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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180842
• Other study ID #: 0911-104
• Status: Completed
• Phase: Phase 2
• First received: May 25, 2010
• Last updated: February 13, 2014
• Start date: March 2010
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 18 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Yoga treatment program
yoga program designed specifically for the patient with CF

Locations

Country	Name	City	State
United States	Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve Quality of Life measured through self report questionnaires	Tool: CFQ-R	We expect this study to last one year.	No
Secondary	Reduce symptoms of pain measured through self report questionnaires	Tools: 1) MSAS and 2)Additional Pain Symptoms Questions	1 year	No
Secondary	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	No
Secondary	Reduce symptoms of sleep disturbance measured through self report questionnaires	tools: 1)MSAS and 2)CES-DC	1 year	No
Secondary	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	No