- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01156935
Effects of Laugh-yoga Intervention on Mood and Quality of Life Among Oncologic Patients in a Oncologic Clinic Setting.
July 9, 2010 updated by: Wolfson Medical Center
Effects of Laugh-yoga Intervention on Mood and Quality of Life Among Oncologic Patients
Previous studies report low levels of mood and of quality of life among cancer patients.
Laugh has been proved to improve mood and immune system function.
The investigators propose to assess in a prospective randomised case-control study the affects of laugh-yoga intervention on mood levels and quality of life among cancer patients in a cancer clinic.
The main hypothesis is that patients in laugh-yoga group will report higher mood and quality o life levels after intervention in comparison with no-intervention group.
The second hypothesis is that immune system is the mediator of the effects of laugh-yoga intervention on mood and quality of life.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
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
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- oncologic patients treated in oncologic clinic in Wolfson MC,
- must be able to participate in Laugh Yoga session
Exclusion Criteria:
- psychiatric or cognitive impairment,
- deterioration in physical status,
- treatment discontinuation
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: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Laugh yoga
experimental laugh yoga
|
1 hour including laugh, respiratory exercises and guided imagination by a group instructor specialized in laugh yoga
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of Life Questionnaire - QLQ-C30 & Positive-Negative Affect
Time Frame: Participants will fill QLQ-C30 & Positive -Negative Affect will be assessed before intervention and after three laugh - yoga sessions (that is after three weeks)
|
Participants will fill QLQ-C30 & Positive -Negative Affect will be assessed before intervention and after three laugh - yoga sessions (that is after three weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood analysis for WBC, CRP, T&B Lymphocytes
Time Frame: Before intervention and after three laugh-yoga interventions, that is after three weeks.
|
Before intervention and after three laugh-yoga interventions, that is after three weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2010
Primary Completion (ANTICIPATED)
September 1, 2010
Study Completion (ANTICIPATED)
December 1, 2010
Study Registration Dates
First Submitted
July 1, 2010
First Submitted That Met QC Criteria
July 2, 2010
First Posted (ESTIMATE)
July 5, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
July 12, 2010
Last Update Submitted That Met QC Criteria
July 9, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0073-10-WOMC
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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