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NCT06291519

The Effect of Multisensory Stimulus Method on Pain and Physiological Parameters in Infants

Completed NA Last updated 4 March 2024
What this trial tests

NA trial testing Multi-sensory Stimulation Method-Mother Applying the Method to the Baby in Multisensory Stimulation in 96 participants. Completed in 30 December 2023.

Timeline
1 January 2023
Primary endpoint
30 December 2023
30 December 2023

Quick facts

Lead sponsorIstanbul University - Cerrahpasa
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment96
Start date1 January 2023
Primary completion30 December 2023
Estimated completion30 December 2023
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Istanbul University - Cerrahpasa

Who can join

Adults 2 Months to 6 Months, any sex, with Multisensory Stimulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The effect of multi-sensory stimuli used during vaccination on pain and physiological parameters in infants: A randomized controlled trial.
    Şahin K, Yıldız S, Gür E. · · 2026 · PMID 41500000 · DOI 10.1016/j.pedn.2025.11.051

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