Soft Tissue Therapy in Managing Procedural Pain Among Neonates.

Soft Tissue Therapy in Managing Procedural Pain Among Neonates Admitted in Neonatal Intensive Care Unit: A Single Group, Pretest Posttest Quasi Experimental Study.

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Disorder
• Intervention / Treatment: Other: Soft tissue therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Ambala, Haryana, India, 133207
      • Abhishek Sharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 4 days after the intervention

Collaborators and Investigators

• Sponsor: Asir John Samuel
• Investigators: Principal Investigator: Abhishek Sharma, BPT, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

Publications and helpful links

General Publications

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

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): February 26, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Infant; Newborns; NICU; Neonatal; Massage Therapy; Procedural Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural; Infant, Newborn, Diseases
• Other Study ID Numbers: MMDU/IEC/1528; U1111-1249-2317 (Other Identifier: Universal Trial Number (UTN) by WHO ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No