Effect of Toy and Mask Use on Pain and Anxiety in Children
NCT ID: NCT05892107
Last Updated: 2023-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
162 participants
INTERVENTIONAL
2022-02-15
2023-08-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical Procedure in Invasive Interventions
NCT05533827
Cartoons and Musical-moving Toys in Invasive Procedure Applications Reduce Pain and Fear Levels of Children
NCT05303454
The Effect of Two Distraction Methods on the Level of Pain, Fear and Anxiety in Children
NCT05588687
The Effect of The Musical Toy Used During Peripheral Vascular Access on Children's Pain, Fear And Parents' Satisfaction
NCT05689411
Effects of Interactive Toys and Robots on Anxiety and Fear in Children Receiving Nebulized Inhalation in the Pediatric Emergency Department
NCT07056816
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Toy Group
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.
Toy Group
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 characters
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.
Mask group with cartoon characters
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 Group
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.
Control group
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Toy Group
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 characters
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 group
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
4 Years
6 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istanbul University - Cerrahpasa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Songül OKŞAR
Clinical Nursing
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Birsen MUTLU, Ph.d
Role: PRINCIPAL_INVESTIGATOR
Istanbul University - Cerrahpasa
Songül OKŞAR
Role: PRINCIPAL_INVESTIGATOR
Istanbul University - Cerrahpasa
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Songül Okşar
Istanbul, Şişli, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Çöçelli, L. P., Bacaksız, B. D., & Ovayolu, N. (2008). The role of the nurse in pain treatment. Gaziantep Medical Journal, 14(2), 53-58.
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.
Chen 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.
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.
Inal, 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.
Krauss 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.
Longobardi 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.
Mohebbi, 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.
Semerci 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.
Sadeghi 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.
Tuna, 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.
Yoo 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.
Ugurlu, E. S. (2017). Nonpharmacologic pain relief methods in interventional procedures in children. Acıbadem University Journal of Health Sciences, 8(4), 198-201.
Ünal, Z., & Gökçen, Ö. (2020). Research on Surgical Masks and Mask Use in Children. Turkish Journal of Fashion Design and Management, 3(1), 11-24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SNGL03032022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.