NCT05412719

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
Last Updated

June 9, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

May 13, 2022

Last Update Submit

June 7, 2022

Conditions

Keywords

pain, infants

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.

Behavioral: THE EFFECT OF FINGER PUPPET MANIPULATION ON PAİN AND PHYSİOLOGıCAL PARAMETERS DURING URINARY CULTURE WITH URINARY CATHETERIZATION IN INFANTS

intervention group

EXPERIMENTAL

Before 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

Behavioral: THE EFFECT OF FINGER PUPPET MANIPULATION ON PAİN AND PHYSİOLOGıCAL PARAMETERS DURING URINARY CULTURE WITH URINARY CATHETERIZATION IN INFANTS

Interventions

the effect of finger puppet manipulation on pain and physiological parameters during urinary culture with urinary catheterization

Also known as: the effect of finger puppet manipulation on pain and physiological parameters during urinary culture with urinary catheterization
control groupintervention group

Eligibility Criteria

Age2 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Study Sites (1)

Okan University

Istanbul, Tuzla, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Urinary Catheterization

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, UrologicalDiagnostic Techniques and ProceduresDiagnosisCatheterizationTherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled two groups (control group and intervention group)
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

Locations