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

Caregiver Burden Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06280261
• Other study ID #: GO20/296
• Status: Completed
• Start date: May 27, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: February 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Gender: All
• Age group: 6 Months to 35 Years

Eligibility

Inclusion Criteria:

• Phenylketonuria patients

Exclusion Criteria:

• BH4 metabolism disorde

• Other chronic illness

• Pregnancy

Related Conditions & MeSH terms

• Caregiver Burden
• Life Stress
• Phenylketonurias
• Psychological Well-Being
• Stress, Psychological

Intervention

Other:
• parenting stress index, Zarit burden scale, Rosenberg self esteem scale, stait trait anxiety inventory, struggles and difficulties questionnaire
Scales and questionnaires

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Sihhiye

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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