Soft Tissue Therapy in Managing Procedural Pain Among Neonates.

Neonatal Disorder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309162
• Other study ID #: MMDU/IEC/1528
• Secondary ID: U1111-1249-2317
• Status: Completed
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 31, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Neonatal Disorder
• Pain, Procedural

Intervention

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.

Locations

Country	Name	City	State
India	Abhishek Sharma	Ambala	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Asir John Samuel

Country where clinical trial is conducted

India, 

References & Publications (4)

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. — View 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. Review. — View 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. — View Citation

Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4). pii: E21. doi: 10.3390/children4040021. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   By applying massage therapy before doing heel stick procedure pain responses are reduced in preterm infants
•   Massage therapy is considered as the effective non pharmacological measure for reducing the procedural pain in NICU and reduces their hospital stay.
•   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.