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

February 20, 2025 updated by: faizan kashoo, PT

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
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)

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,
Active Comparator: Standard Treatment
The Neonate will receive all the nursing care plan as described in experimental except tactile and massage from the therapist.
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 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the cortisol level
Time Frame: 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
4 days after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Neonatal Infant Pain Scale (NIPS)
Time Frame: 4 days after intervention
The Neonatal Infant Pain Scale (NIPS) is a behavioral assessment tool applicable to both preterm and full-term infants. It has a total score of 7, categorized as follows: 0-2 signifies no pain, 3-4 indicates mild to moderate pain, and a score above 4 suggests severe pain.
4 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
faizan kashoo, PT

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Galgotias University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SEC/SAHS/PHD/24/09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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