Clinical trial NCT04309162: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Disorder
Keywords: Neonatal
Newborns
Infant
NICU
Procedural Pain
Massage Therapy
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group Pretest-Posttest quasi experimental design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Neonatal Infant Pain Scale (NIPS)
timeFrame: Baseline, 4 days after the intervention.
Secondary outcomes:
measure: Change in Neonatal Pain Agitation and sedation scale(N-PASS)
timeFrame: Baseline, 4 days after the intervention
Other outcomes:
Locations:
city: Ambala
country: India
facility: Abhishek Sharma
state: Haryana
Study officials:
affiliation: Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
name: Abhishek Sharma, BPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
name: Asir J Samuel, MPT, PhD
role: STUDY_CHAIR
affiliation: Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
name: Neha Sharma, MPT
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.