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

NCT ID: NCT06280261

Last Updated: 2024-02-28

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

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Recruitment Status

COMPLETED

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-27

Study Completion Date

2020-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Psychological Well-Being Caregiver Burden Life Stress

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Interventions

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

Scales and questionnaires

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Phenylketonuria patients

Exclusion Criteria

* BH4 metabolism disorde
* Other chronic illness
* Pregnancy
Minimum Eligible Age

6 Months

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Dilara Demirel

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serap Sivri, Prof

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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Hacettepe University

Ankara, Sihhiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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GO20/296

Identifier Type: -

Identifier Source: org_study_id

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