Okan University
Istanbul, Tuzla, Turkey (Türkiye)
NCT Number: NCT05412719
. 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.
Looking for future studies?
Notify Me2 month–12 month
All sexes
Interventional
Not applicable
Istanbul, Tuzla, Turkey (Türkiye)
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
Exclusion criteria
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)
Control group:
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" .
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mentally or neurologically handicapped
the effect of finger puppet manipulation on pain and physiological parameters during urinary culture with urinary catheterization
Other names: the effect of finger puppet manipulation on pain and physiological parameters during urinary culture with urinary catheterization
Time frame: before urinary catheter intervention(5 minutes ago)
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. A total of 0-10 points are obtained in the scale, where each of the categories is scored between 0-2, and the increase in the score indicates that the pain also increases. According to the scoring system made after the observation, the total score is 0: the child is comfortable, calm, comfortable, 1-3: slightly uncomfortable. or mild pain, 4-6: moderate pain, 7-10: significant severe discomfort or significant severe pain, or both.
Time frame: urinary catheter attempt sequence (0th minute)
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. A total of 0-10 points are obtained in the scale, where each of the categories is scored between 0-2, and the increase in the score indicates that the pain also increases. According to the scoring system made after the observation, the total score is 0: the child is comfortable, calm, comfortable, 1-3: slightly uncomfortable. or mild pain, 4-6: moderate pain, 7-10: significant severe discomfort or significant severe pain, or both.
Time frame: immediately after urinary catheter interventioan (0th minute)
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. A total of 0-10 points are obtained in the scale, where each of the categories is scored between 0-2, and the increase in the score indicates that the pain also increases. According to the scoring system made after the observation, the total score is 0: the child is comfortable, calm, comfortable, 1-3: slightly uncomfortable. or mild pain, 4-6: moderate pain, 7-10: significant severe discomfort or significant severe pain, or both.
Time frame: 5 minutes after urinary catheterization
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. A total of 0-10 points are obtained in the scale, where each of the categories is scored between 0-2, and the increase in the score indicates that the pain also increases. According to the scoring system made after the observation, the total score is 0: the child is comfortable, calm, comfortable, 1-3: slightly uncomfortable. or mild pain, 4-6: moderate pain, 7-10: significant severe discomfort or significant severe pain, or both.
Time frame: before urinary catheter intervention(5 minutes ago)
SPO2 (%) were evaluated
Time frame: urinary catheter attempt sequence (0th minute)
SPO2 (%) were evaluated
Time frame: immediately after urinary catheter interventioan (0th minute)
SPO2 (%) were evaluated
Time frame: 5 minutes after urinary catheterization
SPO2 (%) were evaluated
Time frame: before urinary catheter intervention(5 minutes ago)
blood pressure (mmHg) were evaluated
Time frame: immediately after urinary catheter interventioan (0th minute)
blood pressure (mmHg) were evaluated
Time frame: 5 minutes after urinary catheterization
blood pressure (mmHg) were evaluated
Time frame: before urinary catheter intervention(5 minutes ago)
heart rate (beats/minute) were evaluated
Time frame: urinary catheter attempt sequence (0th minute)
heart rate (beats/minute) were evaluated
Time frame: immediately after urinary catheter interventioan (0th minute)
heart rate (beats/minute) were evaluated
Time frame: 5 minutes after urinary catheterization
heart rate (beats/minute) were evaluated
Time frame: before urinary catheter intervention(5 minutes ago)
respiratory rate (beats/minute) were evaluated
Time frame: urinary catheter attempt sequence (0th minute)
respiratory rate (beats/minute) were evaluated
Time frame: immediately after urinary catheter interventioan (0th minute)
respiratory rate (beats/minute) were evaluated
Time frame: 5 minutes after urinary catheterization
respiratory rate (beats/minute) were evaluated
Okan University
Other
The Effect Of Finger Pupiling On Pain And Physiological Parameters During Urinary Culture With Urinary Catheter in İnfants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07025161
Neurologic Manifestations, Pain
Orlando, Florida, United States
View Trial DetailsNCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial DetailsNCT06869369
Behavior, Motor Activity
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT07729020
Anxiety, Anxiety Disorders
Genoa, Liguria, Italy
View Trial Details