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

February 13, 2014 updated by: Children's Hospitals and Clinics of Minnesota

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals and Clinics of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Alternative Treatment
The CF Patient Population receiving the specific yoga study treatment
Other: Yoga treatment program
yoga program designed specifically for the patient with CF

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduce symptoms of pain measured through self report questionnaires
Time Frame: 1 year
Tools: 1) MSAS and 2)Additional Pain Symptoms Questions
1 year
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
1 year
Reduce symptoms of sleep disturbance measured through self report questionnaires
Time Frame: 1 year
tools: 1)MSAS and 2)CES-DC
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospitals and Clinics of Minnesota

Investigators

  • Principal Investigator: John McNamara, MD, Children's Hospitals and Clinics of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

August 11, 2010

First Posted (ESTIMATE)

August 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2014

Last Update Submitted That Met QC Criteria

February 13, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0911-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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