The Effectiveness of the Therapeutic Toys During Intravenous Canula Insertion

Pain, Acute Clinical Trial

Official title:

The Effectiveness of the Therapeutic Toys on the Comfort Level of the Infants During Intravenous Canula Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05839184
• Other study ID #: 132
• Status: Completed
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: May 13, 2023

Study information

• Verified date: June 2023
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 13, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Comfort
• Pain, Acute

Intervention

Device:
• therapeutic toy
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.

Locations

Country	Name	City	State
Turkey	Katip Celebi University	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Katip Celebi University	Izmir Can Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	immediately after the IV catheter insertion,
Primary	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.	1st minute after the IV catheter insertion
Primary	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.	5th minute after the IV catheter insertion
Primary	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.	immediately after the IV catheter insertion
Primary	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.	1st minute after the IV catheter insertion
Primary	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.	5th minute after the IV catheter insertion
Primary	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.	immediately after the IV catheter insertion
Primary	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.	1st minute after the IV catheter insertion
Primary	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.	5th minute after the IV catheter insertion
Primary	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.	immediately after the IV catheter insertion
Primary	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.	1st minute after the IV catheter insertion
Primary	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.	5th minute after the IV catheter insertion
Secondary	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.	Procedure (During the IV catheter insertion process)