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

June 6, 2023 updated by: Songül OKŞAR, Istanbul University - Cerrahpasa (IUC)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Birsen MUTLU, Ph.d
  • Phone Number: 27406 +90 +90 212 404 0300
  • Email: bdonmez@iuc.edu.tr

Study Locations

  • Turkey
    • Şişli
      • İstanbul, Şişli, Turkey, 34360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Experimental: 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.
Procedure: 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.
Active Comparator: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 minutes before the procedure and 2 minutes after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental anxiety score
Time Frame: 2 minutes before the procedure and 2 minutes after the procedure
The mother's level of anxiety will be scored using the State Anxiety scale.
2 minutes before the procedure and 2 minutes after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Birsen MUTLU, Ph.d, Istanbul University - Cerrahpasa (IUC)
  • Principal Investigator: Songül OKŞAR, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Estimated)

July 15, 2023

Study Completion (Estimated)

August 15, 2023

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SNGL03032022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intravenous Catheterization

Clinical Trials on Toy Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe