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临床试验/NCT06291519
NCT06291519已完成不适用

The Effect of Multisensory Stimulus Method Used During Immunisation on Pain and Physiological Parameters in Infants: A Randomised Controlled Study

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 96 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
2
主要终点
The Effect of Multiple Sensory Stimulus Method

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
2 Months 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Being healthy
  • Parental consent to participate in the study
  • Born between 38-42 weeks of gestation
  • To take part in the routine vaccination programme of the Ministry of Health

排除标准

  • - Having taken analgesic, muscle relaxant or sedation within the last 4 hours

研究组 & 干预措施

Experimental Group 3

Experimental

In this group, the mother breastfed her baby for 20 minutes before vaccination. Breastfeeding was terminated before vaccination. FLACC pain scale, SPO2, and pulse oximetry were evaluated and recorded 5 min before and 2 min after vaccination, immediately before vaccination, immediately after vaccination (pain during the procedure), and 2 and 5 min after the procedure.

干预措施: Breastfeeding Applied Group (Other)

Control Group

No Intervention

Babies in this group did not receive any treatment. A light touch was applied for ethical reasons. FLACC pain scale, SPO2, and pulse oximetry were evaluated and recorded 5 min before and 2 min after vaccination, immediately before vaccination, immediately after vaccination (pain during the procedure), and 2 and 5 min after the procedure.

Experimental Group 1

Experimental

In this group, the mother applied multiple sensory stimuli. In this group, the mothers of the babies to be vaccinated applied multiple sensory stimuli such as breastfeeding, mother's voice, touch-light massage, and eye contact. The mother breastfed her baby for a total of 20 minutes. Breastfeeding was terminated before vaccination. Other applications were applied for 5 minutes before vaccination and 5 minutes after vaccination. FLACC pain scale, SPO2, and pulse oximetry were evaluated and recorded 5 min before and 2 min after vaccination, immediately before vaccination, immediately after vaccination (pain during the procedure), and 2 and 5 min after the procedure.

干预措施: Multi-sensory Stimulation Method-Mother Applying the Method to the Baby (Other)

Experimental Group 2

Experimental

In this group, the nurse applied multiple sensory stimuli. In this group, the mothers of the babies to be vaccinated breastfed the baby for 20 minutes. The mother stopped breastfeeding before the vaccination procedure. The nurse started to give multisensory stimuli. The nurse administered multisensory stimuli including soft tone of voice, touch-light massage, and eye contact 5 minutes before the vaccination. Other applications were applied 5 minutes before and 5 minutes after vaccination. FLACC pain scale, SPO2, and pulse oximetry were evaluated and recorded 5 min before and 2 min after vaccination, immediately before vaccination, immediately after vaccination (pain during the procedure), and 2 and 5 min after the procedure.

干预措施: Multi-sensory Stimulation Method-Nurse Applying the Method to the Baby (Other)

结局指标

主要结局

The Effect of Multiple Sensory Stimulus Method

时间窗: 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.

次要结局

  • Comparison of the group in which the mother applied multiple sensory stimuli and the group in which the nurse applied multiple sensory stimuli(Measured 5 minutes before, 2 minutes before, immediately before, immediately after, 2 minutes after and 5 minutes after vaccination in all groups)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kadriye Sahin

Research Assistant -( RN, MSc, PhDc)

Istanbul University - Cerrahpasa

研究点 (2)

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