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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Yoga treatment program
Sponsored by
Children's Hospitals and Clinics of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring CF

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Children's Hospitals and Clinics of Minnesota

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Alternative Treatment

Arm Description

The CF Patient Population receiving the specific yoga study treatment

Outcomes

Primary Outcome Measures

Improve Quality of Life measured through self report questionnaires
Tool: CFQ-R

Secondary Outcome Measures

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

Full Information

First Posted
May 25, 2010
Last Updated
February 13, 2014
Sponsor
Children's Hospitals and Clinics of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01180842
Brief Title
Treatment of Anxiety/Depression and Pain Through Relaxation Yoga for Patient With Cystic Fibrosis (CF)
Official Title
Treatment of Anxiety/Depression and Pain Through Relaxation Yoga for Patient With CF
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
CF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alternative Treatment
Arm Type
Other
Arm Description
The CF Patient Population receiving the specific yoga study treatment
Intervention Type
Other
Intervention Name(s)
Yoga treatment program
Intervention Description
yoga program designed specifically for the patient with CF
Primary Outcome Measure Information:
Title
Improve Quality of Life measured through self report questionnaires
Description
Tool: CFQ-R
Time Frame
We expect this study to last one year.
Secondary Outcome Measure Information:
Title
Reduce symptoms of pain measured through self report questionnaires
Description
Tools: 1) MSAS and 2)Additional Pain Symptoms Questions
Time Frame
1 year
Title
Reduce symptoms of anxiety measured through self report questionnaires and cortisol testing
Description
Assessed through 1)Saliva cortisol testing and 2)tools:STAIC and HADS
Time Frame
1 year
Title
Reduce symptoms of sleep disturbance measured through self report questionnaires
Description
tools: 1)MSAS and 2)CES-DC
Time Frame
1 year
Title
Reduce symptoms of depression measured through self report questionnaires and cortisol testing
Description
tools: 1)CES-DC, 2) HADS and 3) saliva cortisol testing
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John McNamara, MD
Organizational Affiliation
Children's Hospitals and Clinics of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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