The Effect of Nursing Empowerment Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-24

Study Completion Date

2023-06-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pediatric Nursing Students' Self-efficacy Regarding Pediatric Medication Administration and, Clinical Comfort and Worry: A Study on a Two-group Pre-post-test Design Comparing Nurse and Peer Mentoring

NCT05771870

Medication Administration Mentoring Comfort

COMPLETED NA

The Effect of Peer Mentoring Program on Therapeutic Communication Skills of Students

NCT07105605

Nurse-Patient Relations Peer Mentoring Communication

COMPLETED NA

The Effect of Peer Education on the Knowledge and Skill Levels of Nursing Students

NCT06504745

Students Nursing

COMPLETED NA

The Effect of Occupation-Based Nursing Program Applied to Pediatric Oncology Patients

NCT04709653

Pediatric Cancer

COMPLETED NA

Determining the Effects of an Evidence-Based Practice Education Intervention Program Applied to Nursing Students

NCT06195397

Evidence-Based Practice

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Phenylketonuria is a disorder of phenylalanine metabolism and causes intellectual destruction if left untreated. It is an autosomal recessive metabolic disease that develops as a result of the absence of the enzyme phenylalanine hydroxylase (FAH), which provides the necessary amino acid metabolism for protein production in the body, which causes high phenylalanine in the blood. In our country, it is one of the places where PKU is commonly encountered (Çavuşoğlu, 2015; Hafid et al, 2015; Törner and Büyükgönenç, 2013). While the incidence of this disease in European countries is 1/10000-30000, it is 1/3000-4500 in our country (Alparslan, 2021). This situation is directly related to consanguineous marriages. It is stated that one out of every five marriages in our country is consanguineous marriage. If left untreated, it can cause extreme mental retardation, convulsions and death (Alparslan, 2021; Çavuşoğlu, 2015; Hafid et al, 2015; Törner and Büyükgönenç, 2013).

The care of the child with phenylketonuria is carried out by the parents. Extra care (diet therapy, control of blood phenylalanine level, etc.) for children in this diagnosis group is provided by their parents. The treatment and care process of children with PKU affects family routines, relationships and parenting styles. Parents of children experience emotional and economic burden. Therefore, it is stated that the care burden of parents in this diagnosis group is higher than that of healthy parents, and their quality of life is lower (Hatzmann et al, 2009). In addition, studies have shown that families of children with PKU have high levels of anxiety, depression (Mahmoudi-Gharaei et al. 2011) and stress (Irannejad et al. 2018). In another study; It is reported that the family's routines have changed (not eating in front of the child, not eating in restaurants, etc.) and that they experience anxiety about the effect of diet incompatibility on blood phenylalanine levels, feeling overwhelmed and guilt in the care process (Carpenter et al 2018). Therefore, having a child with PKU may affect coping attitudes.

Child health and diseases nurse should support children with PKU and their families on issues such as informing, training and counseling about the disease and its management.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Phenylketonurias

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

Family education

Group Type EXPERIMENTAL

Family education

Intervention Type 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.

Control group

No training will be given.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Family education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes