- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06266507
Undersøgelse af effekten af ergoterapi-baseret forældrecoaching på ernæringsproblemer hos børn med en for tidlig fødsel
Undersøgelse af effekten af ergoterapi-baseret forældrecoaching på ernæringsproblemer hos børn med en historie med for tidlig fødsel
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ankara/ Altındağ
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Ankara, Ankara/ Altındağ, Tyrkiet (Türkiye), 06110
- Ankara Medipol University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Barnets præmaturitet (fødselsuge <37)
- Barnet er mellem 3-6 år
- Moderen skal have kompetence til at bruge online platforme, teknologiske værktøjer og internetforbindelse.
- Moderen skal have tilstrækkelig uddannelse til at læse, forstå og udfylde skalaerne.
- Mødre indberetter klager over fodringsproblemer hos deres børn
Ekskluderingskriterier:
- Det kan påvirke barnets fodring; At have en fødevareallergi, handicap, neuroudviklingssygdom, kromosomale eller strukturelle anomalier
- Barnet ernæres ikke oralt
- At være i ergoterapi, oral motorisk terapi eller ernæringsterapi på ethvert center
- Ikke at tillade praksis såsom videodeling, kamera/lyddeling og optagelse af sessioner under interventionen.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Forskningsgruppe
Mødre, der vil modtage en 10 ugers ergoterapibaseret forældrecoachingintervention, vil blive inkluderet i denne gruppe.
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Ergoterapibaseret forældrecoachingintervention vil vare 10 sessioner og vil blive udført på online platformen.
Sessioner er planlagt til at vare mellem 45-60 minutter.
De samtaler, der skal afholdes under sessionerne, betragtes som de grundlæggende principper for forældrecoaching; Det vil blive gennemført i overensstemmelse med principperne om fælles planlægning, observation, implementering, refleksion og feedback.
Denne intervention har til formål at oplyse mødre om korrekte ernæringsstrategier for deres børn og at sætte dem i stand til at udføre disse praksisser uafhængigt.
Andre navne:
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Andet: Kontrolgruppe
Kontrollen vil ikke modtage en aktiv intervention, men vil blive forsynet med en informativ brochure om tidlig barndomsudvikling.
Desuden vil retten til at deltage i interventionen blive givet, når forskningen er afsluttet.
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Der vil ikke blive foretaget nogen aktiv intervention over for mødrene i målgruppen; en informativ brochure om tidlig barndomsudvikling vil blive distribueret.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Behavioral Pediatric Feeding Assessment Scale
Tidsramme: The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
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This scale will be used to evaluate children's nutritional problems.
Behavioral Pediatrics Feeding Assessment Scale (BPFAS) was developed by Crist and Napier Philips in 2001 and its original version consists of 35 questions.
The usage age range of the survey is between 9 months and 7 years, and it is the scale with the most comprehensive reliability and validity data among the nutrition surveys administered by parents for preschool children.
The questionnaire has good test-retest reliability and internal consistency, acceptable-to-good sensitivity, and good-to-excellent specificity.
The BPFAS is capable of screening for a broad spectrum of feeding difficulties (nutritional and textural selectivity, food refusal, and oral motor difficulties).
Turkish validity study by Önal et al.
It was made by in 2017.
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The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
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Sensory Profile Questionnaire - Oral Sensory Processing Test
Tidsramme: The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
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This scale will be used to examine how children's oral sensory processing skills change before and after the intervention. Ergotherapist Prof. Sensory Profile of the individual developed by Winnie Dunn; It is a measurement tool used to evaluate sensory modulation, in other words, the tendency to respond to sensory stimuli during daily activities and which sensory systems affect daily life more. It is used in children between the ages of 3-10. The individual; The test, which is used to measure functional performance in daily living activities, sensory processing abilities and sensory processing effects, consists of 3 main sub-parameters (sensory processing, modulation and behavioral-emotional responses) and 9 factor scores consisting of these parameters. *In our study, it was decided to use only the oral sensory processing subtest of questionnaire. |
The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
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Canadian Occupational Therapy Measurement (COPM)
Tidsramme: The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
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The Canadian Occupational Performance Measurement (COPM) is an outcome measure designed to identify changes in individuals' perceived performance and satisfaction levels over time in the areas of self-care, productivity, and leisure.
In the application of the COPM, the client is first interviewed and listed occupations they want to do, are expected to do, but are unable to do, or are dissatisfied with the way they are performed.
Performance and satisfaction levels are recorded before and after the intervention, allowing the difference between the two assessments to be calculated.
The COPM will be used in this study to determine participants' goals for the intervention and to examine changes in performance and satisfaction following the intervention for the identified occupations.
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The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
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Feeding Strategies Quesstionnaire
Tidsramme: The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
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This questionnaire will be used to measure whether mothers' feeding strategies have changed before and after the intervention.It is a scale developed by Berlin et al. in 2005 to measure parents' feeding strategies for their children.
FSQ consists of 27 items and is administered to children between the ages of 2-6.
FSQ; It consists of 6 subheadings: child control in eating, meal time, environment structure, family control in eating, release and coercive interventions.
The FSQ scale includes answers ranging from 1 (strongly disagree) to 5 (strongly agree).
It has been reported that the Feeding Strategies Scale can be used to evaluate child and parent feeding strategies regarding the prevention or treatment of pediatric feeding difficulties.
A Turkish adaptation study was carried out by Meral in 2017, and the total Cronbach alpha value of the scale is 0.80.
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The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
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Parental Self-Efficacy Scale
Tidsramme: The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
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This scale will be used to examine how parents' self-efficacy changes before and after parent coaching intervention.
Parental Self-Efficacy Scale Guimond et al.
It was developed by Cavkaytar et al. in 2005 and adapted into Turkish by Diken in 2007.
It is a scale updated in 2014 and used to measure the self-efficacy perceptions of parents of children with disabilities regarding their parenting skills.
The scale is a 7-point Likert-type rating scale and consists of a total of 17 items.
The lowest score can be obtained from the scale, 17 points, and the highest score can be 119 points.
As the score obtained from the scale increases, the level of self-efficacy also increases.
Cronbach's Alpha internal consistency coefficient of the scale was found to be 0.95.
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The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Numerical Rating Scale
Tidsramme: This assessment was planned to be applied to the intervention group in post-intervention (T1: week 10) and post-follow-up (T2: week 14) evaluations.
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In this study, satisfaction was assessed in parents in the intervention group during post-intervention (T1) and follow-up (T2) evaluations.
A single-item 0-10 (0=not satisfied at all, 10=very satisfied) numerical rating scale was used to assess overall satisfaction with Occupational Therapy Based Parent Coaching.
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This assessment was planned to be applied to the intervention group in post-intervention (T1: week 10) and post-follow-up (T2: week 14) evaluations.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Gökçen Akyürek, Ph. D., Hacettepe University
Publikationer og nyttige links
Generelle publikationer
- Walton K, Daniel AI, Mahood Q, Vaz S, Law N, Unger SL, O'Connor DL. Eating Behaviors, Caregiver Feeding Interactions, and Dietary Patterns of Children Born Preterm: A Systematic Review and Meta-Analysis. Adv Nutr. 2022 Jun 1;13(3):875-912. doi: 10.1093/advances/nmac017.
- Dev DA, Padasas I, Hillburn C, Stage VC, Dzewaltowski DA. Ecological Approach to Family-Style, Multilevel Child Care Intervention: Formative Evaluation Using RE-AIM Framework. J Nutr Educ Behav. 2022 Aug;54(8):728-744. doi: 10.1016/j.jneb.2022.03.005. Epub 2022 Jun 26.
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
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Psykiske lidelser
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Tegn og symptomer, fordøjelsessystemet
- Obstetrisk arbejde, for tidligt
- Obstetriske arbejdskomplikationer
- Graviditetskomplikationer
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Tegn og symptomer
- Adfærd, dyr
- For tidlig fødsel
- Ernærings- og spiseforstyrrelser
- Fodringsadfærd
Andre undersøgelses-id-numre
- 169
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