Effects of Laugh-yoga Intervention on Mood and Quality of Life Among Oncologic Patients in a Oncologic Clinic Setting.
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Wolfson Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Wolfson Medical Center
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01156935
First received: July 1, 2010
Last updated: July 9, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Neoplasms |
Other: Laugh Yoga |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Effects of Laugh-yoga Intervention on Mood and Quality of Life Among Oncologic Patients |
Resource links provided by NLM:
Further study details as provided by Wolfson Medical Center:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Blood analysis for WBC, CRP, T&B Lymphocytes [ Time Frame: Before intervention and after three laugh-yoga interventions, that is after three weeks. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Laugh yoga
experimental laugh yoga
|
Other: Laugh Yoga
1 hour including laugh, respiratory exercises and guided imagination by a group instructor specialized in laugh yoga
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Dr. Yossef Brener, Wolfson MC |
| ClinicalTrials.gov Identifier: | NCT01156935 History of Changes |
| Other Study ID Numbers: | 0073-10-WOMC |
| Study First Received: | July 1, 2010 |
| Last Updated: | July 9, 2010 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Wolfson Medical Center:
|
Neoplasm Laugh-Yoga Mood Quality of life |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013