
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 Box and Tablet Computer in people with Venipuncture Site Reaction and Procedural Complication, run by Istanbul Saglik Bilimleri 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 2 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 24 Aug 2018. 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?
Pain Intensity Measure (time frame: Immediately after venipuncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03645213, which also lists 2 linked publications.
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 24 Aug 2018.