Soft Tissue Therapy in Managing Procedural Pain Among Neonates.

NCT ID: NCT04309162

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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Background: Neonatal intensive care unit (NICU) is a specialized unit created for sick and premature newborns. There are various painful procedures through which neonates have to undergo during the NICU stay. The most common procedure is the blood tests for the laboratory investigations which include the heel lancing and venipuncture. Pain is the one of the cause of the development of the acute stress in neonates soft tissue therapy has considered as the major contributory factor of in reducing the procedural pain among neonates admitted NICU. There is no documentation on soft tissue therapy in managing procedural pain in neonates.

Purpose: To determine the effects of soft tissue therapy in managing procedural pain among neonates admitted in NICU.

Methods and materials: The study will recruit neonates who underwent for various painful procedures in NICU such as venous and arterial puncture, capillary puncture, pulmonary mechanical ventilation, tracheal intubation, removal of adhesive tapes, the introduction of various drains etc. Preterm, Term, Full terms Neonates Stable Neonates. The samples will be taken via stratified random sampling technique. Neonates with unstable vitals are to be excluded from the study.

Discussion: To best of our knowledge, this will be the first study determining the effects of soft tissue therapy in procedural pain on neonates admitted in NICU. The role of neonatal physiotherapist in NICU is to provide diagnosis and treatment to admitted newborns. Massage therapy is considered as an effective management technique in pain management. In this study soft tissue therapy will be applied to neonates especially in context with procedural pain. There are various painful procedures performed to check the prognosis of neonates.

Keywords: Neonatal; Newborns; Infant; NICU; Procedural pain; Massage therapy.

Conditions

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Neonatal Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A single group Pretest-Posttest quasi experimental design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The neonates admitted in NICU are masked.

Study Groups

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soft tissue therapy

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.

Group Type EXPERIMENTAL

Soft tissue therapy

Intervention Type 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.

Interventions

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Soft tissue therapy

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Preterm, Term, Post terms Neonates
3. Stable Neonates.

Exclusion Criteria

1. Post-Surgical cases
2. Parents of Neonates who are not willing to enroll their infant in study.
3. Neonates with congenital anomalies.
4. Neonates with extreme low birth weight.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Asir John Samuel

OTHER

Sponsor Role lead

Responsible Party

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Asir John Samuel

Associate Professor Maharishi Markandeshwar (Deemed to be university)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Abhishek Sharma, BPT

Role: PRINCIPAL_INVESTIGATOR

Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation

Asir J Samuel, MPT, PhD

Role: STUDY_CHAIR

Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation

Neha Sharma, MPT

Role: STUDY_DIRECTOR

Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation

Locations

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Abhishek Sharma

Ambāla, Haryana, India

Site Status

Countries

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India

References

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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.

Reference Type RESULT
PMID: 22374882 (View on PubMed)

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

Reference Type RESULT
PMID: 28368368 (View on PubMed)

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.

Reference Type RESULT
PMID: 20137814 (View on PubMed)

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.

Reference Type RESULT
PMID: 16925535 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3760843/

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.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2844909/

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.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5406680/

Massage therapy is considered as the effective non pharmacological measure for reducing the procedural pain in NICU and reduces their hospital stay.

https://www.ncbi.nlm.nih.gov/pubmed/16925535/

By applying massage therapy before doing heel stick procedure pain responses are reduced in preterm infants

Other Identifiers

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U1111-1249-2317

Identifier Type: OTHER

Identifier Source: secondary_id

MMDU/IEC/1528

Identifier Type: -

Identifier Source: org_study_id

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