The Effect Of Finger Pupiling On Pain And Physiological Parameters in İnfants
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 13, 2022
CompletedFirst Posted
Study publicly available on registry
June 9, 2022
CompletedJune 9, 2022
May 1, 2022
1 year
May 13, 2022
June 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (19)
pain score
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.
before urinary catheter intervention(5 minutes ago)
pain score
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.
urinary catheter attempt sequence (0th minute)
pain score
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.
immediately after urinary catheter interventioan (0th minute)
pain score
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.
5 minutes after urinary catheterization
SPO2 vital signs
SPO2 (%) were evaluated
before urinary catheter intervention(5 minutes ago)
SPO2 vital signs
SPO2 (%) were evaluated
urinary catheter attempt sequence (0th minute)
SPO2 vital signs
SPO2 (%) were evaluated
immediately after urinary catheter interventioan (0th minute)
SPO2 vital signs
SPO2 (%) were evaluated
5 minutes after urinary catheterization
blood pressure vital signs
blood pressure (mmHg) were evaluated
before urinary catheter intervention(5 minutes ago)
blood pressure vital signs
blood pressure (mmHg) were evaluated
immediately after urinary catheter interventioan (0th minute)
blood pressure vital signs
blood pressure (mmHg) were evaluated
5 minutes after urinary catheterization
heart rate vital signs
heart rate (beats/minute) were evaluated
before urinary catheter intervention(5 minutes ago)
heart rate vital signs
heart rate (beats/minute) were evaluated
urinary catheter attempt sequence (0th minute)
heart rate vital signs
heart rate (beats/minute) were evaluated
immediately after urinary catheter interventioan (0th minute)
heart rate vital signs
heart rate (beats/minute) were evaluated
5 minutes after urinary catheterization
respiratory rate vital signs
respiratory rate (beats/minute) were evaluated
before urinary catheter intervention(5 minutes ago)
respiratory rate vital signs
respiratory rate (beats/minute) were evaluated
urinary catheter attempt sequence (0th minute)
respiratory rate vital signs
respiratory rate (beats/minute) were evaluated
immediately after urinary catheter interventioan (0th minute)
respiratory rate vital signs
respiratory rate (beats/minute) were evaluated
5 minutes after urinary catheterization
Study Arms (2)
control group
EXPERIMENTAL. 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.
intervention group
EXPERIMENTALBefore the procedure, the baby's heart rate, blood pressure, spo2, respiratory rate, FLACC were recorded, 5 minutes before the procedure, the finger puppet was started to be played by singing the red fish song, the baby's pulse, spo2, respiratory rate and FLACC scale were recorded during the procedure, 5 minutes after the procedure Playing more finger puppetry Evaluation of the baby's pulse, blood pressure, spo2, respiratory rate and FLAAC immediately after the procedure and five minutes later
Interventions
the effect of finger puppet manipulation on pain and physiological parameters during urinary culture with urinary catheterization
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Okan Universitylead
Study Sites (1)
Okan University
Istanbul, Tuzla, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- duygu çiçek
Study Record Dates
First Submitted
May 13, 2022
First Posted
June 9, 2022
Study Start
February 1, 2021
Primary Completion
February 1, 2022
Study Completion
February 1, 2022
Last Updated
June 9, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share