The Effects of Cartoon Watching and Bubble Blowing as Distraction Methods During Venipuncture on Pain, Anxiety, and Fear in Children Aged 6-8 Years
Condition: Pain; Anxiety; Fear; Child, Only
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Active and passive distraction methods are frequently used in the nursing management of
      procedural pain in children. There are no studies comparing the effects of cartoon watching
      (passive) and bubble blowing (active) as distraction methods on pain, anxiety, and fear
      associated with venipuncture in children.

      This study aimed to compare the effects of bubble blowing (active distraction) and cartoon
      watching (passive distraction) techniques on pain, anxiety, and fear during venipuncture in
      children aged 6-8 years.
    

Detailed description: 
      Research Hypotheses H1a= There is a difference in the mean WB-FACES score during the
      procedure between the bubble group (BG) and the cartoon group (CG).

      H1b= There is a difference in the mean WB-FACES score after the procedure between the BG and
      CG groups.

      H2a= There is a difference in the mean CSA score during the procedure between the BG and CG
      groups.

      H2b= There is a difference in the mean CSA score after the procedure between the BG and CG
      groups.

      H3a= There is a difference in the mean CFS score during the procedure between the BG and CG
      groups.

      H3b= There is a difference in the mean CFS score after the procedure between the BG and CG
      groups.

      Design and Settings: This parallel-group randomized trial was conducted at the invasive
      procedure room of the pediatrics department of a university hospital in the East
      Mediterranean Region of Turkey. For this experimental research, 56 children aged 6-8 years
      were assigned to two groups (Bubble Group=BG; n = 28 and Cartoon Group=CG; n = 28) using
      block randomization.

      Sample Size: The main trial sample was calculated based on the pilot study findings. The
      pilot study was conducted with 20 children (BG; n = 10 and CG; n = 10) who met the
      eligibility criteria. A priori power analysis was performed based on the effect size (d =
      0.885, large effect) of the difference in pain scores between the groups (during the
      procedure) determined in the pilot study. Using G*Power 3.1.9.7, the minimum sample size was
      calculated as 56 children, with 28 children per group, for a two-tailed hypothesis, an effect
      size of d = 0.885, an allocation ratio of n1/n2=1, type I error of 0.05, and a power of 90%.

      Randomization: Using block randomization, six different combinations of the codes A and B
      with a block size of 4 (ABAB(1), AABB(2), BABA(3) …) were generated. The combinations were
      numbered from 1 to 6. The numbers (1-6) were randomly sorted 14 times via randomizer.org and
      a random allocation sequence was generated. Coin flipping was used to determine which of the
      codes A and B would be BG and CG (R1). The random allocation sequence, which was placed in
      opaque envelopes by giving a sequence number, was hidden from the principal researchers (R2,
      R3) (allocation concealment). The opaque envelopes were stored in a locked cabinet by the
      researcher who performed the randomization (R1). The group including the eligible children
      was not shared with R2 and R3 until the intervention.

      Data Collection Tools Socio-Demographic Data Collection and Procedure Follow-up Form: It
      includes "age, gender, previous experience of hospitalization, experience of procedural pain
      in last week, analgesic administration at least six hours before the procedure, size of
      peripheral IV needle, area of IV blood sample, parental presence during procedure, and
      baseline data of pain, anxiety and fear scores of children before procedure".

      The Wong-Bakers FACES® Pain Rating Scale (WB-FACES): Developed by Wong and Baker in 1981 and
      revised in 1983, the instrument is used to assess physical pain in people who are
      communicative, responsive, and aged three years and older. The scale consists of faces
      ranging from "Face 0= no hurt" to "Face 10=hurts worst".

      The Children's State Anxiety Scale (CSA): Developed by Ersig et al. (2013), the Turkish
      validity-reliability study of this visual scale was conducted by Özalp-Gerçeker et al. (2018)
      and it is scored from 0 to 10. Higher values represent higher anxiety.

      The Children's Fear Scale (CFS): The instrument assessed the pain-associated fear in
      children. Developed by McMurty et al. (2011), the Turkish validity-reliability study of this
      visual scale was conducted by Özalp-Gerçeker et al. (2018) and it is scored from 0 to 4. It
      ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on
      the far right. Higher scores mean a worse outcome.

      Bubble Blowing Toy: In the bubble blowing group, a two-piece toy was used that had a chamber
      containing diluted liquid soap, a pattern of cartoon characters and a special apparatus to
      generate bubbles when blown.

      iPad mini: In the cartoon watching group, an iPad mini was used that had a (7.9 inch
      (diagonal) LED-backlit Multi-Touch display, 2048 x 1536 resolution with a density of 326
      pixels per inch (ppi) with internet access.

      Interventions: The invasive procedure room in the clinic was decorated with cartoon
      characters and ornaments on the walls. The intervention can be administered to only one child
      at a time in the room. In routine practice, the parental presence is supported during all
      invasive procedures performed on children. However, the nurses' uniforms have a print/pattern
      of cartoon characters in the routine practice. The room had the same characteristics for all
      children and their parents in terms of environmental conditions such as light, temperature,
      noise, and seat. Before the procedure, children's pain, anxiety, and fear were assessed after
      providing developmentally appropriate information. The parents were also informed about how
      to support their children. The same researchers performed the venipuncture (R2) and
      observational pain, anxiety, and fear assessments (R3) in all children. R2 and R3 are nurses
      with more than five years of experience in pediatrics and degrees in scientific fields.

      Bubble Blowing: First, the physical comfort of the children was ensured in the invasive
      procedure room. Then, the children were instructed to take a deep breath through the nose and
      generate bubbles by slowly blowing into the special apparatus. The children's questions about
      the procedure and the process were answered in a developmentally appropriate manner. The
      children were allowed to choose a bubble blowing toy according to the printed cartoon
      characters. The children were supported by their parents in holding the chamber of the toy.
      The children started to blow bubbles 3 minutes before the procedure. The procedure and the
      bubble blowing intervention were terminated simultaneously. The bubble blowing toy was given
      to the children as a gift after the intervention.

      Cartoon Watching: In the cartoon watching group, the cartoons that the children liked to
      watch were learned from the parents before the procedure. First, the physical comfort of the
      children was ensured in the invasive procedure room. The children were asked which cartoon
      they wanted to watch before the procedure. They started to watch the cartoon 3 minutes before
      the procedure. The children were supported by their parents in holding the tablet. The
      procedure and the cartoon watching intervention were terminated simultaneously.

      Statistical Methods: The study data were analyzed using the statistical package for Social
      Sciences. The level of statistical significance was set at 0.05. The normality of the data
      was determined by the kurtosis and skewness coefficients, revealing that the scale scores
      were normally distributed. The data were presented as mean, standard deviation, confidence
      interval, frequency, and percentages. The similarities of demographic and clinical
      characteristics between the groups were analyzed by the Chi-square test. The mean scale
      scores of the groups were compared using the Independent Samples t-test.

      Ethical Considerations: The study was granted approval by the clinical research ethics
      committee and written institutional permission by the hospital. Parents were informed about
      the procedure and that they could withdraw from the study at any time without explanation.
      Parents provided written consent and children verbal consent before the study.
    

Intervention name(s): Bubble Blowing; Cartoon Watching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Active Distraction Methods; Passive Distraction Methods
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Nursing; Pain Management; Distraction; Children