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NCT Number: NCT01180842

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

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.

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Key information

Conditions

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

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yoga treatment program

Other

yoga program designed specifically for the patient with CF

Primary outcomes

  1. Improve Quality of Life measured through self report questionnaires

    Time frame: We expect this study to last one year.

    Tool: CFQ-R

Secondary outcomes

  1. Reduce symptoms of pain measured through self report questionnaires

    Time frame: 1 year

    Tools: 1) MSAS and 2)Additional Pain Symptoms Questions

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

    Time frame: 1 year

    Assessed through 1)Saliva cortisol testing and 2)tools:STAIC and HADS

  3. Reduce symptoms of sleep disturbance measured through self report questionnaires

    Time frame: 1 year

    tools: 1)MSAS and 2)CES-DC

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

    Time frame: 1 year

    tools: 1)CES-DC, 2) HADS and 3) saliva cortisol testing

Sponsors and collaborators

Lead sponsor

Children's Hospitals and Clinics of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 12, 2010
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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