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

NCT ID: NCT01180842

Last Updated: 2014-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-12-31

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alternative Treatment

The CF Patient Population receiving the specific yoga study treatment

Group Type: OTHER

Yoga treatment program

Intervention Type: OTHER

yoga program designed specifically for the patient with CF

Interventions

Yoga treatment program

yoga program designed specifically for the patient with CF

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospitals and Clinics of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John McNamara, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospitals and Clinics of Minnesota

Locations

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

0911-104

Identifier Type: -

Identifier Source: org_study_id