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Effects of Laugh-yoga Intervention on Mood and Quality of Life Among Oncologic Patients in a Oncologic Clinic Setting.

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ClinicalTrials.gov Identifier: NCT01156935
Recruitment Status : Unknown
Verified July 2010 by Wolfson Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 5, 2010
Last Update Posted : July 12, 2010
Sponsor:
Information provided by:
Wolfson Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasms Other: Laugh Yoga Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Laugh-yoga Intervention on Mood and Quality of Life Among Oncologic Patients
Study Start Date : July 2010
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : December 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Blood analysis for WBC, CRP, T&B Lymphocytes [ Time Frame: Before intervention and after three laugh-yoga interventions, that is after three weeks. ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Dr. Yossef Brener, Wolfson MC
ClinicalTrials.gov Identifier: NCT01156935     History of Changes
Other Study ID Numbers: 0073-10-WOMC
First Posted: July 5, 2010    Key Record Dates
Last Update Posted: July 12, 2010
Last Verified: July 2010

Keywords provided by Wolfson Medical Center:
Neoplasm
Laugh-Yoga
Mood
Quality of life