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

Study Overview
=================
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.

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.

Official Title
-----------------
Treatment of Anxiety/Depression and Pain Through Relaxation Yoga for Patient With CF

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: Yoga treatment program


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Alternative Treatment<br>The CF Patient Population receiving the specific yoga study treatment | Other: Yoga treatment program<br>* yoga program designed specifically for the patient with CF<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve Quality of Life measured through self report questionnaires | Tool: CFQ-R | We expect this study to last one year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce symptoms of pain measured through self report questionnaires | Tools: 1) MSAS and 2)Additional Pain Symptoms Questions | 1 year | 
| Reduce symptoms of anxiety measured through self report questionnaires and cortisol testing | Assessed through 1)Saliva cortisol testing and 2)tools:STAIC and HADS | 1 year | 
| Reduce symptoms of sleep disturbance measured through self report questionnaires | tools: 1)MSAS and 2)CES-DC | 1 year | 
| Reduce symptoms of depression measured through self report questionnaires and cortisol testing | tools: 1)CES-DC, 2) HADS and 3) saliva cortisol testing | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CF