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

C

Children's Hospitals and Clinics of Minnesota

Status and phase

Completed
Phase 2

Conditions

Cystic Fibrosis

Treatments

Other: Yoga treatment program

Study type

Interventional

Funder types

Other

Identifiers

NCT01180842
0911-104

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

9 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Alternative Treatment
Other group
Description:
The CF Patient Population receiving the specific yoga study treatment
Treatment:
Other: Yoga treatment program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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