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NCT00824278 · ClinicalTrials.gov registry record

The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory Pilot Study

A clinical trial, sponsored by National Institute of Mental Health (NIMH).

Completed
Registry status
289
Enrollment target

NCT00824278: Completed study, sponsored by National Institute of Mental Health (NIMH).

NCT00824278 is a clinical trial that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 289 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00824278 has completed, sponsored by National Institute of Mental Health (NIMH).

COMPLETED
Registry status
289 participants
Enrollment target

Study Summary

Medical illnesses and treatments can cause distress in patients, and medical professionals are very interested in identifying distress quickly to ensure that a patient can receive appropriate support and treatment. Adult patients often use a screening tool known as the Distress Thermometer to indicate the causes and levels of distress they feel. However, little work has been done on how to assess distress in pediatric patients. This study will investigate the effectiveness of the Distress Thermometer as a tool to accurately measure distress in pediatric patients, and determine whether primary caregivers and physicians can also use the Distress Thermometer to accurately gauge a patient s levels and sources of distress. The study will also investigate the effectiveness of the Distress Thermometer compared with other means of measuring fatigue, mood, and pain levels. This study will include approximately 90 patients between 7 and 21 years of age who are currently enrolled in a National Institutes of Health pediatric research study. It will also include responses from the primary caregivers and primary medical providers of the patients involved in the study. All patients will complete the Distress Thermometer s self-reported distress scale and other standardized measures of anxiety, depression, fatigue, and pain. In addition, patients between 18 and 21 years of age will be asked to assess the benefits and negative effects of participating in psychosocial research. On the same day, the patient s primary caregiver and primary medical provider will complete a Distress Thermometer survey to estimate the patient s distress level. If either the patient or the primary caregiver indicate high levels of distress or mood symptoms, the researchers will offer them an opportunity to speak with a mental health professional. The primary medical provider will also receive a copy of the responses reported on the patient s Distress Thermometer.

Trial Details

FieldValue
Enrollment Target 289 participants
Start Date 2009-01-13
Est. Completion 2018-05-31

What the finished NCT00824278 record still lists

NCT00824278 is an observational study that tracks outcomes without assigning an intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT00824278 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00824278 about?

NCT00824278 is a clinical study titled "The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory Pilot Study". Medical illnesses and treatments can cause distress in patients, and medical professionals are very interested in identifying distress quickly to ensure that a patient can receive appropriate support and treatment. Adult patients often use a screening tool known as the Distress Thermometer to indica...

What is the current status of trial NCT00824278?

This trial is currently completed. The enrollment target is 289 participants. The study started on 2009-01-13. Estimated completion is 2018-05-31.

Who is sponsoring clinical trial NCT00824278?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00824278, the US trial registry maintained by the National Library of Medicine. NCT00824278 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.