Prospective Experimental Study Protocol: Evaluating the Impact of Tactile-Kinesthetic Stimulation and Soft Tissue Manipulation on Blood Cortisol Levels in Preterm Neonates Admitted to Pediatric Care Settings (TACTICS Trial)

Abstract

Background: Preterm neonates are highly susceptible to stress following their underdeveloped physiological systems and exposure to intensive medical interventions. Elevated blood cortisol levels and indicative of stress have been associated with adverse neurodevelopmental and physiological outcomes. Tactile-Kinesthetic Stimulation (TKS) and Soft Tissue Manipulation (STM) are non-invasive therapeutic interventions that may mitigate stress and promote overall development preterm neonates. This prospective experimental study aims to investigate effects of TKS and STM on blood cortisol levels in preterm neonates admitted to pediatric care settings. Methods: A total of 232 preterm neonates between 28 and 36 weeks of gestation will be randomly allocated into Intervention and Control group. The intervention group will receive TKS and STM twice daily for 24 minutes over 4 consecutive days, while the control group will receive standard care without additional interventions. Blood samples for cortisol levels will be collected on day 1 and day 4. Secondary outcomes comprise of physiological parameters (heart rate, oxygen saturation) and weight gain. Statistical analysis will compare baseline and post-intervention cortisol levels within and between groups. Expected Outcomes: We hypothesize that preterm neonates receiving TKS and STM to show significant reductions in blood cortisol levels and pain compared to the control group, alongside improved secondary outcomes. Conclusion: This study will provide evidence on the effectiveness of TKS and STM in reducing stress biomarkers, paving the way for integrating these interventions into neonatal care protocols to enhance the developmental trajectory of preterm infants.