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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01180842
Enrollment
20
Registered
2010-08-12
Start date
2010-03-31
Completion date
2013-12-31
Last updated
2014-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

CF

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.

Interventions

OTHERYoga treatment program

yoga program designed specifically for the patient with CF

Sponsors

Children's Hospitals and Clinics of Minnesota
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Improve Quality of Life measured through self report questionnairesWe expect this study to last one year.Tool: CFQ-R

Secondary

MeasureTime frameDescription
Reduce symptoms of pain measured through self report questionnaires1 yearTools: 1) MSAS and 2)Additional Pain Symptoms Questions
Reduce symptoms of anxiety measured through self report questionnaires and cortisol testing1 yearAssessed through 1)Saliva cortisol testing and 2)tools:STAIC and HADS
Reduce symptoms of sleep disturbance measured through self report questionnaires1 yeartools: 1)MSAS and 2)CES-DC
Reduce symptoms of depression measured through self report questionnaires and cortisol testing1 yeartools: 1)CES-DC, 2) HADS and 3) saliva cortisol testing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026