search
Back to results

Soft Tissue Therapy in Managing Procedural Pain Among Neonates.

Primary Purpose

Neonatal Disorder

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Soft tissue therapy
Sponsored by
Asir John Samuel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Disorder focused on measuring Neonatal, Newborns, Infant, NICU, Procedural Pain, Massage Therapy

Eligibility Criteria

1 Day - 28 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Abhishek Sharma

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

soft tissue therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Neonatal Pain Agitation and sedation scale(N-PASS)
N-PASS is scale which is used to assess Procedural, postoperative mechanically . ventilated patients. It includes variables like crying, irritability, facial expression, extremity tone and vital signs. It is 0 to 10 scale high level of score indicates more aggression and intense behavior and low levels indicates decreased level of stimulation and deeper sedation.

Full Information

First Posted
March 6, 2020
Last Updated
April 12, 2021
Sponsor
Asir John Samuel
search

1. Study Identification

Unique Protocol Identification Number
NCT04309162
Brief Title
Soft Tissue Therapy in Managing Procedural Pain Among Neonates.
Official Title
Soft Tissue Therapy in Managing Procedural Pain Among Neonates Admitted in Neonatal Intensive Care Unit: A Single Group, Pretest Posttest Quasi Experimental Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asir John Samuel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Disorder
Keywords
Neonatal, Newborns, Infant, NICU, Procedural Pain, Massage Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single group Pretest-Posttest quasi experimental design
Masking
None (Open Label)
Masking Description
The neonates admitted in NICU are masked.
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
soft tissue therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Soft tissue therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Neonatal Infant Pain Scale (NIPS)
Description
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.
Time Frame
Baseline, 4 days after the intervention.
Secondary Outcome Measure Information:
Title
Change in Neonatal Pain Agitation and sedation scale(N-PASS)
Description
N-PASS is scale which is used to assess Procedural, postoperative mechanically . ventilated patients. It includes variables like crying, irritability, facial expression, extremity tone and vital signs. It is 0 to 10 scale high level of score indicates more aggression and intense behavior and low levels indicates decreased level of stimulation and deeper sedation.
Time Frame
Baseline, 4 days after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhishek Sharma, BPT
Organizational Affiliation
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asir J Samuel, MPT, PhD
Organizational Affiliation
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Neha Sharma, MPT
Organizational Affiliation
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Abhishek Sharma
City
Ambala
State/Province
Haryana
ZIP/Postal Code
133207
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22374882
Citation
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.
Results Reference
result
PubMed Identifier
28368368
Citation
Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4):21. doi: 10.3390/children4040021.
Results Reference
result
PubMed Identifier
20137814
Citation
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.
Results Reference
result
PubMed Identifier
16925535
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3760843/
Description
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.
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2844909/
Description
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.
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5406680/
Description
Massage therapy is considered as the effective non pharmacological measure for reducing the procedural pain in NICU and reduces their hospital stay.
URL
https://www.ncbi.nlm.nih.gov/pubmed/16925535/
Description
By applying massage therapy before doing heel stick procedure pain responses are reduced in preterm infants

Learn more about this trial

Soft Tissue Therapy in Managing Procedural Pain Among Neonates.

We'll reach out to this number within 24 hrs