The Struggle That Is Phenylketonuria : What Do The Patients and Caregivers Suffer From

NCT06280261 | Completed

• 1 other identifier: GO20/296
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To assess the stress levels and life hardships of phenylketonuria patients and their parents.

Conditions

Psychological Well-Being; Caregiver Burden; Life Stress

Outcome Measures

Primary Outcomes (5)

• Rosenberg Self-Esteem Scale

  Rosenberg Self-Esteem Scale was developed by Morris Rosenberg in 1960. It evaluates self-esteem and consists of 10 items in total. In the Likert-type scale, which includes positively and negatively charged items, 0-1 points are considered as high self-esteem, 2-4 points as medium self-esteem, and 5-6 points as low self-esteem.

  12 minutes

• Stait trait anxiety inventory

  State-Trait Anxiety Inventory is an inventory that measures state and trait anxiety levels of children. It has been developed by Spielberges et. al in 1983. It consists of two questionnaires with a total of 40 questions, 20 that assesses the anxiety level stately, that is, how the child feels at that moment, and 20 that assesses how he feels constantly, that is, in general. The scale is in 3-point Likert type and is evaluated with 1-3 points according to symptom severityThe lowest score that can be obtained from the scales is 20, and the highest score is 60, higher scores indicate higher anxiety.

  45 minutes

• Strenghts and difficulties questionnaire

  Strengths and Difficulties Questionnaire was developed by Goodman in 1997 to assess children's social, emotional and behavioral difficulties. There is a parent form for ages 4-17 and a child form for ages 11-17. It consists of 25 questions in total

  30 minutes

• Zarit burden scale

  Zarit Burden Scale was developed by Zarit et al. in 1980. It is a 5-point Likert-type scale consisting of 22 questions that aims to measure the distress experienced by caregivers. Answers are scored between 0-4. A minimum of 0 and a maximum of 88 points can be obtained from the scale. The high score indicates the height of the distress experienced.

  25 minutes

• Parenting stress index

  Parenting Stress Index aims to measure the stress experienced by parents in their relationships with their children. It is a 4-point Likert-type scale consisting of 16 questions in total. A minimum of 16 and a maximum of 64 points can be obtained from the scale. A high score from the scale indicates that parental stress is high.

  20 minutes

Interventions

parenting stress index, Zarit burden scale, Rosenberg self esteem scale, stait trait anxiety inventory, struggles and difficulties questionnaire OTHER

Scales and questionnaires

Eligibility Criteria

• Age: 6 Months - 35 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study was carried out at Hacettepe University, İhsan Doğramacı Children's Hospital, Department of Metabolism, between January 2020 and June 2020. It was planned to include patients who were followed up with the diagnosis of phenylketonuria with diet or Sapropterin hydrochloride therapy, who didn't have BH4 metabolism disorder or any other health problem. Pregnant patients were also excluded

You may qualify if:

• Phenylketonuria patients

You may not qualify if:

• BH4 metabolism disorde
• Other chronic illness
• Pregnancy

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Sihhiye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Well-Being; Caregiver Burden; Stress, Psychological

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Serap Sivri, Prof

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 10, 2024
• First Posted: February 28, 2024
• Study Start: May 27, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

TU (1)