Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05161416 |
| Other study ID # |
MersinU*GUGUCU_001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2019 |
| Est. completion date |
March 2, 2020 |
Study information
| Verified date |
December 2021 |
| Source |
Mersin University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
