Pain, AcuteNCT05839184
The Effectiveness of the Therapeutic Toys During Intravenous Canula Insertion
A study testing therapeutic toy in people with Pain, Acute and Comfort, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Pain, Acute, Comfort
- What is being tested?
- therapeutic toy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2023to 13 May 2023
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of the Therapeutic Toys on the Comfort Level of the Infants During Intravenous Canula Insertion
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.
Read the 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
- Being tested
- therapeutic toy
- Keywords
- pain, comfort
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic toyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: therapeutic toy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5th minute after the IV catheter insertion
Secondary outcomes (1)
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.
Measured: Procedure (During the IV catheter insertion process)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start20 Apr 2023
- Primary completion10 May 2023
- Study completion13 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Can Hospital
- Responsible party
- Principal investigator, ESRA ARDAHAN AKGUL, Izmir Katip Celebi University
- Investigators
- Esra ARDAHAN AKGÜL, Asst. Prof., Study chair, İzmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839184
- Sponsor's protocol ID
- 132
- Status last verified
- Jun 2023
- First submitted
- 18 Apr 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Therapeutic Toys on the Comfort Level of the Infants During Intravenous Canula Insertion
- ClinicalTrials.gov ID
- NCT05839184
- Acronym / sponsor ID
- 132
- Conditions
- Pain, Acute, Comfort
- Keywords
- pain, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Izmir Can Hospital
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 13 May 2023 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised controlled
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: therapeutic toyAll 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. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic toyNeonates 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 GROUP |
Primary outcome
COMFORT LEVEL
Time frame: immediately after the IV catheter insertion,
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
Time frame: 1st minute after the IV catheter insertion
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
Time frame: 5th minute after the IV catheter insertion
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
Time frame: immediately after the IV catheter insertion
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
Time frame: 1st minute after the IV catheter insertion
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
Time frame: 5th minute after the IV catheter insertion
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
Time frame: immediately after the IV catheter insertion
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
Time frame: 1st minute after the IV catheter insertion
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
Time frame: 5th minute after the IV catheter insertion
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
Time frame: immediately after the IV catheter insertion
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
Time frame: 1st minute after the IV catheter insertion
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
Time frame: 5th minute after the IV catheter insertion
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.
1 secondary outcome
DURATION OF CRYING
Time frame: Procedure (During the IV catheter insertion process)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra ARDAHAN AKGÜL, Asst. Prof. study chair
İzmir Katip Çelebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic toy in people with Pain, Acute and Comfort, run by Izmir Katip Celebi 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 8 inclusion and 4 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 22 Jun 2023. 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?
COMFORT LEVEL (time frame: immediately after the IV catheter insertion,). The study lists 12 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 22 Jun 2023.