The Effect of Nursing Empowerment Program

NCT05497050 | Completed

• 1 other identifier: FAHRİ AŞKAN PHD THESIS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Phenylketonurias

Keywords

family; Coping; Education; Phenylketonuria(PKU); Empowerment; Nursing.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from Baseline in Evaluation of the level of knowledge about PKU at week 1

  10 week

Study Arms (2)

Experimental group

EXPERIMENTAL

Family education

Behavioral: Family education

Control group

NO INTERVENTION

No training will be given.

Interventions

Family education BEHAVIORAL

By calling the families in the experimental group by phone; Nursing interventions for family empowerment will last for 10 weeks, they will be invited to the Family Health Center (FHC) or child metabolism polyclinic twice in this process, they will be called once a week (with 2 phone calls) for two weeks after the face-to-face training initiative in the first stage, In the second stage, at the end of the face-to-face training, they will be informed that they will be called once a week for two weeks (4 phone calls in total). The families in the experimental group will be informed that 4 weeks after the completion of the training and phone calls (at the 10th week), they will call the FHC or the pediatric metabolism polyclinic again for the application of the post-tests and that the nursing training for family empowerment will be completed.

Experimental group

Eligibility Criteria

• Age: 1 Day - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Residing in Van and/or being followed up in the pediatric metabolism polyclinic,
• Agreeing to participate in the research,
• literate,
• Speaking and understanding Turkish,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Van Yuzuncu Yıl University

Van, Tuşba, 65080, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 16763891 BACKGROUND

• 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.

  PMID: 30705824 BACKGROUND

• 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.

  PMID: 34017006 BACKGROUND

MeSH Terms

Conditions

Phenylketonurias; Empowerment

Interventions

Sex Education

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Sexology; Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• Şenay ÇETİNKAYA, Doç. Dr.

  Cukurova University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: The study was completed with the families of 36 children with PKU, 19 in the intervention group and 17 in the control group, who met the inclusion criteria.

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: November 24, 2021
• Primary Completion: February 28, 2023
• Study Completion: June 22, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

TU (1)