Procedural Pain
Conditions
Keywords
neonate, pain, heel lance, developmental care
Brief summary
The main objective of the study was to determine the effect of using crochet octopus in order to reduce the acute pain developed during the process of heel lance in neonates. The hypothesis of the study was Crochet octopus is rather effective in reducing the acute pain in heel lance process for neonates.
Detailed description
The study was conducted as randomized controlled. It included term neonates born between May 2020 and August 2020 at a training and research hospital. The study was completed with 100 neonates in total as 50 for experiment and 50 for control groups. During the process of heel lance, experiment group neonates were delivered crochet octopus 10 minutes before the process and let them touch the octopus 10 minutes more after the process. Control group neonates experienced the process without any intervention. As for the data collection, Newborn Identification Form, Neonatal-Infant Pain Scale (NIPS) and Observation Form were utilized. The whole process was video-recorded.
Interventions
DEVICEcrochet octopus
Delivering crochet octopus to the hands of the neonates
Sponsors
Marmara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized controlled study
Eligibility
Sex/Gender
ALL
Age
5 Days to 15 Days
Healthy volunteers
Yes
Inclusion criteria
* being a healthy term neonates, * being 5-15 days, * taking of blood sample for Guthrie test routinely.
Exclusion criteria
* admitted to the neonatal intensive care units * his/her being taken any analgesics prior to the intervention, * having any congenital anomalies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonate Infant Pain Scale Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Crying | 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. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group All neonates who was delivered to the hands crochet octopus during data collection process | 50 |
| Control Group All neonates who was not delivered to the hands crochet octopus during data collection process | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Experimental Group | Control Group | Total |
|---|---|---|---|
| Age, Customized Neonate's Age (day) | 8 days | 8 days | 8 days |
| Neonatal Infant Pain Score | 0 scale score | 1 scale score | 0 scale score |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Turkey | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Female | 30 Participants | 27 Participants | 57 Participants |
| Sex: Female, Male Male | 20 Participants | 23 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Neonate Infant Pain Scale Score
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.
Time frame: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental Group | Neonate Infant Pain Scale Score | Before procedure (0th min.) | 0 score on a scale |
| Experimental Group | Neonate Infant Pain Scale Score | During procedure | 4 score on a scale |
| Experimental Group | Neonate Infant Pain Scale Score | After procedure (2nd min) | 0 score on a scale |
| Experimental Group | Neonate Infant Pain Scale Score | After procedure (10th min) | 0 score on a scale |
| Control Group | Neonate Infant Pain Scale Score | After procedure (10th min) | 1 score on a scale |
| Control Group | Neonate Infant Pain Scale Score | Before procedure (0th min.) | 1 score on a scale |
| Control Group | Neonate Infant Pain Scale Score | After procedure (2nd min) | 2 score on a scale |
| Control Group | Neonate Infant Pain Scale Score | During procedure | 4 score on a scale |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Duration of Crying
Duration of crying counted before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus.
Time frame: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental Group | Duration of Crying | Before procedure (0th min.) | 0 second |
| Experimental Group | Duration of Crying | During procedure | 55 second |
| Experimental Group | Duration of Crying | After procedure (2nd min) | 0 second |
| Experimental Group | Duration of Crying | After procedure (10 th min) | 0 second |
| Control Group | Duration of Crying | After procedure (10 th min) | 0 second |
| Control Group | Duration of Crying | Before procedure (0th min.) | 10 second |
| Control Group | Duration of Crying | After procedure (2nd min) | 33 second |
| Control Group | Duration of Crying | During procedure | 60.50 second |