Phenylketonurias Clinical Trial
Official title:
The Effect of Nursing Empowerment Program Applied to Families of PKU Children, Coping Attitudes of Families and Phenylalanine Levels of Children
Verified date | October 2023 |
Source | Cukurova University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study has shown that the strengthening program applied to the families of children diagnosed with phenylketonuria (PKU) and the education given; It will be conducted in order to examine the effect of the family's coping attitudes, knowledge scores about the disease and its management. The research is of the randomized controlled experimental type. Children from PKU constitute the universe in the city center of Van. The families of children between the ages of 0-3 who were diagnosed with PKU will form the sample of the study. A nursing strengthening program will be applied to families in the experimental group for 10 weeks. The scope of this program; It consists of face-to-face training on disease management, giving the educational guide (booklet) for the families of babies diagnosed with PKU, telephone calls during the education process and counseling services. No application will be made to the families in the control group. After the application of the last tests to the control group; Face-to-face training and a booklet will be given to the experimental group. Data; It will be collected with 'Child and Family Introductory Information Form', 'Parents' Information Level Assessment Form about Phenylketonuria' and 'Coping Attitudes Assessment Scale'. In the literature, there is no study showing the effect of the education given to the families of babies diagnosed with PKU on their coping attitudes. Based on the need to fill this knowledge gap in the literature, it is thought that the study will contribute to the field of child health and disease nursing.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 22, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Day to 3 Years |
Eligibility | Inclusion Criteria: - Residing in Van and/or being followed up in the pediatric metabolism polyclinic, - Agreeing to participate in the research, - literate, - Speaking and understanding Turkish, - 18 years old and over - Fully oriented and cooperative and open to communication, - a parent who is the primary caregiver of the child, - The child is in the 0-3 age range (=3 years old), - Families of children with definitive diagnosis of PKU will be included. Exclusion Criteria: - Not residing in Van and/or not being followed up in the pediatric metabolism polyclinic, - Those who do not accept to participate in the research, who are illiterate, - Does not speak or understand Turkish, - Parent/family member who is aged 17 or younger, who is not fully oriented and cooperative and not open to communication, and does not provide primary care for the child, - The child is over 3 years old (3 years <), - Dropping out of the training to be applied, - Families of children with PKU who are not definitively diagnosed will not be included in the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Van Yuzuncu Yil University | Van | Tusba |
Lead Sponsor | Collaborator |
---|---|
Cukurova University |
Turkey,
MacDonald A, Depondt E, Evans S, Daly A, Hendriksz C, Chakrapani A A, Saudubray JM. Breast feeding in IMD. J Inherit Metab Dis. 2006 Apr-Jun;29(2-3):299-303. doi: 10.1007/s10545-006-0332-x. — View Citation
Pinto A, Adams S, Ahring K, Allen H, Almeida MF, Garcia-Arenas D, Arslan N, Assoun M, Atik Altinok Y, Barrio-Carreras D, Belanger Quintana A, Bernabei SM, Bontemps C, Boyle F, Bruni G, Bueno-Delgado M, Caine G, Carvalho R, Chrobot A, Chyz K, Cochrane B, Correia C, Corthouts K, Daly A, De Leo S, Desloovere A, De Meyer A, De Theux A, Didycz B, Dijsselhof ME, Dokoupil K, Drabik J, Dunlop C, Eberle-Pelloth W, Eftring K, Ekengren J, Errekalde I, Evans S, Foucart A, Fokkema L, Francois L, French M, Forssell E, Gingell C, Goncalves C, Gokmen Ozel H, Grimsley A, Gugelmo G, Gyure E, Heller C, Hensler R, Jardim I, Joost C, Jorg-Streller M, Jouault C, Jung A, Kanthe M, Koc N, Kok IL, Kozanoglu T, Kumru B, Lang F, Lang K, Liegeois I, Liguori A, Lilje R, Lubina O, Manta-Vogli P, Mayr D, Meneses C, Newby C, Meyer U, Mexia S, Nicol C, Och U, Olivas SM, Pedron-Giner C, Pereira R, Plutowska-Hoffmann K, Purves J, Re Dionigi A, Reinson K, Robert M, Robertson L, Rocha JC, Rohde C, Rosenbaum-Fabian S, Rossi A, Ruiz M, Saligova J, Gutierrez-Sanchez A, Schlune A, Schulpis K, Serrano-Nieto J, Skarpalezou A, Skeath R, Slabbert A, Straczek K, Gizewska M, Terry A, Thom R, Tooke A, Tuokkola J, van Dam E, van den Hurk TAM, van der Ploeg EMC, Vande Kerckhove K, Van Driessche M, van Wegberg AMJ, van Wyk K, Vasconcelos C, Velez Garcia V, Wildgoose J, Winkler T, Zolkowska J, Zuvadelli J, MacDonald A. Weaning practices in phenylketonuria vary between health professionals in Europe. Mol Genet Metab Rep. 2018 Nov 25;18:39-44. doi: 10.1016/j.ymgmr.2018.11.003. eCollection 2019 Mar. — View Citation
van Spronsen FJ, Blau N, Harding C, Burlina A, Longo N, Bosch AM. Phenylketonuria. Nat Rev Dis Primers. 2021 May 20;7(1):36. doi: 10.1038/s41572-021-00267-0. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in Evaluation Of Coping Attitudes (COPE) at week 10 | *COPE is a validated. The scale is a 4-point Likert type scale. While scoring the items, 1 point is given for "I Never Do This", 2 points for "I rarely do this", 3 points for "I do this way", and 4 points for "I Do This Mostly". There is no negative item in the scale. The highest score that can be obtained from the scale is 128, and the lowest score is 32. A high score from the scale means a high level of coping attitude, and a low score means a low level of coping attitude.
change = (Week 10 Score - Baseline Score) |
10 week | |
Secondary | Change from Baseline in Evaluation of the level of knowledge about PKU at week 1 | Form for Evaluation of Families' Knowledge Levels on Phenylketonuria:
*Question form prepared by the researcher in line with the literature; The level of knowledge of families about the disease and disease management of their child with PKU will be measured. The form consists of 20 questions.The increase in the mean of correct answers obtained in the form indicates that the level of knowledge about the disease is good. change = (Week 10 Score - Baseline Score) |
10 week |
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