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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180842
First Posted: August 12, 2010
Last Update Posted: February 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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. ]
    Tool: CFQ-R


Secondary Outcome Measures:
  • Reduce symptoms of pain measured through self report questionnaires [ Time Frame: 1 year ]
    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 ]
    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 ]
    tools: 1)MSAS and 2)CES-DC

  • Reduce symptoms of depression measured through self report questionnaires and cortisol testing [ Time Frame: 1 year ]
    tools: 1)CES-DC, 2) HADS and 3) saliva cortisol testing


Enrollment: 20
Study Start Date: March 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01180842     History of Changes
Other Study ID Numbers: 0911-104
First Submitted: May 25, 2010
First Posted: August 12, 2010
Last Update Posted: February 14, 2014
Last Verified: February 2014

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

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