- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05442619
Developing a Portable Therapeutic Baby Nest for Newborns and Evaluation During Venous Blood Collection
Developing a Portable Therapeutic Baby Nest for Newborns and Evaluation of the Effect on Comfort and Pain Levels During Venous Blood Collection
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey, 06080
- Dr. Sami Ulus Maternity and Child Health and Diseases Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 37-42 weeks of gestation,
- Birth weight between 2500-4000 g,
- Being less than 28 postnatal days,
- The family can speak and understand Turkish,
- Newborns with written and verbal informed consent from their families
Exclusion Criteria:
- Having an analgesic intake 4 hours before, which may affect their comfort and behavior
- Presence of congenital anomaly,
- Having respiratory distress,
- Newborns with clinically unstable (vital and physical examination findings)
- Newborns with suspected or diagnosed Covid 19
- Newborns with vision and hearing problems
- Inability to perform blood collection at once
- Newborns have a history of hospitalization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Portable therapeutic baby nest group
Blood will be drawn from newborns using the portable therapeutic baby nest.
|
Venous blood will be drawn from newborns.
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Active Comparator: Control group
Blood collection from newborns will be done according to the clinical routine.
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Venous blood will be drawn from newborns.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prosedural Pain
Time Frame: In each infant, the level of pain will be evaluated in an average of 6 minutes.
|
"The Neonatal-Infant Pain (NIPS) Scale" will be used to measure the pain levels of newborns during the blood collection. Neonatal Infant Pain Scale (NIPS): The Neonatal Infant Pain Scale (NIPS), developed by Lawrence et al. (1993), is a behavioral scale and can be used with both full-term and preterm infants. In NIPS, five behavioral indicators (facial expression, cry, arms, legs, and state of arousal) and one physiological parameter (breathing pattern) are assessed. The total pain score ranges between 0 and 7 with 0-2 points indicating mild to no pain, 3-4 indicating mild to moderate pain, and greater than 4 indicating severe pain (Lawrence et al., 1993). The scale was adapted to Turkish. Cronbach alpha internal consistency coefficient was found between 0.83 and 0.86 (Akdovan et al., 1999). |
In each infant, the level of pain will be evaluated in an average of 6 minutes.
|
Comfort
Time Frame: In each infant, the level of comfort will be evaluated in an average of 6 minutes.
|
"COMFORTneo Scale" will be used to measure the comfort levels of newborns during the blood collection. COMFORTneo Scale: The COMFORTneo scale is used to assess the comfort levels of infants. This scale is a Likert-type scale consisting of seven parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tonus. The lowest score on the scale is 6 and the highest is 30. If the total score of the scale is between 14 and 30, the infant has pain or distress, is uncomfortable, and needs intervention to provide comfort. The validity and reliability study of the Turkish version of the scale was conducted. Cronbach's alpha coefficient of the scale was 0.82-0.92 (Kahraman et al., 2014). |
In each infant, the level of comfort will be evaluated in an average of 6 minutes.
|
Physiological parameters- Pulse rate
Time Frame: In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes.
|
Pulse oximeter will be used to record data about pulse rate (beats/minute).Pulse rate will be recorded under the titles of 2 minute before the procedure, during the procedure (during the blood collection), and 2 minutes after the procedure; Total duration (of the procedure) will be recorded in seconds.
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In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes.
|
Physiological parameters- Oxygen saturation
Time Frame: In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes
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Pulse oximeter will be used to record data about oxygen saturation (SpO2).Oxygen saturation will be recorded under the titles of 2 minute before the procedure, during the procedure (during the blood collection), and 2 minutes after the procedure; Total duration (of the procedure) will be recorded in seconds.
|
In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes
|
Physiological parameters-Respiration rate
Time Frame: In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes
|
A smartphone stopwatch will be used to measure respiratory rate (breaths/minute).
Respiratory rate will be recorded under the titles of 2 minute before the procedure, during the procedure (during the blood collection), and 2 minutes after the procedure; Total duration (of the procedure) will be recorded in seconds.
|
In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.
- van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 56786525-050.04.04/385491
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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