Soft Tissue Therapy in Managing Procedural Pain Among Neonates.

NCT04309162 | Completed DMC

• 2 other identifiers: MMDU/IEC/1528U1111-1249-2317
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neonatal Disorder

Keywords

Neonatal; Newborns; Infant; NICU; Procedural Pain; Massage Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Neonatal Infant Pain Scale (NIPS)

  Neonatal Infant Pain Scale is basically a behavioral tool and can be used in preterm and full term infants. The total score is 7. NIPS score is divided into 3 categories. 0-2 indicates no pain, 3-4 mild to moderate pain, \>4 indicates severe pain.

  Baseline, 4 days after the intervention.

Secondary Outcomes (1)

• Change in Neonatal Pain Agitation and sedation scale(N-PASS)

  Baseline, 4 days after the intervention

Study Arms (1)

soft tissue therapy

EXPERIMENTAL

Soft tissue therapy includes various techniques which is usually done by manipulating the soft tissues. The techques like stroking, petrissage, percussing maniulations are proved helpful in managing various painful conditions. The main effect of the soft tissue therapy is enhanced blood circulation to the area. When the techniques of soft tissue therapy are applied they will results in stretching and rubbing the muscular tissue which results in increased venous flow to heart and removal of the lactic acid accumulation occurs as the fresh supply of blood to the area will increased. Endorphins the natural pain relievers are released as there is improved oxygenation and perfusion of oxygen in tissues.

Other: Soft tissue therapy

Interventions

Soft tissue therapy OTHER

Soft tissue therapy consists of various soft tissue manipulating techniques which includes the stroking, percussive and tapping manipulations. The treatment techniques are divided according to the body parts. under this techniques are tapping, flat finger kneading, Stroking, skin rolling etc.

soft tissue therapy

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Neonates who underwent various painful procedures in NICU such as venous, arterial and capillary puncture, mechanical ventilation for pulmonary causes, tracheal intubation, adhesive tapes removal, insertion of various drains etc.
• Preterm, Term, Post terms Neonates
• Stable Neonates.

You may not qualify if:

• Post-Surgical cases
• Parents of Neonates who are not willing to enroll their infant in study.
• Neonates with congenital anomalies.
• Neonates with extreme low birth weight.

Sponsors & Collaborators

• Asir John Samuel: lead

Study Sites (1)

Abhishek Sharma

Ambāla, Haryana, 133207, India

Location

Related Publications (4)

• Brummelte S, Grunau RE, Chau V, Poskitt KJ, Brant R, Vinall J, Gover A, Synnes AR, Miller SP. Procedural pain and brain development in premature newborns. Ann Neurol. 2012 Mar;71(3):385-96. doi: 10.1002/ana.22267. Epub 2012 Feb 28.

  PMID: 22374882 RESULT

• Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4):21. doi: 10.3390/children4040021.

  PMID: 28368368 RESULT

• Field T, Diego M, Hernandez-Reif M. Preterm infant massage therapy research: a review. Infant Behav Dev. 2010 Apr;33(2):115-24. doi: 10.1016/j.infbeh.2009.12.004.

  PMID: 20137814 RESULT

• Jain S, Kumar P, McMillan DD. Prior leg massage decreases pain responses to heel stick in preterm babies. J Paediatr Child Health. 2006 Sep;42(9):505-8. doi: 10.1111/j.1440-1754.2006.00912.x.

  PMID: 16925535 RESULT

Related Links

• Preterm infants are exposed to various painful procedures in Neonatal intensive care unit. Early Procedural pain exposure results int the harmful effects on the development of brain.
• randomized controlled trials on the effects of massage in preterm infants suggest improved weight gain and shortened length of hospital stay. Improved weight gain may be mediated through increase in vagal tone but more studies are needed.
• Massage therapy is considered as the effective non pharmacological measure for reducing the procedural pain in NICU and reduces their hospital stay.
• By applying massage therapy before doing heel stick procedure pain responses are reduced in preterm infants

MeSH Terms

Conditions

Infant, Newborn, Diseases; Pain, Procedural

Interventions

Therapy, Soft Tissue

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Abhishek Sharma, BPT

  Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Asir J Samuel, MPT, PhD

  Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation

  STUDY CHAIR

• Neha Sharma, MPT

  Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The neonates admitted in NICU are masked.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Maharishi Markandeshwar (Deemed to be university)

Model Details: A single group Pretest-Posttest quasi experimental design

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 16, 2020
• Study Start: August 3, 2020
• Primary Completion: February 26, 2021
• Study Completion: March 31, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)