The Effectiveness of the Therapeutic Toys During Intravenous Canula Insertion

NCT05839184 | Completed

• 1 other identifier: 132
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Comfort

Keywords

pain, comfort

Outcome Measures

Primary Outcomes (12)

• 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,

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• DURATION OF CRYING

  Procedure (During the IV catheter insertion process)

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

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.

therapeutic toy GROUP

ACTIVE COMPARATOR

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.

Device: therapeutic toy

Interventions

therapeutic toy DEVICE

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.

therapeutic toy GROUP

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• Izmir Can Hospital: collaborator

Study Sites (1)

Katip Celebi University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esra ARDAHAN AKGÜL, Asst. Prof.

  İzmir Katip Çelebi University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Model Details: randomised controlled

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 3, 2023
• Study Start: April 20, 2023
• Primary Completion: May 10, 2023
• Study Completion: May 13, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)