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

NCT06845137 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SEC/SAHS/PHD/24/09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Disorder

Keywords

Neonates, Cortisol, Massage, Tactile Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in the cortisol level

  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

  4 days after intervention

Secondary Outcomes (1)

• Change in Neonatal Infant Pain Scale (NIPS)

  4 days after intervention

Study Arms (2)

Experimental Group

EXPERIMENTAL

In this study, preterm neonates in the experimental group received TKS and STM as part of their intervention. TKS involved the passive range of motion exercises for the neonates' joints, aiming to enhance mobility and stimulate neuromuscular responses. STM, on the other hand, incorporated various techniques such as gentle stroking, petrissage, and percussion, all of which were designed to improve circulation and facilitate pain management. Stroking techniques provided a soothing effect, while petrissage-through kneading and compression-helped in muscle relaxation and circulation enhancement. Percussion techniques further contributed to muscle stimulation and fluid movement, ultimately supporting physiological stability. These interventions promoted venous return to the heart, cleared lactic acid buildup, and facilitated increased oxygen delivery to tissues. The improved blood flow also triggered endorphin release, serving as a natural pain reliever, thereby reducing discomfort and enh

Other: Tactile-Kinesthetic Stimulation (TKS) and Soft Tissue Manipulation (STM)

Standard Treatment

ACTIVE COMPARATOR

The Neonate will receive all the nursing care plan as described in experimental except tactile and massage from the therapist.

Other: Standard Therapy

Interventions

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

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,

Experimental Group

Standard Therapy OTHER

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

Standard Treatment

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Post-Surgical/operative cases
• Infants with neurological conditions such as siezures etc.
• Neonates/infants with congenital anomalies.
• Neonates with extremely low birth weight

Sponsors & Collaborators

• faizan kashoo, PT: lead
• Galgotias University: collaborator

Study Sites (1)

Hospital

Roorkee, Uttarakhand, 247661, India

Location

MeSH Terms

Conditions

Infant, Newborn, Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Abhishek Chahal Sharma, MPT

CONTACT

+917404606942; abhishek.23smas3030003@galgotiasuniversity.edu.in

Aksh Professor, PhD

CONTACT

+919711774174; aksh.chahal@galgotiauniversity.edu.in

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: March 20, 2025
• Primary Completion: October 15, 2025
• Study Completion: December 31, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

IN (1)