Effect of Toy and Mask Use on Pain and Anxiety in Children

NCT05892107 | Unknown

• 1 other identifier: SNGL03032022
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Intravenous Catheterization

Keywords

Children; Pain; Cartoon Character Mask; Catheterization; Intravenous Catheterization; Anxiety; Toy

Outcome Measures

Primary Outcomes (1)

• Change in children's pain level

  The pain level of the children will be evaluated with the Wong Baker Pain Scale.

  2 minutes before the procedure and 2 minutes after the procedure

Secondary Outcomes (1)

• Parental anxiety score

  2 minutes before the procedure and 2 minutes after the procedure

Study Arms (3)

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.

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.

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.

Procedure: Control group

Interventions

Toy Group PROCEDURE

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.

Toy Group

Mask group with cartoon characters PROCEDURE

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.

Mask group with cartoon characters

Control group PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Songül Okşar

Istanbul, Şişli, 34360, Turkey (Türkiye)

RECRUITING

Related Publications (17)

• 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.

  PMID: 31468905 BACKGROUND

• 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.

  PMID: 31715039 BACKGROUND

• Çöçelli, L. P., Bacaksız, B. D., & Ovayolu, N. (2008). The role of the nurse in pain treatment. Gaziantep Medical Journal, 14(2), 53-58.

  BACKGROUND

• 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.

  PMID: 31135178 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22435986 BACKGROUND

• 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.

  PMID: 26095580 BACKGROUND

• 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.

  PMID: 30466144 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 32030695 BACKGROUND

• 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.

  PMID: 33398861 BACKGROUND

• 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.

  PMID: 23560582 BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 24028842 BACKGROUND

• 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.

  PMID: 20974061 BACKGROUND

• Ugurlu, E. S. (2017). Nonpharmacologic pain relief methods in interventional procedures in children. Acıbadem University Journal of Health Sciences, 8(4), 198-201.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Birsen MUTLU, Ph.d

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Songül OKŞAR

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Songül OKŞAR

CONTACT

+90 +90 212 414 3000; songul.gezer@iuc.edu.tr

Birsen MUTLU, Ph.d

CONTACT

+90 +90 212 404 0300; bdonmez@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nursing

Model Details: Randomized controlled experimental design

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 7, 2023
• Study Start: February 15, 2022
• Primary Completion: July 15, 2023
• Study Completion: August 15, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

TU (1)