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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Haryana
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Ambala, Haryana, Indië, 133207
- Abhishek Sharma
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Neonatal Infant Pain Scale (NIPS)
Tijdsspanne: Baseline, 4 days after the intervention.
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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.
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Baseline, 4 days after the intervention.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Neonatal Pain Agitation and sedation scale(N-PASS)
Tijdsspanne: Baseline, 4 days after the intervention
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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.
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Baseline, 4 days after the intervention
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Abhishek Sharma, BPT, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Publicaties en nuttige links
Algemene publicaties
- 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.
Nuttige 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
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MMDU/IEC/1528
- U1111-1249-2317 (Andere identificatie: Universal Trial Number (UTN) by WHO ICTRP)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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