Impact of Tactile Kinesthetic Stimulation and Soft Tissue Manipulation on Cortisol in Preterm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tactile-Kinesthetic Stimulation (TKS) and Soft Tissue Manipulation (STM), Standard Therapy.
- Who it may be relevant to
- Registry conditions: Neonatal Disorder. Basic parameters: 0 Days — 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Tactile-Kinesthetic Stimulation and Soft Tissue Manipulation on Blood Cortisol Levels in Preterm Neonates Admitted to Pediatric Care Settings: a Prospective Experimental Study
Overview
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.
Detailed description
Preterm neonates are highly vulnerable to stress due to their immature physiological systems and exposure to intensive medical treatments. Elevated blood cortisol levels, a key indicator of stress, have been linked to negative neurodevelopmental and physiological outcomes. Tactile-Kinesthetic Stimulation (TKS) and Soft Tissue Manipulation (STM) are non-invasive therapeutic approaches that may help alleviate stress and support overall development in preterm infants. TKS and STM were chosen for their proven benefits in promoting neurodevelopment, stress reduction, and physiological stability in preterm neonates. Unlike pharmacological interventions, these non-invasive therapies enhance blood circulation, regulate cortisol levels, and improve autonomic function, fostering growth and early adaptation to extrauterine life without adverse effects. This prospective experimental study aims to assess the impact of TKS and STM on blood cortisol levels and pain in preterm neonates admitted to pediatric care units. The intervention group will receive TKS and STM. TKS includes passive range of motion for upper and lower limbs whereas STM includes effleurage/stroking, petrissage, frictional and percussive manipulations daily for 24 minutes over four consecutive days, while the control group will receive standard neonatal care without additional interventions. Blood samples for cortisol measurement will be collected on days 1 and 4. Secondary outcomes will include physiological parameters such as heart rate, oxygen saturation, and weight gain. Statistical analyses will compare baseline and post-intervention cortisol levels within and between groups. Trained staff nurse will measure blood cortisol using ELISA. Participants, statisticians, and outcome assessors remain blinded. ELISA ensures high reliability (intra-assay CV \<10%) and validity (correlates strongly with gold-standard mass spectrometry). Blood cortisol levels in preterm neonates can be influenced by factors like gestational age, birth weight, medical interventions, pain, stress, feeding patterns, and NICU environment. To control variability, standardized stimulation protocols, consistent feeding schedules, minimal handling outside interventions and controlled ambient conditions (light, noise, temperature) were maintained, ensuring that observed cortisol changes were primarily due to the intervention We anticipate that preterm neonates receiving TKS and STM will exhibit a significant reduction in blood cortisol levels and pain compared to those in the control group, along with improvements in secondary outcomes. This study aims to generate evidence supporting the efficacy of TKS and STM in reducing stress biomarkers, ultimately promoting their integration into neonatal care protocols to enhance the developmental outcomes of preterm infants
Interventions
- Other 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 - Other 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 provi
Primary outcome measures
- Change in the cortisol level [Time frame: 4 days after intervention]
Secondary outcome measures (1)
- Change in Neonatal Infant Pain Scale (NIPS) [Time frame: 4 days after intervention]
Eligibility criteria
Inclusion criteria
- Underwent medical procedures associated with procedural pain, such as venipuncture, heel pricks, or tracheal intubation.
- Preterm neonates (28 to 36 weeks of gestation)
- Stable Neonates
Exclusion criteria
- Post-Surgical/operative cases
- Infants with neurological conditions such as siezures etc.
- Neonates/infants with congenital anomalies.
- Neonates with extremely low birth weight
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
India · 1 center
- Hospital — Roorkee
Identifiers
NCT: NCT06845137 · SEC/SAHS/PHD/24/09