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Completed

NCT Number: NCT06280261

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

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

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Key information

Conditions

Psychological Well-being Behavior Behavioral Symptoms Caregiver Burden Life Stress Personal Satisfaction Stress, Psychological

Age range

6 month–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Sihhiye, 06100, Turkey (Türkiye)

About this study

Study Design: Between January 2020 - June 2020, a total of 156 phenylketonuria patients and their parents who arrived for their regular examinations were included. Parents were asked to fill the parenting stress index, Zarit burden scale and the strengths and difficulties questionnaire and children over the age of eleven were asked to fill the Rosenberg self-esteem scale, the stait-trait anxiety inventory and strengths and difficulties questionnaire.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Phenylketonuria patients

Exclusion criteria

  • BH4 metabolism disorde
  • Other chronic illness
  • Pregnancy

Treatment and study plan

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

Other

Scales and questionnaires

Primary outcomes

  1. Rosenberg Self-Esteem Scale

    Time frame: 12 minutes

    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.

  2. Stait trait anxiety inventory

    Time frame: 45 minutes

    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.

  3. Strenghts and difficulties questionnaire

    Time frame: 30 minutes

    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

  4. Zarit burden scale

    Time frame: 25 minutes

    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.

  5. Parenting stress index

    Time frame: 20 minutes

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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