Clinical trial NCT01180842: Treatment of Anxiety/Depression and Pain Through Relaxation Yoga for Patient With Cystic Fibrosis (CF)
Official title: Treatment of Anxiety/Depression and Pain Through Relaxation Yoga for Patient With CF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: CF
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2010-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Improve Quality of Life measured through self report questionnaires
timeFrame: We expect this study to last one year.
Secondary outcomes:
measure: Reduce symptoms of pain measured through self report questionnaires
timeFrame: 1 year
measure: Reduce symptoms of anxiety measured through self report questionnaires and cortisol testing
timeFrame: 1 year
measure: Reduce symptoms of sleep disturbance measured through self report questionnaires
timeFrame: 1 year
measure: Reduce symptoms of depression measured through self report questionnaires and cortisol testing
timeFrame: 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
Study officials:
affiliation: Children's Hospitals and Clinics of Minnesota
name: John McNamara, MD
role: PRINCIPAL_INVESTIGATOR
References: