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Treatment of Anxiety/Depression and Pain Through Relaxation Yoga for Patient With Cystic Fibrosis (CF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01180842
First received: May 25, 2010
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  Purpose

The investigators research question is whether or not yoga effectively alleviates symptoms of pain, sleep disturbance, anxiety and depression in children with cystic fibrosis. If yoga does prove to be effective, the investigators will educate our CF population about the benefits they may experience if they choose to incorporate yoga into their CF therapy. The investigators will also go on to do further research of other complementary alternative medicine therapies.

This is a pre/post-test study with 20 subjects. The subjects will serve as their own controls. Each subject will participate in six yoga sessions over a ten week period. Subjects' symptoms will be evaluated with the use of questionnaires. The investigators will also test cortisol levels on weeks -2, -1, 1, 6, 7, 8. Cortisol is a hormone that is affected by stress. Testing of cortisol throughout the study will help us determine the subjects' stress level throughout the study.


Condition Intervention Phase
Cystic Fibrosis
 Other: Yoga treatment program
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Anxiety/Depression and Pain Through Relaxation Yoga for Patient With CF

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • Improve Quality of Life measured through self report questionnaires [ Time Frame: We expect this study to last one year. ] [ Designated as safety issue: No ]
    Tool: CFQ-R


Secondary Outcome Measures:
  • Reduce symptoms of pain measured through self report questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Tools: 1) MSAS and 2)Additional Pain Symptoms Questions

  • Reduce symptoms of anxiety measured through self report questionnaires and cortisol testing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessed through 1)Saliva cortisol testing and 2)tools:STAIC and HADS

  • Reduce symptoms of sleep disturbance measured through self report questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    tools: 1)MSAS and 2)CES-DC

  • Reduce symptoms of depression measured through self report questionnaires and cortisol testing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    tools: 1)CES-DC, 2) HADS and 3) saliva cortisol testing


Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Alternative Treatment
The CF Patient Population receiving the specific yoga study treatment
 Other: Yoga treatment program
yoga program designed specifically for the patient with CF

Detailed Description:

H1: The implementation of a yoga therapy program decreases symptoms of pain within our CF population.

H2: The implementation of a yoga therapy program decreases symptoms of sleep disturbance within our CF population.

H3: The implementation of a yoga therapy program decreases symptoms of anxiety within our CF population.

H4: The implementation of a yoga therapy program decreases symptoms of depression within our CF population.

  Eligibility

Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Positive diagnosis of CF
  • Males or females within the ages of 9 and 18

Exclusion Criteria:

  • No positive diagnosis of CF
  • Younger than 9 years of age or older than 18 years of age
  • Concomitant illness or disease that may inhibit the patient's ability to participate in the study as determined by the principal investigator
  • The patient has participated in an investigational treatment study 30 days prior to pre-session week -2.
  • The patient is currently participating in yoga sessions one or more times per week.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180842

Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
Principal Investigator: John McNamara, MD Children's Hospitals and Clinics of Minnesota
  More Information

No publications provided

Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01180842     History of Changes
Other Study ID Numbers: 0911-104
Study First Received: May 25, 2010
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospitals and Clinics of Minnesota:
CF

Additional relevant MeSH terms:
Cystic Fibrosis
Depression
Depressive Disorder
Fibrosis
Dysthymic Disorder
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013