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The Effectiveness of the Therapeutic Toys During Intravenous Canula Insertion

Primary Purpose

Pain, Acute, Comfort

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
therapeutic toy
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Acute focused on measuring pain, comfort

Eligibility Criteria

1 Day - 28 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Parent's approval to participate in the study Born older than 24th gestational week The baby is hospitalized in the Neonatal Intensive Care Clinic Need for opening an IV catheter A saturation value above 90% before the invasive procedure Heart rate between 120-160 beats/min before the invasive procedure Respiratory rate between 30-60 breaths/min before invasive procedure Ability to open an IV road on the first attempt Exclusion Criteria: The parent is not willing to participate in the study The baby is taking any medication that affects the comfort level Being monitored with mechanical ventilation Failure to open an IV road on the first attempt

Sites / Locations

  • Katip Celebi University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

CONTROL GROUP

therapeutic toy GROUP

Arm Description

All newborns in the study will be monitored during IV catheter placement. Newborns in the control group will not be given any therapeutic toy and IV catheter will be placed and their comfort levels and vital signs will be monitored.

All newborns in the study will be monitored during IV catheter placement. Newborns in the therapeutic toy group will be given an octopus-shaped therapeutic toy that they can hold in their hands throughout the procedure and IV catheter will be inserted and their comfort levels and vital signs will be monitored.

Outcomes

Primary Outcome Measures

COMFORT LEVEL
The Neonatal Comfort Scale was developed by Ambuel et al., revised by van Dijk et al. and validated in Turkish by Kahraman et al. in 2014. The scores that can be obtained from the Neonatal Comfort Behavior Scale vary between 6-30. A higher score means that the newborn is not comfortable and needs interventions to provide comfort.
COMFORT LEVEL
The Neonatal Comfort Scale was developed by Ambuel et al., revised by van Dijk et al. and validated in Turkish by Kahraman et al. in 2014. The scores that can be obtained from the Neonatal Comfort Behavior Scale vary between 6-30. A higher score means that the newborn is not comfortable and needs interventions to provide comfort.
COMFORT LEVEL
The Neonatal Comfort Scale was developed by Ambuel et al., revised by van Dijk et al. and validated in Turkish by Kahraman et al. in 2014. The scores that can be obtained from the Neonatal Comfort Behavior Scale vary between 6-30. A higher score means that the newborn is not comfortable and needs interventions to provide comfort.
BREATHE PER MINUTE
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
BREATHE PER MINUTE
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
BREATHE PER MINUTE
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
HEARTH RATE PER MINUTE
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
HEARTH RATE PER MINUTE
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
HEARTH RATE PER MINUTE
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
OXYGEN SATURATION
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
OXYGEN SATURATION
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
OXYGEN SATURATION
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.

Secondary Outcome Measures

DURATION OF CRYING
During the IV catheter insertion process, the time will be measured with a stopwatch from the first moment the baby cries until the last moment.

Full Information

First Posted
April 18, 2023
Last Updated
June 19, 2023
Sponsor
Izmir Katip Celebi University
Collaborators
Izmir Can Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05839184
Brief Title
The Effectiveness of the Therapeutic Toys During Intravenous Canula Insertion
Official Title
The Effectiveness of the Therapeutic Toys on the Comfort Level of the Infants During Intravenous Canula Insertion
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
May 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University
Collaborators
Izmir Can Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pain relief interventions in invasive interventions are divided into two pharmacologic methods and non-pharmacologic methods. Nonpharmacologic interventions are an area where nurses can easily demonstrate their independent roles. Especially today, when the use of complementary and alternative medicine (CAM) methods is increasing, nurses are also turning to these methods. Non-pharmacological methods include listening to white noise, non-nutritive sucking, aromatherapy applications, placing the baby on the mother's lap, changing position, rocking, touching, distracting, listening to music, watching cartoons, singing, breastfeeding and giving sucrose solution with breast milk, giving toys and smelling mother odour. This study was planned to determine the effect of the therapeutic toy used during IV catheter placement, which is the most common invasive intervention in the Neonatal Care Unit where a newborn baby is hospitalized, on the comfort level, crying time and physiological parameters of the newborn.
Detailed Description
Comfort is defined as "the expected result with a complex structure within biopsychosocial and environmental integrity in order to provide help, peace of mind and cope with problems related to one's needs". According to Kolcaba, comfort is the experience of relief, peace of mind and meeting needs to solve problems. The term comfort has been frequently used in recent years for infants receiving health care in Neonatal and Neonatal Surgery Intensive Care Units. Physical characteristics of the clinic, immaturity of newborns, frequent routine care and invasive procedures (burn dressing, hydrotherapy, blood collection, IV catheter insertion, heel prick, aspiration, nasogastric catheter insertion, foley catheter insertion, rectal tube insertion, neonatal eye examination) cause a decrease in the comfort of newborns. As a result of rapidly increasing technological developments, changes are also seen in the neonatal discipline and perinatal mortality rates are decreasing, especially in developing countries. As a result of this development, survival rates of very low birth weight newborns have increased to 85%. Although mortality has decreased in preterm infants, neurodevelopmental, pulmonary and cardiac problems have increased. When the causes of neurodevelopmental problems in preterm infants are examined, it is seen that in addition to retinopathy, systemic infections, nutritional problems due to necrotizing enterocolitis and similar causes, intracranial haemorrhage, there are also stressors such as invasive procedures, pain, noise and light that the newborn is exposed to in the intensive care unit. Stress has negative effects on neurodevelopment. Newborns who have not reached neurodevelopmental maturity begin to experience stress when they leave their warm, dark, quiet and calm environments that contribute to their brain development and start to receive health care in intensive care units where they are exposed to noisy, light and painful procedures. This stress and invasive sensory experiences are thought to suppress the development of cell migration, synaptogenesis, myelinization and organizational structures in the infant's nervous system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Comfort
Keywords
pain, comfort

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
All newborns in the study will be monitored during IV catheter placement. Newborns in the control group will not be given any therapeutic toy and IV catheter will be placed and their comfort levels and vital signs will be monitored.
Arm Title
therapeutic toy GROUP
Arm Type
Active Comparator
Arm Description
All newborns in the study will be monitored during IV catheter placement. Newborns in the therapeutic toy group will be given an octopus-shaped therapeutic toy that they can hold in their hands throughout the procedure and IV catheter will be inserted and their comfort levels and vital signs will be monitored.
Intervention Type
Device
Intervention Name(s)
therapeutic toy
Intervention Description
Neonates in the therapeutic toy group will be given an octopus-shaped therapeutic toy that they can hold in their hands throughout the procedure and IV catheter will be inserted and their comfort levels and vital signs will be monitored.
Primary Outcome Measure Information:
Title
COMFORT LEVEL
Description
The Neonatal Comfort Scale was developed by Ambuel et al., revised by van Dijk et al. and validated in Turkish by Kahraman et al. in 2014. The scores that can be obtained from the Neonatal Comfort Behavior Scale vary between 6-30. A higher score means that the newborn is not comfortable and needs interventions to provide comfort.
Time Frame
immediately after the IV catheter insertion,
Title
COMFORT LEVEL
Description
The Neonatal Comfort Scale was developed by Ambuel et al., revised by van Dijk et al. and validated in Turkish by Kahraman et al. in 2014. The scores that can be obtained from the Neonatal Comfort Behavior Scale vary between 6-30. A higher score means that the newborn is not comfortable and needs interventions to provide comfort.
Time Frame
1st minute after the IV catheter insertion
Title
COMFORT LEVEL
Description
The Neonatal Comfort Scale was developed by Ambuel et al., revised by van Dijk et al. and validated in Turkish by Kahraman et al. in 2014. The scores that can be obtained from the Neonatal Comfort Behavior Scale vary between 6-30. A higher score means that the newborn is not comfortable and needs interventions to provide comfort.
Time Frame
5th minute after the IV catheter insertion
Title
BREATHE PER MINUTE
Description
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
Time Frame
immediately after the IV catheter insertion
Title
BREATHE PER MINUTE
Description
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
Time Frame
1st minute after the IV catheter insertion
Title
BREATHE PER MINUTE
Description
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
Time Frame
5th minute after the IV catheter insertion
Title
HEARTH RATE PER MINUTE
Description
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
Time Frame
immediately after the IV catheter insertion
Title
HEARTH RATE PER MINUTE
Description
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
Time Frame
1st minute after the IV catheter insertion
Title
HEARTH RATE PER MINUTE
Description
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
Time Frame
5th minute after the IV catheter insertion
Title
OXYGEN SATURATION
Description
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
Time Frame
immediately after the IV catheter insertion
Title
OXYGEN SATURATION
Description
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
Time Frame
1st minute after the IV catheter insertion
Title
OXYGEN SATURATION
Description
The form was created by the researchers by reviewing the literature in order to collect physiological parameter data just before the intervention was applied to the newborn, when the intervention started and 1 minute and 5 minutes after the intervention ended.
Time Frame
5th minute after the IV catheter insertion
Secondary Outcome Measure Information:
Title
DURATION OF CRYING
Description
During the IV catheter insertion process, the time will be measured with a stopwatch from the first moment the baby cries until the last moment.
Time Frame
Procedure (During the IV catheter insertion process)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parent's approval to participate in the study Born older than 24th gestational week The baby is hospitalized in the Neonatal Intensive Care Clinic Need for opening an IV catheter A saturation value above 90% before the invasive procedure Heart rate between 120-160 beats/min before the invasive procedure Respiratory rate between 30-60 breaths/min before invasive procedure Ability to open an IV road on the first attempt Exclusion Criteria: The parent is not willing to participate in the study The baby is taking any medication that affects the comfort level Being monitored with mechanical ventilation Failure to open an IV road on the first attempt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra ARDAHAN AKGÜL, Asst. Prof.
Organizational Affiliation
İzmir Katip Çelebi University
Official's Role
Study Chair
Facility Information:
Facility Name
Katip Celebi University
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effectiveness of the Therapeutic Toys During Intravenous Canula Insertion

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