Trial Outcomes & Findings for Crochet Octopus in The Process of Heel Lance in Neonates (NCT NCT04560374)
NCT ID: NCT04560374
Last Updated: 2021-05-18
Results Overview
Neonate Infant Pain Scale score calculated before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus. It is a 6-itemed scale developed to assess the pain occuring due to interventions implemented to term and premature infants. The scoring of the scale was realized by assessing five behavioral classification (mimics, crying, movements of arms and legs, wakefulness state) and one physological parameter (type of respiration). It needs too much time and is difficult to assess intubated infants. It is suitable for painful conditions of non-intubated infants . Total score calculated. The lowest score of the scale is 0; the highest one is 7 and 3+ score shows the presence of pain.
COMPLETED
NA
100 participants
Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)
2021-05-18
Participant Flow
Participant milestones
| Measure |
Experimental Group
Crochet octopus was delivered to the hands of the neonates in the experimental group 10 minutes before heel lance process and they were contacted with the crochet octopus up to 10 minutes after the procedure.
|
Control Group
Control group neonates were performed all the process without delivering them any crochet octopus.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group
n=50 Participants
All neonates who was delivered to the hands crochet octopus during data collection process
|
Control Group
n=50 Participants
All neonates who was not delivered to the hands crochet octopus during data collection process
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Neonate's Age (day)
|
8 days
n=50 Participants
|
8 days
n=50 Participants
|
8 days
n=100 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=50 Participants
|
27 Participants
n=50 Participants
|
57 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=50 Participants
|
23 Participants
n=50 Participants
|
43 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
100 Participants
n=100 Participants
|
|
Neonatal Infant Pain Score
|
0 scale score
n=50 Participants
|
1 scale score
n=50 Participants
|
0 scale score
n=100 Participants
|
PRIMARY outcome
Timeframe: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)Neonate Infant Pain Scale score calculated before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus. It is a 6-itemed scale developed to assess the pain occuring due to interventions implemented to term and premature infants. The scoring of the scale was realized by assessing five behavioral classification (mimics, crying, movements of arms and legs, wakefulness state) and one physological parameter (type of respiration). It needs too much time and is difficult to assess intubated infants. It is suitable for painful conditions of non-intubated infants . Total score calculated. The lowest score of the scale is 0; the highest one is 7 and 3+ score shows the presence of pain.
Outcome measures
| Measure |
Experimental Group
n=50 Participants
Crochet octopus was delivered to the hands of the neonates in the experimental group 10 minutes before heel lance process and they were contacted with the crochet octopus up to 10 minutes after the procedure.
|
Control Group
n=50 Participants
Control group neonates were performed all the process without delivering them any crochet octopus.
|
|---|---|---|
|
Neonate Infant Pain Scale Score
Before procedure (0th min.)
|
0 score on a scale
Interval 0.0 to 1.0
|
1 score on a scale
Interval 0.0 to 1.0
|
|
Neonate Infant Pain Scale Score
During procedure
|
4 score on a scale
Interval 3.0 to 5.0
|
4 score on a scale
Interval 3.0 to 5.0
|
|
Neonate Infant Pain Scale Score
After procedure (2nd min)
|
0 score on a scale
Interval 0.0 to 1.25
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Neonate Infant Pain Scale Score
After procedure (10th min)
|
0 score on a scale
Interval 0.0 to 0.0
|
1 score on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)Duration of crying counted before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus.
Outcome measures
| Measure |
Experimental Group
n=50 Participants
Crochet octopus was delivered to the hands of the neonates in the experimental group 10 minutes before heel lance process and they were contacted with the crochet octopus up to 10 minutes after the procedure.
|
Control Group
n=50 Participants
Control group neonates were performed all the process without delivering them any crochet octopus.
|
|---|---|---|
|
Duration of Crying
Before procedure (0th min.)
|
0 second
Interval 0.0 to 0.0
|
10 second
Interval 0.0 to 32.5
|
|
Duration of Crying
During procedure
|
55 second
Interval 31.5 to 80.25
|
60.50 second
Interval 53.0 to 91.0
|
|
Duration of Crying
After procedure (2nd min)
|
0 second
Interval 0.0 to 20.0
|
33 second
Interval 15.0 to 60.0
|
|
Duration of Crying
After procedure (10 th min)
|
0 second
Interval 0.0 to 0.0
|
0 second
Interval 0.0 to 23.5
|
Adverse Events
Experimental Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Çağrı Çövener Özçelik
Marmara University Faculty of Health Sciences Department of Pediatric Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place