Clinical trial NCT06845137: Impact of Tactile Kinesthetic Stimulation and Soft Tissue Manipulation on Cortisol in Preterm
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Neonatal Disorder
Keywords: Neonates, Cortisol, Massage, Tactile Stimulation
Lead sponsor: Majmaah University
Sponsor class: OTHER
Collaborators: name: Galgotias University
First posted: 2025-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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 outcomes:
measure: Change in the cortisol level
timeFrame: 4 days after intervention
Secondary outcomes:
measure: Change in Neonatal Infant Pain Scale (NIPS)
timeFrame: 4 days after intervention
Other outcomes:
Locations:
city: Roorkee
country: India
facility: Hospital
state: Uttarakhand
Study officials:
References: