NCT00166231

Brief Summary

The causes of pediatric pain are often not the same for every child. Most children who visit a cardiology specialist with complaints of chest or other somatic pain have no known medical diagnosis to explain their symptoms. These children and their families often leave with no explanation for the child's distress. This early study will ask parents and children specific questions related to the stress in their lives, their emotional well-being and the children's physical functioning. The investigators want children who experience chest and other somatic pain, and those who do not, to be in their study so that they can look at both groups. The investigators hope to use these answers to better inform cardiologists who often work with children with non-cardiac pain and, in turn, help them to better serve their patients. Ultimately, the investigators hope that the answers they get will provide answers to these families. They also hope to use the results of this study to put together a short screener for the cardiologist to give to pediatric patients with complaints of chest or other somatic pain to help the cardiologists better understand their patients' symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2004

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 25, 2015

Status Verified

February 1, 2015

Enrollment Period

5.8 years

First QC Date

September 13, 2005

Last Update Submit

February 24, 2015

Conditions

Keywords

Innocent heart murmursChest painpediatric CardiologySomatizationlife stress

Outcome Measures

Primary Outcomes (1)

  • Change in Children Depression Inventory

    Children Depression Inventory (CDI) is a 27-item self-report scale of depressive symptoms suitable for use by youth ranging from 7 to 17 years. The 27 items on the assessment are grouped into five major factor areas. The item score are rated 0-2 with a total scores summed and converted to T scores. The total T score ranges from 33 to 100 with high scores indicating higher levels of depressive symptoms.

    Baseline, 4 weeks

Study Arms (2)

Chest pain patients

Murmur group

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

enrolling pediatric patients with either chest pain or innocent heart murmur referrals

You may qualify if:

  • years of age
  • Pediatric patients with referrals for innocent heart murmurs
  • Pediatric patients experiencing chest pain
  • English speaking

You may not qualify if:

  • Non English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Childrens Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

Location

Sibley Heart Center Cardiology

Atlanta, Georgia, 30341, United States

Location

Related Publications (5)

  • Blount RL, Morris JA, Cheng PS, Campbell RM, Brown RT. Parent and child psychological factors in pediatric syncope and other somatic symptoms. J Consult Clin Psychol. 2004 Aug;72(4):597-604. doi: 10.1037/0022-006X.72.4.597.

    PMID: 15301644BACKGROUND
  • Claar RL, Walker LS, Smith CA. Functional disability in adolescents and young adults with symptoms of irritable bowel syndrome: the role of academic, social, and athletic competence. J Pediatr Psychol. 1999 Jun;24(3):271-80. doi: 10.1093/jpepsy/24.3.271.

    PMID: 10379142BACKGROUND
  • Cohen LL, Blount RL, Cohen RJ, Schaen ER, Zaff JF. Comparative study of distraction versus topical anesthesia for pediatric pain management during immunizations. Health Psychol. 1999 Nov;18(6):591-8. doi: 10.1037//0278-6133.18.6.591.

    PMID: 10619532BACKGROUND
  • Massin MM, Bourguignont A, Coremans C, Comte L, Lepage P, Gerard P. Chest pain in pediatric patients presenting to an emergency department or to a cardiac clinic. Clin Pediatr (Phila). 2004 Apr;43(3):231-8. doi: 10.1177/000992280404300304.

    PMID: 15094947BACKGROUND
  • Lam JC, Tobias JD. Follow-up survey of children and adolescents with chest pain. South Med J. 2001 Sep;94(9):921-4.

    PMID: 11592755BACKGROUND

MeSH Terms

Conditions

Chest PainStress, Psychological

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Robert M Campbell, MD

    Emory University

    PRINCIPAL INVESTIGATOR
  • Ronald L. Blount, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR
  • Greg Johnson, MD

    Emory University

    PRINCIPAL INVESTIGATOR
  • Rose Cummings, DO

    Emory University

    PRINCIPAL INVESTIGATOR
  • Patty Simpson, MSN

    Emory University

    PRINCIPAL INVESTIGATOR
  • Kenneth Dooley, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 14, 2005

Study Start

March 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 25, 2015

Record last verified: 2015-02

Locations