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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04309162
Enrollment
7
Registered
2020-03-16
Start date
2020-08-03
Completion date
2021-03-31
Last updated
2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Disorder

Keywords

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

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.

Interventions

OTHERSoft 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.

Sponsors

Asir John Samuel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

The neonates admitted in NICU are masked.

Intervention model description

A single group Pretest-Posttest quasi experimental design

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Neonatal Infant Pain Scale (NIPS)Baseline, 4 days after the intervention.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

MeasureTime frameDescription
Change in Neonatal Pain Agitation and sedation scale(N-PASS)Baseline, 4 days after the interventionN-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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026