- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07660159
EFFECTS OF TWO PAİN MANAGEMENT EDUCATİON METHODS DURİNG HEEL PRİCK PROCEDURES ON MATERNAL ANXİETY AND NEONATAL PAİN
THE EFFECT OF TWO DİFFERENT PAİN MANAGEMENT EDUCATİON METHODS PROVİDED FOR HEEL PRİCK PROCEDURES ON MOTHERS' USE OF NONPHARMACOLOGİCAL METHODS, ANXİETY LEVELS, AND NEONATAL PAİN
The aim of this research is to evaluate the effects of two different methods of education (verbal instruction + written brochure and verbal instruction + AI-assisted video presentation) given to new mothers on neonatal pain management, their use of non-pharmacological methods, anxiety levels, and neonatal pain, and to examine the relationship between them.
Research Questions Do two different pain management education methods affect mothers' use of nonpharmacological methods? Do two different pain management education methods affect mothers' anxiety levels? Do two different pain management education methods affect neonatal pain during heel prick procedures? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of mothers' use of nonpharmacological methods? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of maternal anxiety levels? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of neonatal pain during heel prick procedures? Is there a relationship between mothers' use of nonpharmacological methods and their anxiety levels? Is there a relationship between mothers' use of nonpharmacological methods and neonatal pain levels?
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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İ̇zmi̇t
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Kocaeli, İ̇zmi̇t, Tyrkiet (Türkiye)
- Kocaeli University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Being 19 years of age or older Being a primiparous mother Voluntarily agreeing to participate in the study Not having a psychiatric diagnosis Having a healthy term newborn baby (born at 38-42 gestational weeks) Having a blood sample taken for the Guthrie screening test
Exclusion Criteria:
Lack of Turkish reading and comprehension skills in the participant Incomplete completion of the survey form Having a baby with a congenital anomaly Having received any analgesia before the procedure Refusal to have a blood sample taken for the Guthrie screening test History of the baby staying in intensive care
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Control Group
The mothers underwent the clinic's routine procedure.
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Eksperimentel: verbal and brochure-based education
Mothers were given training on non-pharmacological pain management through verbal and brochure education.
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Non-pharmacological pain management methods for newborns were explained to mothers verbally and through brochures during heel prick blood tests.
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Eksperimentel: verbal and AI-assisted video training
Mothers were given training in non-pharmacological pain management through verbal instruction and AI-assisted video training.
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Non-pharmacological pain management methods for newborns were explained to mothers through verbal and AI-supported video training during heel prick blood sampling.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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mothers' anxiety
Tidsramme: between 24 and 72 hours after birth
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Those scoring between 20 and 80 points indicate anxiety.
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between 24 and 72 hours after birth
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Newborn Pain Scale (NIPS)
Tidsramme: between 24 and 72 hours after birth
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The scale consists of six parameters: facial expression, crying, breathing, arm movements, leg movements, and sleep-wake status.
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between 24 and 72 hours after birth
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2024/256
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Spædbarn
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Michael HoelscherClinton Health Access Initiative Inc.; Instituto Nacional de Saúde (INS)... og andre samarbejdspartnereAfsluttetHIV, Neonatal HIV Early-Infant-Diagnose (EID), Point-of-Care Testing (PoC)Mozambique, Tanzania
Kliniske forsøg med verbal and brochure-based education
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Saglik Bilimleri UniversitesiAfsluttetAstma hos børnKalkun
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Rigshospitalet, DenmarkFrederiksberg University Hospital; Defactum, Central Denmark RegionAfsluttet
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Marmara UniversityIkke rekrutterer endnuBrystkræftbevidsthed og BSE hos synshandicappede kvinderKalkun
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Rigshospitalet, DenmarkRekrutteringAkut myeloid leukæmi (AML)Danmark
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University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Afsluttet
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Massachusetts General HospitalMassachusetts Department of HealthAfsluttetStofbrug | Sundhedsrisikoadfærd | Teenagers adfærd | UngdomForenede Stater
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March of Dimes, CanadaHamilton Health Sciences CorporationAfsluttet
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Marmara UniversityAfsluttet
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University of OxfordBeijing Normal University; Beijing Stars and Rain Education Institute for...AfsluttetBørnemishandling | Forældre-barn relationer | Autismespektrumforstyrrelse | Forældreskab | Børns adfærdsproblem | Familieforhold | Psykisk sundhedsproblemKina