The Effectiveness of the Therapeutic Toys During Intravenous Canula Insertion

NCT ID: NCT05839184

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2023-05-13

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.

Conditions

Pain, Acute; Comfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

CONTROL GROUP

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

therapeutic toy GROUP

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.

Group Type: ACTIVE_COMPARATOR

therapeutic toy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Can Hospital

UNKNOWN

Sponsor Role: collaborator

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

ESRA ARDAHAN AKGUL

Assistant Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esra ARDAHAN AKGÜL, Asst. Prof.

Role: STUDY_CHAIR

İzmir Katip Çelebi University

Locations

Katip Celebi University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

132

Identifier Type: -

Identifier Source: org_study_id