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

Phase 2

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: Yoga treatment program

• Registration Number: NCT01180842
• Lead Sponsor: Children's Hospitals and Clinics of Minnesota

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-13
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alternative Treatment	Yoga treatment program	The CF Patient Population receiving the specific yoga study treatment

Primary Outcome Measures

Name	Time	Method
Improve Quality of Life measured through self report questionnaires	We expect this study to last one year.	Tool: CFQ-R

Secondary Outcome Measures

Name	Time	Method
Reduce symptoms of sleep disturbance measured through self report questionnaires	1 year	tools: 1)MSAS and 2)CES-DC
Reduce symptoms of pain measured through self report questionnaires	1 year	Tools: 1) MSAS and 2)Additional Pain Symptoms Questions
Reduce symptoms of anxiety measured through self report questionnaires and cortisol testing	1 year	Assessed through 1)Saliva cortisol testing and 2)tools:STAIC and HADS
Reduce symptoms of depression measured through self report questionnaires and cortisol testing	1 year	tools: 1)CES-DC, 2) HADS and 3) saliva cortisol testing

Trial Locations

Locations (1)

Children's Hospitals and Clinics of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States