Intravenous CatheterizationNCT05892107
Effect of Toy and Mask Use on Pain and Anxiety in Children
A study testing Toy Group and Mask group with cartoon characters in people with Intravenous Catheterization, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Invasive painful interventions such as diagnostic and therapeutic procedures, blood sampling, injection and vaccine administration are among the greatest fears of children and lead to undesirable experiences both in children and in parents and healthcare personnel due to children's reactions to pain (İnal \&Canbulat… Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Intravenous Catheterization
- What is being tested?
- Toy Group and Mask group with cartoon characters
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 15 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The parent's verbal and written acceptance of the informed consent form,
- The child has not been given any medication with analgesic effect in the last 6 hours,
- Opening the vascular access on the first attempt,
- Body temperature between 36.5-37.2⁰C,
- The child does not have a chronic disease that requires frequent invasive procedures,
- The child does not have a disease that can cause chronic pain,
- The child does not have a mental or neurological disability that would affect participation in the research
Who cannot join
- Failure of the parent to verbally and in writing accept the informed consent form for participation in the study,
- The child has taken a drug with analgesic, antipyretic, anti-inflammatory effect in the last 6 hours,
- Failure to open the vascular access on the first attempt,
- The child's body temperature is above 37.2⁰C,
- Have a chronic disease that requires frequent invasive procedures,
- The child has a disease that can cause chronic pain,
- The child has an intellectual or neurological disability.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Songül Okşar
Istanbul, Şişli, 34360
Songül Okşar, +90 212 414 3000 ext. 67282, songul.gezer@iuc.edu.tr
Birsen Mutlu, +90 212 404 0300 ext. 27406, bdonmez@iuc.edu.tr
About this study
Official title: The Effect of Using Toy and Cartoon Character Masks on Pain and Anxiety During Peripheral Intravenous Catheterization in Children
Invasive painful interventions such as diagnostic and therapeutic procedures, blood sampling, injection and vaccine administration are among the greatest fears of children and lead to undesirable experiences both in children and in parents and healthcare personnel due to children's reactions to pain (İnal \&Canbulat 2015;Tuna 2014; Wolyniez et al. 2013). It is important for healthcare personnel to spend additional time to manage the child's pain, anxiety and fear of medical procedures (Longobardi et al. 2019, Chen et al. 2020). The American Academy of Pediatrics and the American Pain Society recommend alleviating or minimizing stress and pain, including practices such as venipuncture (Özel \&Çetin 2020). Pharmacologic and nonpharmacologic techniques are applied to reduce the emotional and physical effects of painful intervention (Özel \&Çetin 2020).
This study was planned to investigate the effect of the nurse's use of a mask with a cartoon character and the child's playing with a sound and light toy on the child's pain and parental anxiety during peripheral intravenous catheterization.
Read the detailed description
Invasive painful interventions such as diagnostic and therapeutic procedures, blood sampling, injection and vaccine administration are among the greatest fears of children and lead to undesirable experiences both in children and in parents and healthcare personnel due to children's reactions to pain. Especially anxiety, fear and behavioral problems caused by interventional procedures exacerbate children's pain and may prevent the procedure (İnal \&Canbulat 2015;Tuna 2014; Wolyniez et al. 2013). It is important for healthcare personnel to spend additional time to manage the child's pain, anxiety and fear of medical procedures (Longobardi et al. 2019, Chen et al. 2020). The American Academy of Pediatrics and the American Pain Society recommend alleviating or minimizing stress and pain, including practices such as venipuncture (Özel \&Çetin 2020).
Pain treatment requires a multidisciplinary team approach. One of the indispensable members of this team is the nurse. One of the care philosophies of pediatric nursing is atraumatic care. In this context, reducing the pain of the child and the physical and emotional effects that pain may cause is one of the most important tasks of the nurse (Çöçelli et al. 2008; Semerci et al. 2020).
Pharmacologic and nonpharmacologic techniques are applied to reduce the emotional and physical effects of painful intervention (Özel \&Çetin 2020). Nonpharmacologic pain relief methods are preferred because they are both cost-effective and non-invasive and have no risk of side effects (Mohebbi \& Azimzadeh 2014). In recent years, research on the use of nonpharmacologic methods by nurses to relieve pain in painful procedures has increased (İnal \&Canbulat 2015). Studies have shown that nonpharmacologic methods can be effective alone, especially in pain related to invasive interventions, and when used in combination with pharmacologic methods, they increase the effectiveness of drugs (Uğurlu 2017).
Researchers have reported that the use of distraction technique during painful procedures resulted in less pain reported by children (Dumoulin et al. 2019). In the preschool age group, various distraction activities such as playing with distraction cards, squeezing soft balls, blowing balloons, blowing soap bubbles, playing with dough or Buzzy, guided imagery, and listening to music are utilized ( Chen et al. 2020; Krauss et al. 2016).
In a study in which distraction cards were used during blood sampling, it was found that the use of these cards was effective in relieving pain in children (İnal \&Kelleci 2012). In another study conducted to determine the effect of watching cartoons on pain scores and crying duration in children aged 3-6 years during intravenous access, it was found that watching cartoons was a non-pharmacologic pain relief method that decreases pain perception by distracting the child (Akgül et al. 2018).
In a study conducted with children aged 4-6 years, it was found that squeezing a soft ball as a distraction technique could decrease the pain of children during intravenous catheter placement (Sadeghi et al. 2013). In a study conducted to determine the effects of watching animation during blood sampling on pain response in preschool children, statistically significant differences were found in pain, blood cortisol and blood glucose levels in the intervention group (Yoo et al. 2011).
Various masks are used to protect against viruses and bacteria or to avoid infecting people around them. Experts argue that wearing a mask is one of the most effective methods to protect against the coronavirus outbreak during the pandemic process we are in (Ünal \&Gökçen 2020). Wearing a mask that will attract the attention and attention of children by healthcare professionals working in pediatric clinics and intervening in children will not frighten the child and may also reduce the perception of procedural pain. It is also thought to be a non-invasive and cost-effective non-pharmacologic intervention to reduce pain.
This study was planned to investigate the effect of the nurse's use of a mask with a cartoon character and the child's playing with a sound and light toy on the child's pain and parental anxiety during peripheral intravenous catheterization.
- Conditions
- Intravenous Catheterization
- Being tested
- Toy Group, Mask group with cartoon characters, Control group
- Keywords
- Children, Pain, Cartoon Character Mask, Catheterization, Intravenous Catheterization, Anxiety, Toy
- 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.
Toy GroupProcedure or surgery
After meeting the children in the toy group, the toy will be given to the children to play 1 minute before the procedure. Before nonpharmacological interventions in all groups and 2 minutes before the procedure in the control group, the child's pre-procedural pain will be evaluated by explaining the Wong-Baker Faces Pain Rating Scale to the child.
Mask group with cartoon charactersProcedure or surgery
The nurse who will open the vascular access with the children in the cartoon character mask group will meet the child 1 minute before the procedure with a cartoon character mask on his/her face.In all groups, the mother will be present with the child during the blood collection procedure. Before nonpharmacological interventions in all groups and 2 minutes before the procedure in the control group, the child's pre-procedural pain will be evaluated by explaining the Wong-Baker Faces Pain Rating Scale to the child.
Control groupProcedure or surgery
In the control group, the nurse who will open the vascular access will meet the child 1 minute before the procedure with a white mask on her/his face. Children in the control group will be subjected to routine procedures before blood collection.In all groups, the mother will be present with the child during the blood collection procedure. Before nonpharmacological interventions in all groups and 2 minutes before the procedure in the control group, the child's pre-procedural pain will be evaluated by explaining the Wong-Baker Faces Pain Rating Scale to the child.
| Study group | Role | What they receive |
|---|---|---|
| Toy Group | Experimental | 1. Before the toy is given to the child, the child's pre-procedure pain will be assessed with the Wong-Baker Faces Pain Rating Scale.
2. 2 minutes before the procedure, the parent will be asked to assess the child's pain with VAS (Visual Analog Scale) and their own anxiety level with State Anxiety Inventory.
3. Body temperature will be measured before the procedure.
4. Children will be given a toy 1 minute before the procedure.
5. The child's pain during the procedure will be assessed by the child using the Wong-Baker Faces Pain Rating Scale.
6. 2 minutes after the procedure, the mother will re-evaluate the child's pain during the procedure using the Visual Analog Scale (VAS) and anxiety during the procedure using the State Anxiety Scale. Receives: Procedure: Toy Group |
| Mask group with cartoon characters | Experimental | 1. The child's pain will be assessed with the Wong-Baker Faces Pain Rating Scale before the procedure.
2. 2 minutes before the procedure, the parent will be asked to assess the child's pain with VAS (Visual Analog Scale) and their own anxiety level with State Anxiety Inventory.
3. Body temperature will be measured before the procedure.
4. 1 minute before the procedure, the nurse will greet the child with a mask.
5. During the procedure, the child's pain will be assessed by the child using the Wong-Baker Faces Pain Rating Scale.
6. 2 minutes after the procedure, the mother will reassess the child's pain during the procedure using the Visual Analog Scale (VAS) and anxiety during the procedure using the State Anxiety Scale. Receives: Procedure: Mask group with cartoon characters |
| Control Group | Active comparator | 1. Before the procedure, the child's pain will be assessed with the Wong-Baker Faces Pain Rating Scale.
2. 2 minutes before the procedure, the parent will be asked to assess the child's pain with VAS (Visual Analog Scale) and their own anxiety level with State Anxiety Inventory.
3. Body temperature will be measured before the procedure.
4. 1 minute before the procedure, the nurse will greet the child with a white mask on his/her face.
5. Children in the control group will be subjected to routine procedures (presence of the mother) during blood collection.
6. During the procedure, the child's pain will be assessed by the child using the Wong-Baker Faces Pain Rating Scale.
7. 2 minutes after the procedure, the mother will reassess the child's pain during the procedure using the Visual Analog Scale (VAS) and anxiety during the procedure using the State Anxiety Scale. Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in children's pain level
The pain level of the children will be evaluated with the Wong Baker Pain Scale.
Measured: 2 minutes before the procedure and 2 minutes after the procedure
Secondary outcomes (1)
Parental anxiety score
The mother's level of anxiety will be scored using the State Anxiety scale.
Measured: 2 minutes before the procedure and 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 posted7 Jun 2023
- Study start15 Feb 2022
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Intravenous CatheterizationStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled experimental design
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül OKŞAR, Istanbul University - Cerrahpasa
- Investigators
- Birsen MUTLU, Ph.d, Principal investigator, Istanbul University - CerrahpasaSongül OKŞAR, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892107
- Sponsor's protocol ID
- SNGL03032022
- Status last verified
- Jun 2023
- First submitted
- 18 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akgul EA, Karahan Y, Basoglu F, Ogul A, Oztornaci BO, Yetim P, Sari HY. Effects of watching cartoons on pain scores in children undergoing venepuncture. Nurs Child Young People. 2018 Dec 13. doi: 10.7748/ncyp.2018.e913. Online ahead of print.
PubMed 31468905Chen YJ, Cheng SF, Lee PC, Lai CH, Hou IC, Chen CW. Distraction using virtual reality for children during intravenous injections in an emergency department: A randomised trial. J Clin Nurs. 2020 Feb;29(3-4):503-510. doi: 10.1111/jocn.15088. Epub 2019 Dec 4.
PubMed 31715039Çöçelli, L. P., Bacaksız, B. D., & Ovayolu, N. (2008). The role of the nurse in pain treatment. Gaziantep Medical Journal, 14(2), 53-58.
Dumoulin S, Bouchard S, Ellis J, Lavoie KL, Vezina MP, Charbonneau P, Tardif J, Hajjar A. A Randomized Controlled Trial on the Use of Virtual Reality for Needle-Related Procedures in Children and Adolescents in the Emergency Department. Games Health J. 2019 Aug;8(4):285-293. doi: 10.1089/g4h.2018.0111. Epub 2019 May 24.
PubMed 31135178Inal, S., Canbulat, N. (2015). The use of distraction methods in procedural pain management in children. Journal of Health Sciences and Professions, 2(3), 372-378.
Inal S, Kelleci M. Distracting children during blood draw: looking through distraction cards is effective in pain relief of children during blood draw. Int J Nurs Pract. 2012 Apr;18(2):210-9. doi: 10.1111/j.1440-172X.2012.02016.x.
PubMed 22435986Krauss BS, Calligaris L, Green SM, Barbi E. Current concepts in management of pain in children in the emergency department. Lancet. 2016 Jan 2;387(10013):83-92. doi: 10.1016/S0140-6736(14)61686-X. Epub 2015 Jun 18.
PubMed 26095580Longobardi C, Prino LE, Fabris MA, Settanni M. Soap bubbles as a distraction technique in the management of pain, anxiety, and fear in children at the paediatric emergency room: A pilot study. Child Care Health Dev. 2019 Mar;45(2):300-305. doi: 10.1111/cch.12633. Epub 2018 Dec 12.
PubMed 30466144Mohebbi, P., & Azimzadeh, R. (2014). Barrier of implementing non-pharmacological pain management in children and presented intereventions by nurses. Journal of Holistic Nursing and Midwifery, 24(2), 40-48.
Ozel A, Cetin H. [Effects of vibrating tourniquet application on the pain felt for blood drawing in pediatric patients]. Agri. 2020 Jan;32(1):25-30. doi: 10.14744/agri.2019.04900. Turkish.
PubMed 32030695Semerci R, Kocaaslan EN, Akgun Kostak M, Akin N. [Reduction of pain during intravenous cannulation in children: Buzzy application]. Agri. 2020 Nov;32(4):177-185. doi: 10.14744/agri.2020.02223. Turkish.
PubMed 33398861Sadeghi T, Mohammadi N, Shamshiri M, Bagherzadeh R, Hossinkhani N. Effect of distraction on children's pain during intravenous catheter insertion. J Spec Pediatr Nurs. 2013 Apr;18(2):109-14. doi: 10.1111/jspn.12018. Epub 2013 Mar 5.
PubMed 23560582Tuna, P. T. (2014). The effect of practices to prepare for the procedure before peripheral cannula application on pain and anxiety in children (Master's thesis, ESOGÜ, Graduate School of Health Sciences).
Wolyniez I, Rimon A, Scolnik D, Gruber A, Tavor O, Haviv E, Glatstein M. The effect of a medical clown on pain during intravenous access in the pediatric emergency department: a randomized prospective pilot study. Clin Pediatr (Phila). 2013 Dec;52(12):1168-72. doi: 10.1177/0009922813502257. Epub 2013 Sep 11.
PubMed 24028842Yoo H, Kim S, Hur HK, Kim HS. The effects of an animation distraction intervention on pain response of preschool children during venipuncture. Appl Nurs Res. 2011 May;24(2):94-100. doi: 10.1016/j.apnr.2009.03.005. Epub 2009 Jul 15.
PubMed 20974061
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Toy and Cartoon Character Masks on Pain and Anxiety During Peripheral Intravenous Catheterization in Children
- ClinicalTrials.gov ID
- NCT05892107
- Acronym / sponsor ID
- SNGL03032022
- Conditions
- Intravenous Catheterization
- Keywords
- Children, Pain, Cartoon Character Mask, Catheterization, Intravenous Catheterization, Anxiety, Toy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 7 Jun 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.
Invasive painful interventions such as diagnostic and therapeutic procedures, blood sampling, injection and vaccine administration are among the greatest fears of children and lead to undesirable experiences both in children and in parents and healthcare personnel due to children's reactions to pain (İnal \&Canbulat 2015;Tuna 2014; Wolyniez et al. 2013). It is important for healthcare personnel to spend additional time to manage the child's pain, anxiety and fear of medical procedures (Longobardi et al. 2019, Chen et al. 2020). The American Academy of Pediatrics and the American Pain Society recommend alleviating or minimizing stress and pain, including practices such as venipuncture (Özel \&Çetin 2020). Pharmacologic and nonpharmacologic techniques are applied to reduce the emotional and physical effects of painful intervention (Özel \&Çetin 2020).
This study was planned to investigate the effect of the nurse's use of a mask with a cartoon character and the child's playing with a sound and light toy on the child's pain and parental anxiety during peripheral intravenous catheterization.
Detailed description
Invasive painful interventions such as diagnostic and therapeutic procedures, blood sampling, injection and vaccine administration are among the greatest fears of children and lead to undesirable experiences both in children and in parents and healthcare personnel due to children's reactions to pain. Especially anxiety, fear and behavioral problems caused by interventional procedures exacerbate children's pain and may prevent the procedure (İnal \&Canbulat 2015;Tuna 2014; Wolyniez et al. 2013). It is important for healthcare personnel to spend additional time to manage the child's pain, anxiety and fear of medical procedures (Longobardi et al. 2019, Chen et al. 2020). The American Academy of Pediatrics and the American Pain Society recommend alleviating or minimizing stress and pain, including practices such as venipuncture (Özel \&Çetin 2020).
Pain treatment requires a multidisciplinary team approach. One of the indispensable members of this team is the nurse. One of the care philosophies of pediatric nursing is atraumatic care. In this context, reducing the pain of the child and the physical and emotional effects that pain may cause is one of the most important tasks of the nurse (Çöçelli et al. 2008; Semerci et al. 2020).
Pharmacologic and nonpharmacologic techniques are applied to reduce the emotional and physical effects of painful intervention (Özel \&Çetin 2020). Nonpharmacologic pain relief methods are preferred because they are both cost-effective and non-invasive and have no risk of side effects (Mohebbi \& Azimzadeh 2014). In recent years, research on the use of nonpharmacologic methods by nurses to relieve pain in painful procedures has increased (İnal \&Canbulat 2015). Studies have shown that nonpharmacologic methods can be effective alone, especially in pain related to invasive interventions, and when used in combination with pharmacologic methods, they increase the effectiveness of drugs (Uğurlu 2017).
Researchers have reported that the use of distraction technique during painful procedures resulted in less pain reported by children (Dumoulin et al. 2019). In the preschool age group, various distraction activities such as playing with distraction cards, squeezing soft balls, blowing balloons, blowing soap bubbles, playing with dough or Buzzy, guided imagery, and listening to music are utilized ( Chen et al. 2020; Krauss et al. 2016).
In a study in which distraction cards were used during blood sampling, it was found that the use of these cards was effective in relieving pain in children (İnal \&Kelleci 2012). In another study conducted to determine the effect of watching cartoons on pain scores and crying duration in children aged 3-6 years during intravenous access, it was found that watching cartoons was a non-pharmacologic pain relief method that decreases pain perception by distracting the child (Akgül et al. 2018).
In a study conducted with children aged 4-6 years, it was found that squeezing a soft ball as a distraction technique could decrease the pain of children during intravenous catheter placement (Sadeghi et al. 2013). In a study conducted to determine the effects of watching animation during blood sampling on pain response in preschool children, statistically significant differences were found in pain, blood cortisol and blood glucose levels in the intervention group (Yoo et al. 2011).
Various masks are used to protect against viruses and bacteria or to avoid infecting people around them. Experts argue that wearing a mask is one of the most effective methods to protect against the coronavirus outbreak during the pandemic process we are in (Ünal \&Gökçen 2020). Wearing a mask that will attract the attention and attention of children by healthcare professionals working in pediatric clinics and intervening in children will not frighten the child and may also reduce the perception of procedural pain. It is also thought to be a non-invasive and cost-effective non-pharmacologic intervention to reduce pain.
This study was planned to investigate the effect of the nurse's use of a mask with a cartoon character and the child's playing with a sound and light toy on the child's pain and parental anxiety during peripheral intravenous catheterization.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled experimental design
| Arm | Type | Receives |
|---|---|---|
| Toy Group | Experimental | Procedure: Toy Group1. Before the toy is given to the child, the child's pre-procedure pain will be assessed with the Wong-Baker Faces Pain Rating Scale. 2. 2 minutes before the procedure, the parent will be asked to assess the child's pain with VAS (Visual Analog Scale) and their own anxiety level with State Anxiety Inventory. 3. Body temperature will be measured before the procedure. 4. Children will be given a toy 1 minute before the procedure. 5. The child's pain during the procedure will be assessed by the child using the Wong-Baker Faces Pain Rating Scale. 6. 2 minutes after the procedure, the mother will re-evaluate the child's pain during the procedure using the Visual Analog Scale (VAS) and anxiety during the procedure using the State Anxiety Scale. |
| Mask group with cartoon characters | Experimental | Procedure: Mask group with cartoon characters1. The child's pain will be assessed with the Wong-Baker Faces Pain Rating Scale before the procedure. 2. 2 minutes before the procedure, the parent will be asked to assess the child's pain with VAS (Visual Analog Scale) and their own anxiety level with State Anxiety Inventory. 3. Body temperature will be measured before the procedure. 4. 1 minute before the procedure, the nurse will greet the child with a mask. 5. During the procedure, the child's pain will be assessed by the child using the Wong-Baker Faces Pain Rating Scale. 6. 2 minutes after the procedure, the mother will reassess the child's pain during the procedure using the Visual Analog Scale (VAS) and anxiety during the procedure using the State Anxiety Scale. |
| Control Group | Active comparator | Procedure: Control group1. Before the procedure, the child's pain will be assessed with the Wong-Baker Faces Pain Rating Scale. 2. 2 minutes before the procedure, the parent will be asked to assess the child's pain with VAS (Visual Analog Scale) and their own anxiety level with State Anxiety Inventory. 3. Body temperature will be measured before the procedure. 4. 1 minute before the procedure, the nurse will greet the child with a white mask on his/her face. 5. Children in the control group will be subjected to routine procedures (presence of the mother) during blood collection. 6. During the procedure, the child's pain will be assessed by the child using the Wong-Baker Faces Pain Rating Scale. 7. 2 minutes after the procedure, the mother will reassess the child's pain during the procedure using the Visual Analog Scale (VAS) and anxiety during the procedure using the State Anxiety Scale. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The parent's verbal and written acceptance of the informed consent form,
- The child has not been given any medication with analgesic effect in the last 6 hours,
- Opening the vascular access on the first attempt,
- Body temperature between 36.5-37.2⁰C,
- The child does not have a chronic disease that requires frequent invasive procedures,
Key exclusion criteria (7 listed)
- Failure of the parent to verbally and in writing accept the informed consent form for participation in the study,
- The child has taken a drug with analgesic, antipyretic, anti-inflammatory effect in the last 6 hours,
- Failure to open the vascular access on the first attempt,
- The child's body temperature is above 37.2⁰C,
- Have a chronic disease that requires frequent invasive procedures,
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 |
|---|---|---|
| Toy GroupAfter meeting the children in the toy group, the toy will be given to the children to play 1 minute before the procedure. Before nonpharmacological interventions in all groups and 2 minutes before the procedure in the control group, the child's pre-procedural pain will be evaluated by explaining the Wong-Baker Faces Pain Rating Scale to the child. | Procedure or surgery | Toy Group |
| Mask group with cartoon charactersThe nurse who will open the vascular access with the children in the cartoon character mask group will meet the child 1 minute before the procedure with a cartoon character mask on his/her face.In all groups, the mother will be present with the child during the blood collection procedure. Before nonpharmacological interventions in all groups and 2 minutes before the procedure in the control group, the child's pre-procedural pain will be evaluated by explaining the Wong-Baker Faces Pain Rating Scale to the child. | Procedure or surgery | Mask group with cartoon characters |
| Control groupIn the control group, the nurse who will open the vascular access will meet the child 1 minute before the procedure with a white mask on her/his face. Children in the control group will be subjected to routine procedures before blood collection.In all groups, the mother will be present with the child during the blood collection procedure. Before nonpharmacological interventions in all groups and 2 minutes before the procedure in the control group, the child's pre-procedural pain will be evaluated by explaining the Wong-Baker Faces Pain Rating Scale to the child. | Procedure or surgery | Control Group |
Primary outcome
Change in children's pain level
Time frame: 2 minutes before the procedure and 2 minutes after the procedure
The pain level of the children will be evaluated with the Wong Baker Pain Scale.
1 secondary outcome
Parental anxiety score
Time frame: 2 minutes before the procedure and 2 minutes after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Background: PubMed 31468905Akgul EA, Karahan Y, Basoglu F, Ogul A, Oztornaci BO, Yetim P, Sari HY. Effects of watching cartoons on pain scores in children undergoing venepuncture. Nurs Child Young People. 2018 Dec 13. doi: 10.7748/ncyp.2018.e913. Online ahead of print.
- Background: PubMed 31715039Chen YJ, Cheng SF, Lee PC, Lai CH, Hou IC, Chen CW. Distraction using virtual reality for children during intravenous injections in an emergency department: A randomised trial. J Clin Nurs. 2020 Feb;29(3-4):503-510. doi: 10.1111/jocn.15088. Epub 2019 Dec 4.
- BackgroundÇöçelli, L. P., Bacaksız, B. D., & Ovayolu, N. (2008). The role of the nurse in pain treatment. Gaziantep Medical Journal, 14(2), 53-58.
- Background: PubMed 31135178Dumoulin S, Bouchard S, Ellis J, Lavoie KL, Vezina MP, Charbonneau P, Tardif J, Hajjar A. A Randomized Controlled Trial on the Use of Virtual Reality for Needle-Related Procedures in Children and Adolescents in the Emergency Department. Games Health J. 2019 Aug;8(4):285-293. doi: 10.1089/g4h.2018.0111. Epub 2019 May 24.
- BackgroundInal, S., Canbulat, N. (2015). The use of distraction methods in procedural pain management in children. Journal of Health Sciences and Professions, 2(3), 372-378.
- Background: PubMed 22435986Inal S, Kelleci M. Distracting children during blood draw: looking through distraction cards is effective in pain relief of children during blood draw. Int J Nurs Pract. 2012 Apr;18(2):210-9. doi: 10.1111/j.1440-172X.2012.02016.x.
- Background: PubMed 26095580Krauss BS, Calligaris L, Green SM, Barbi E. Current concepts in management of pain in children in the emergency department. Lancet. 2016 Jan 2;387(10013):83-92. doi: 10.1016/S0140-6736(14)61686-X. Epub 2015 Jun 18.
- Background: PubMed 30466144Longobardi C, Prino LE, Fabris MA, Settanni M. Soap bubbles as a distraction technique in the management of pain, anxiety, and fear in children at the paediatric emergency room: A pilot study. Child Care Health Dev. 2019 Mar;45(2):300-305. doi: 10.1111/cch.12633. Epub 2018 Dec 12.
- BackgroundMohebbi, P., & Azimzadeh, R. (2014). Barrier of implementing non-pharmacological pain management in children and presented intereventions by nurses. Journal of Holistic Nursing and Midwifery, 24(2), 40-48.
- Background: PubMed 32030695Ozel A, Cetin H. [Effects of vibrating tourniquet application on the pain felt for blood drawing in pediatric patients]. Agri. 2020 Jan;32(1):25-30. doi: 10.14744/agri.2019.04900. Turkish.
- Background: PubMed 33398861Semerci R, Kocaaslan EN, Akgun Kostak M, Akin N. [Reduction of pain during intravenous cannulation in children: Buzzy application]. Agri. 2020 Nov;32(4):177-185. doi: 10.14744/agri.2020.02223. Turkish.
- Background: PubMed 23560582Sadeghi T, Mohammadi N, Shamshiri M, Bagherzadeh R, Hossinkhani N. Effect of distraction on children's pain during intravenous catheter insertion. J Spec Pediatr Nurs. 2013 Apr;18(2):109-14. doi: 10.1111/jspn.12018. Epub 2013 Mar 5.
Related trials for Intravenous Catheterization
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Not yet recruiting
Near-Infrared Light for Peripheral Venous Catheterization in Adults With Difficult Venous Access
Difficult Venous Access
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Enrolling by invitation
Use of Hand Extension Rubber During Intravenous Catheter Placement
Pain, Anxiety
Enrolling by invitation
Magic Show Featuring "Kuco" for Pain and Fear During Invasive Procedures
Procedure-Related Pain, Procedure-Related Fear
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.
Birsen MUTLU, Ph.d principal investigator
Istanbul University - Cerrahpasa
Songül OKŞAR principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toy Group and Mask group with cartoon characters in people with Intravenous Catheterization, run by Istanbul University - Cerrahpasa 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 7 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: status not confirmed, as of the sponsor's last update on 7 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Songül OKŞAR (+90 +90 212 414 3000 ext. 67282, songul.gezer@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in children's pain level (time frame: 2 minutes before the procedure and 2 minutes after the procedure). 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 NCT05892107, which also lists 17 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 7 Jun 2023.