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PainNCT05412719

The Effect Of Finger Pupiling On Pain And Physiological Parameters in İnfants

A study testing THE EFFECT OF FINGER PUPPET MANIPULATION ON PAİN AND PHYSİOLOGıCAL PARAMETERS DURING URINARY CULTURE WITH URINARY CATHETERIZATION IN INFANTS in people with Pain, run by Okan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 2 to 12 monthsHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
THE EFFECT OF FINGER PUPPET MANIPULATION ON PAİN AND PHYSİOLOGıCAL PARAMETERS DURING URINARY CULTURE WITH URINARY CATHETERIZATION IN INFANTS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2021to 1 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 12 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Okan University

    Istanbul, Tuzla

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of Finger Pupiling On Pain And Physiological Parameters During Urinary Culture With Urinary Catheter in İnfants

. 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.

Read the detailed 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" .

Conditions
Pain
Being tested
THE EFFECT OF FINGER PUPPET MANIPULATION ON PAİN AND PHYSİOLOGıCAL PARAMETERS DURING URINARY CULTURE WITH URINARY CATHETERIZATION IN INFANTS
Keywords
pain, infants
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THE EFFECT OF FINGER PUPPET MANIPULATION ON PAİN AND PHYSİOLOGıCAL PARAMETERS DURING URINARY CULTURE WITH URINARY CATHETERIZATION IN INFANTSBehavioural

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

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

Study groups in NCT05412719
Study groupRoleWhat they receive
control groupExperimental. 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.
Receives: Behavioral: THE EFFECT OF FINGER PUPPET MANIPULATION ON PAİN AND PHYSİOLOGıCAL PARAMETERS DURING URINARY CULTURE WITH URINARY CATHETERIZATION IN INFANTS
intervention groupExperimentalBefore 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
Receives: Behavioral: THE EFFECT OF FINGER PUPPET MANIPULATION ON PAİN AND PHYSİOLOGıCAL PARAMETERS DURING URINARY CULTURE WITH URINARY CATHETERIZATION IN INFANTS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: before urinary catheter intervention(5 minutes ago)

  2. 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.

    Measured: urinary catheter attempt sequence (0th minute)

  3. 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.

    Measured: immediately after urinary catheter interventioan (0th minute)

  4. 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.

    Measured: 5 minutes after urinary catheterization

  5. SPO2 vital signs

    SPO2 (%) were evaluated

    Measured: before urinary catheter intervention(5 minutes ago)

  6. SPO2 vital signs

    SPO2 (%) were evaluated

    Measured: urinary catheter attempt sequence (0th minute)

  7. SPO2 vital signs

    SPO2 (%) were evaluated

    Measured: immediately after urinary catheter interventioan (0th minute)

  8. SPO2 vital signs

    SPO2 (%) were evaluated

    Measured: 5 minutes after urinary catheterization

  9. blood pressure vital signs

    blood pressure (mmHg) were evaluated

    Measured: before urinary catheter intervention(5 minutes ago)

  10. blood pressure vital signs

    blood pressure (mmHg) were evaluated

    Measured: immediately after urinary catheter interventioan (0th minute)

  11. blood pressure vital signs

    blood pressure (mmHg) were evaluated

    Measured: 5 minutes after urinary catheterization

  12. heart rate vital signs

    heart rate (beats/minute) were evaluated

    Measured: before urinary catheter intervention(5 minutes ago)

  13. heart rate vital signs

    heart rate (beats/minute) were evaluated

    Measured: urinary catheter attempt sequence (0th minute)

  14. heart rate vital signs

    heart rate (beats/minute) were evaluated

    Measured: immediately after urinary catheter interventioan (0th minute)

  15. heart rate vital signs

    heart rate (beats/minute) were evaluated

    Measured: 5 minutes after urinary catheterization

  16. respiratory rate vital signs

    respiratory rate (beats/minute) were evaluated

    Measured: before urinary catheter intervention(5 minutes ago)

  17. respiratory rate vital signs

    respiratory rate (beats/minute) were evaluated

    Measured: urinary catheter attempt sequence (0th minute)

  18. respiratory rate vital signs

    respiratory rate (beats/minute) were evaluated

    Measured: immediately after urinary catheter interventioan (0th minute)

  19. respiratory rate vital signs

    respiratory rate (beats/minute) were evaluated

    Measured: 5 minutes after urinary catheterization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2022
  2. Study start1 Feb 2021
  3. Primary completion1 Feb 2022
  4. Study completion1 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled two groups (control group and intervention group)
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05412719
Sponsor's protocol ID
2021/210
Status last verified
May 2022
First submitted
13 May 2022
Last updated
9 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing THE EFFECT OF FINGER PUPPET MANIPULATION ON PAİN AND PHYSİOLOGıCAL PARAMETERS DURING URINARY CULTURE WITH URINARY CATHETERIZATION IN INFANTS in people with Pain, run by Okan University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain score (time frame: before urinary catheter intervention(5 minutes ago)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.

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