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

NCT01180842 | Completed Phase 2

• 1 other identifier: 0911-104
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

CF

Outcome Measures

Primary Outcomes (1)

• Improve Quality of Life measured through self report questionnaires

  Tool: CFQ-R

  We expect this study to last one year.

Secondary Outcomes (4)

• Reduce symptoms of pain measured through self report questionnaires

  1 year

• Reduce symptoms of anxiety measured through self report questionnaires and cortisol testing

  1 year

• Reduce symptoms of sleep disturbance measured through self report questionnaires

  1 year

• Reduce symptoms of depression measured through self report questionnaires and cortisol testing

  1 year

Study Arms (1)

Alternative Treatment

OTHER

The CF Patient Population receiving the specific yoga study treatment

Other: Yoga treatment program

Interventions

Yoga treatment program OTHER

yoga program designed specifically for the patient with CF

Alternative Treatment

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• John McNamara, MD

  Children's Hospitals and Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: August 12, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

US (1)