Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05412719 |
| Other study ID # |
2021/210 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
February 1, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Okan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
. In this determined, it was carried out to determine the effect of finger puppet play on
pain and physiological parameters during urine culture with urinary catheter in infants.
Research Hypotheses and Variables H0: There is no difference between the pain levels of
babies who were manipulated with finger puppets during urine culture sampling with urinary
catheter compared to babies in the control group.
H1: Babies whose finger puppet is played during urine culture sampling with urinary catheter
have low pain levels.
H2: Physiological parameters of babies who are played with finger puppets during urine
culture sample collection with urinary catheter are positively affected.
Description:
The research was designed as a randomizer controlled experimental study to determine the
effect of finger puppet manipulation on pain and physiological catheter parameters during
urinary culture with urinary catheterization in 2-12 month old infants. This Research was
conducted in pediatric emergency department of SBU Zeynep Kamil Women's and Children's
Diseases Training and Research Hospital between Feb.2021-Feb.2022. "Infant follow-up form"
and "FLAAC pain scale" were used to collect data. The data obtained from the research were
analyzed with appropriate statistical tests in the SPSS 22.0 package program.
Research Hypotheses and Variables H0: There is no difference between the pain levels of
babies who were manipulated with finger puppets during urine culture sampling with urinary
catheter compared to babies in the control group.
H1: Babies whose finger puppet is played during urine culture sampling with urinary catheter
have low pain levels.
H2: Physiological parameters of babies who are played with finger puppets during urine
culture sample collection with urinary catheter are positively affected.
Dependent Variables: Infants' physiological parameters (Pulse, Blood pressure, Respiration,
SpO2) and Infant Follow-up Form, FLACC pain scale.
Independent Variables: Baby's age, gender. Sampling inclusion criteria
- The baby is between 2 and 12 months
- Suspicion/diagnosis of urinary tract infection being followed
- The baby/child does not have a vision or hearing problem (sight-hearing screening tests
have been completed)
- Not taking drugs containing analgesics in the last 4 hours before the procedure
- Parents' willingness to participate in the research
- It has been determined as the appropriate cognitive level and motor development of
infants/children.
Exclusion criteria
- Mentally or neurologically handicapped
- Having a life-threatening illness
- Babies who failed the procedure, took longer than 3 minutes and needed to be repeated
were excluded from the sample.
Data were collected using the Baby Monitoring Form, monitor and sphygmomanometer Infant
Follow-up Form: After the written Informed Consent Form (Appendix-1) was obtained from the
parents of the infants who met the conditions for participation in the study, stating that
they volunteered to participate in the study, the data were collected by the researcher,
questioning the age, gender, current complaint, whether the procedure was performed before,
and his reaction to the procedure. 7 questions were collected with the Infant Follow-up Form,
which included physiological parameters (pulse, blood pressure, SpO2, respiratory rate) and
the FLACC pain scale (Appendix-2).
FLACC Pain Scale: It is an observational behavioral pain scale used in infants and children
who cannot express their pain verbally. It is used for babies and children aged 2 months to 7
years. It consists of five categories that measure the baby's facial expression, leg
movements, activity, crying, and comfortability. Each of the categories is scored between
0-2, and a total score of 0-10 is obtained, and an increase in the score indicates that the
pain also increases. The total score according to the scoring system made after the
observation; 0: comfortable, calm, comfortable, 1-3: mildly uncomfortable or mild pain, 4-6:
moderate pain, 7-10: significant severe discomfort or significant severe pain, or both. The
FLACC pain scale was evaluated independently by two different observers.
Bedside Monitor Device: A COVIDIEN Nellcor brand monitor was used to measure the patient's
pulse and SpO2.
Blood pressure monitor: A Unitest brand digital sphygmomanometer with a cuff compatible with
the baby was used.
Finger Puppet: Fish-shaped finger puppet made of red fabric is used. Families of infants who
were admitted to the emergency department and followed up with the diagnosis/suspect of
urinary tract infection were informed about the study by face-to-face interview technique,
and the informed consent form prepared by the researcher was read and permission was
obtained. Out of 80 infants aged 2-12 months, 40 infants (intervention group: finger puppet
group) and 40 infants (control group) were divided into two groups. In order to assign the
babies to the groups randomly, between the dates of the study, the babies who would be
treated on odd number days of the calendar formed the group to be treated with finger
puppets, and the baby who was treated on even number days constituted the control group.
First of all, the procedure to be done was explained to the family. Written and verbal
consent was obtained after giving information about the study. During the procedure, the
family was informed that only the mother, the physician performing the procedure, the
researcher and the observer nurses would be present in the room.
Urine culture with the urinary catheterization method is a procedure performed by the
physician under sterile conditions for approximately 1-3 minutes. A finger puppet was played
by the researcher nurse in the intervention group by singing the red fish song in order to
manage the pain during the invasive procedure and to distract the baby's attention.
Initiative Group (Finger Puppet Played Group)
- The baby to be treated was taken to the intervention room by the research nurse.
- Before the procedure, the baby's pulse, blood pressure, SpO2, respiratory rate will be
checked by an observing nurse and recorded on the Baby Monitoring Form.
- Before the procedure, the infant was recorded in the Infant Follow-up Form by evaluating
the FLAAC pain scale independently by both observer nurses.
- 5 minutes before the start of the procedure, a red fish-shaped finger puppet was started
to be played by the research nurse by singing the red fish song from a distance of
approximately 20-30 cm.
- An observer nurse will assist the physician at the beginning of the procedure, and then
gently hold the infant by the upper legs to maintain the stability of the infant and
ensure that the physician can see the urethral opening. The other observer nurse
evaluated the respiratory rate of the baby during the procedure and recorded it in the
Infant Follow-up Form after the procedure was completed.
- During the procedure, the baby was independently evaluated according to the FLAAC pain
scale by both observer nurses.
- The research nurse will continue to play finger puppets for 5 more minutes after the end
of the procedure, and the puppet play was terminated after 5 minutes.
- Immediately after the procedure and five minutes later, the baby's pulse, blood
pressure, SpO2, respiratory rate will be checked and the baby's pain was evaluated by
both observer nurses according to the FLAAC pain scale, recorded in the Baby Monitoring
Form, and then the baby was delivered to the family.
- During the procedure, no pharmacological or non-pharmacological interventions were made
for the baby's pain, and no attempts were made to distract the baby's attention except
finger puppets
Control group:
- The baby to be treated was taken to the intervention room by the research nurse.
- Before the procedure, the baby's pulse, blood pressure, SpO2, respiratory rate were
checked by an observing nurse and recorded on the Baby Monitoring Form.
- An observer nurse will assist the doctor at the beginning of the procedure, and then the
baby's upper legs are kept stable in order to maintain the stability of the baby and
ensure that the doctor can see the urethral opening. The other observer nurse evaluated
the respiratory rate of the baby during the procedure and recorded it in the Infant
Follow-up Form after the procedure was completed.
- During the procedure, the baby was evaluated by both observer nurses according to the
FLAAC pain scale.
- No pharmacological or non-pharmacological interventions were made for the baby's pain
during the procedure.
- Immediately after the procedure and 5 minutes later, the baby's pulse, blood pressure,
SpO2, respiratory rate were checked and recorded, and both observer nurses independently
evaluated the baby's pain according to the FLAAC Pain Scale and recorded it in the Baby
Monitoring Form, and then the baby was delivered to the family.
The quantitative data obtained in the research will be analyzed in the computer environment
after data entry is made in the SPSS 21.0 package program. Number, percentage, mean and
standard deviation were used as descriptive statistical methods in the evaluation of the
data. Before the data analysis, the normality test was performed to test the suitability for
the parametric test methods. In order to test the normal distribution condition,
Kolmogorov-Smirnov Z test was applied. Chi-square and fisherexact tests were applied to
determine the homogeneity of the groups. Whether there is a statistical difference between
the groups, repeated measurements; Pairwise comparison was evaluated with Independent group
t-test. The findings were evaluated at 95% confidence interval and 5% significance level. It
was stated that there was a significant difference between the groups when p<0.05, and there
was no significant difference in case of p>0.05.
Before starting the research, ethics committee approval from the Research Zeynep Kamil
Gynecology and Pediatrics Training and Research Hospital Ethics Committee , Master's Thesis
Work Permit from Istanbul Provincial Health Directorate , translation of FLACC Pain Scale
into Turkish was required. necessary permissions were obtained.
After the parents of the infants included in the study were informed about the study, their
written consent was obtained with the "Informed Voluntary Consent Form" .
