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Aim: This study was conducted to determine and compare the effectiveness of different non-pharmacological methods in pain management during vaccination.
Methods: This randomized experimental study with placebo and control groups was conducted with 175 infants assigned to the ShotBlocker® (n = 35), ShotBlocker®-placebo (n = 35), sucrose (n = 35), sucrose-placebo (n = 35) and control (n = 35) groups. The pain levels of the infants were determined by blind assessors (nurses, parents, and observer) using the Neonatal Infant Pain Scale (NIPS) before and during vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Characteristics of newborns included | No Intervention | Characteristics of newborns included in the randomized controll | |
| Intraclass Correlation between the NIPS Score of Parent, Nurse | Experimental | Intraclass Correlation between the NIPS Score of Parent, Nurse |
|
| Comparisons of procedural pain scores among groups | Experimental | Comparisons of procedural pain scores among groups |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparisons of procedural pain | Behavioral | This randomized experimental study with placebo and control groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Infant Pain Scale (NIPS) | NIPS is a valid behavioural instrument that can be used to assess infants' response to pain. NIPS includes six behavioural responses to pain: facial expression, crying, breathing patterns, arms, legs, and state of wakefulness. The total pain scores range from 0 to 7. While the internal consistency of the original NIPS is within the range of .87 to .95, the internal consistency of the Turkish version is .83 | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| İnonu Üniversity | Malatya | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This study was designed as a randomized experimental study with placebo and control groups in order to compare the effects of ShotBlocker® and sucrose on pain reduction during vaccine injections.
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In the study, a multi-stage randomization method was used as follows: 1) random selection of the family health centres in the city in which the research was conducted; 2) selection of the mothers and infants to be included in the study at each centre; and 3) selection of the groups to which the participants were assigned using a computer-based block randomization method (https://www.randomizer.org). The infants, randomized via a computer system, were assigned to the ShotBlocker® group (n= 35), ShotBlocker®-placebo group (n = 35), sucrose group (n = 35), sucrose-placebo group (n = 35), or the control group (n=35).