Istanbul University-Cerrahpasa
Istanbul, None Selected, 34381, Turkey (Türkiye)
NCT Number: NCT06291519
This study aimed to investigate the impact of employing the multi-sensory stimulation technique by both the mother and the nurse on the pain and physiological responses of infants aged 2-6 months during vaccination. The significance of pain experienced during vaccination in children is emphasized, potentially leading to avoidance behaviors toward healthcare services. There is growing evidence supporting the efficacy of non-pharmacological interventions. Multi-sensory stimulation, which integrates various stimuli such as taste, touch, and speech, alleviates infant pain. However, there has been a lack of studies assessing the effectiveness of this approach during vaccination administered by different healthcare providers. Hence, this study sought to explore the effects of multi-sensory stimulation by both mother and nurse applied to pain and physiological parameters. It is anticipated that the findings of this study will contribute to both pain management strategies and healthcare practices.
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Notify Me2 month–6 month
All sexes
Interventional
Not applicable
Istanbul, None Selected, 34381, Turkey (Türkiye)
The emergence of needle phobia in childhood often precipitates avoidance behaviors toward vaccinations (McLenon & Rogers, 2019). Mitigating vaccine-induced pain holds promise in alleviating healthcare avoidance inclinations (Komaroff & Forest, 2020). An expanding body of evidence substantiates the efficacy of non-pharmacological interventions in ameliorating acute procedural pain in neonates and infants (Aydın & İnal, 2019; Reece-Stremtan & Gray, 2016).
One such auspicious non-pharmacological approach to pain management is multisensory stimulation, also recognized as sensory saturation. Multisensory stimulation constitutes a non-pharmacological strategy employed to diminish infant pain during acute procedures. Grounded in gate control theory, it postulates that administering both a sweet taste and a spectrum of stimuli to infants may yield heightened analgesic effects (Bellini et al., 2012). The amalgamation of various interventions such as massage, auditory stimuli, olfactory cues, and eye contact via multisensory stimulation engages broader cortical regions and saturates sensory pathways, thereby attenuating nociceptive inputs (Zeraati et al., 2017).
A review of the literature underscores the efficacy of multisensory stimulation as a non-pharmacological modality to alleviate painful procedures in preterm neonates (Anand et al., 2011). Moreover, it demonstrates superior efficacy compared to single pain relief modalities in mitigating pain during venipuncture in infants (Fitri et al., 2020). Despite the demonstrated efficacy of multisensory stimulation as a straightforward, effective, and safe analgesic method during painful neonatal examinations, studies evaluating its effectiveness during vaccine administration are notably absent. Furthermore, scant research has explored the influence of the practitioner (whether mother, nurse, or physician) on the efficacy of this method.
Hypotheses : Babies who underwent the multi-sensory stimulation method; the Pain scale score is lower than the control group, the crying duration is shorter than the control group, the heart rate is lower than the control group, and the saturation (SPO2) is higher than the control group. In the group where the mother is the practitioner of the Multi-sensory stimulation method, compared to the group where the nurse is the practitioner; the pain scale score is low, the crying duration is low, the heart rate is low, saturation level (SPO2) is high.
Aim:
Hence, this study aims to investigate the impact of multisensory stimulation administered by both mothers and nurses on pain perception and physiological parameters during vaccine administration.
Place and Time of the Research:
The data were collected at the Healthy Child Vaccination Unit of a university hospital by visiting the institution two days a week, on Thursdays and Fridays, between January 2023 and December 2023.
Universe and Sample After obtaining the necessary legal permissions (ethics committee approval and institutional permission), the population of the study consisted of infants between the ages of 2-6 months who were applied to the Istanbul University Cerrahpaşa Medical Faculty vaccination room by their mothers for routine vaccination on the dates of the study.
The research sample consisted of 96 infants between the ages of 2-6 months who were brought to the vaccination room between January 2023 and October 2023, met the inclusion criteria, and whose parents gave written informed consent. According to the power analysis, a total of 96 babies were kept safe, 24 babies per group.
Randomization Babies who met the research selection criteria were the group in which the multi-sensory stimulation method was applied, the approved group of the multi-sensory stimulation method, the experimental group, the breastfeeding group, and the control group according to age (2 months, 4 months, 6 months) in which the block randomization method was mostly applied.
Independent variables: Multi-sensory stimulation method Dependent variables: Duration of infant crying, FLACC pain scale score, peak heart rate, saturation (SPO2) level.
Data Collection Method The data were collected by the researcher in the unit where the research was conducted
Data Collection Tools
Procedure The babies included in the study were divided into 4 groups by block randomization method after obtaining ethical and institutional permission. Multi-sensory stimulation method was applied by the mother to the 1st experimental group and by the nurse to the 2nd experimental group. In the breastfeeding group, the mother only breastfed, and no application was applied to the control group.
In all groups, FLACC pain scale, oxygen saturation, and pulse oximetry were evaluated and recorded 5 minutes and 2 minutes before the vaccination process, just before the vaccination, immediately after the vaccination (pain during the procedure), and at the 2nd and 5th minutes after the procedure. Post-vaccination crying duration was recorded in all groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the multisensory stimulus method;
In the multisensory stimulus method;
Multisensory stimulus method not applied:
The baby was breastfed by its mother for 20 minutes. Breastfeeding was stopped just before the vaccination.
Time frame: Measured 5 minutes before, 2 minutes before, immediately before, immediately after, 2 minutes after and 5 minutes after vaccination in all groups
The FLACC pain scale score decreased, the oxygen saturation value measured by pulse oximetry was measured higher, the heart rate measured by pulse oximetry was measured lower, and the crying time measured by stopwatch was measured lower in the infants who underwent multisensory stimulus method compared to the control group.
Time frame: Measured 5 minutes before, 2 minutes before, immediately before, immediately after, 2 minutes after and 5 minutes after vaccination in all groups
The pain score measured with the FLACC pain scale was lower, the oxygen saturation value measured with pulse pulse oximetry was higher, there was no statistically significant difference between the heart rate values, and the crying time measured with a stopwatch was less in the group in which the mother applied multiple sensory stimuli during the vaccination procedure compared to the nurse group.
Istanbul University - Cerrahpasa
Other
The Effect of Multisensory Stimulus Method Used During Immunisation on Pain and Physiological Parameters in Infants: A Randomised Controlled Study
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