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Starting soon Phase 1

Impact of Tactile Kinesthetic Stimulation and Soft Tissue Manipulation on Cortisol in Preterm

NCT06845137 · tracked via the Priya Life Science India tracker
Sponsor
faizan kashoo, PT
Phase
Phase 1
Started
2025-03-20
Last updated
2025-02-25

Condition(s) studied

Neonatal Disorder

Investigational drug(s) / intervention(s)

Tactile-Kinesthetic Stimulation (TKS) and Soft Tissue Manipulation (STM)Standard Therapy

Tactile-Kinesthetic Stimulation (TKS) and Soft Tissue Manipulation (STM): Tactile-Kinesthetic Stimulation (TKS): TKS involves the application of tactile (touch) and kinesthetic (movement) stimuli to various parts of the body. This technique aims to enhance sensory awareness and motor control. TKS can include gentle tapping, brushing, or vibration on the skin, joints, or muscles. The sensory input provided through TKS helps in proprioceptive feedback, which is essential for improving body awareness, coordination, and movement patterns. It is often used in neurological rehabilitation to facilitate neuromuscular re-education and in pediatric therapy to promote sensory integration. Soft Tissue Manipulation (STM): STM involves various manual techniques applied to the soft tissues of the body, including muscles, tendons, ligaments, and fascia. These techniques can range from gentle stretching and mobilization to deeper techniques such as myofascial release, trigger point therapy, and deep tissue massage. STM aims to alleviate muscle tension, improve flexibility,

Standard Therapy: Nursing care for preterm neonates involves a higher level of monitoring and specialized support due to their underdeveloped physiological systems. Nurses focus on maintaining thermal regulation through incubators or radiant warmers to prevent hypothermia, as preterm infants are more vulnerable to temperature instability. Respiratory support is critical, often requiring continuous positive airway pressure (CPAP) or mechanical ventilation to assist with immature lungs. Nutritional support is provided through intravenous fluids or gavage feeding (tube feeding) if the infant is not yet able to breastfeed or bottle-feed. Nurses also monitor for complications such as hypoglycemia, infection, and jaundice and administer antibiotics, vitamin K, and eye prophylaxis as needed. Developmentally supportive care is emphasized, including minimizing sensory overload and encouraging kangaroo care (skin-to-skin contact) to support bonding, promote growth, and help regulate the neonate's heart rate, temp

Study summary

Effect of Soft tissue Therapy in managing Procedural Pain among neonates admitted to the neonatal intensive care unit. This study focuses on procedural pain management with the help of Soft tissue manipulation, which includes various techniques like stroking and petrissage manipulations.

Eligibility

Sex
ALL
Min age
0 Days
Max age
28 Days
Healthy volunteers
Accepted
Inclusion Criteria: 1. Underwent medical procedures associated with procedural pain, such as venipuncture, heel pricks, or tracheal intubation. 2. Preterm neonates (28 to 36 weeks of gestation) 3. Stable Neonates Exclusion Criteria: 1. Post-Surgical/operative cases 2. Infants with neurological conditions such as siezures etc. 3. Neonates/infants with congenital anomalies. 4. Neonates with extremely low birth weight

Primary outcome measure(s)

  • Change in the cortisol level — 4 days after intervention
    In neonates, particularly preterm infants, blood cortisol levels are used to evaluate stress and adrenal function. High cortisol levels may indicate physiological stress, infection, or discomfort, whereas persistently low levels could suggest adrenal insufficiency or an immature stress response. \[Time Frame: Baseline, 4 days after the intervention. Cortisol measurements were taken after four days to capture the cumulative physiological response to TKS and STM while minimizing acute fluctuations. Measuring after each session could reflect transient stress responses, whereas assessing only at the end might overlook early adaptive changes. This timing balances short-term hormonal variations with meaningful longitudinal effects on neonatal stress regulation

Trial sites (1)

FacilityCityRegionStatus
Hospital Roorkee Uttarakhand
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06845137 on ClinicalTrials.gov ↗ ← All trials in India