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
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01156935
First received: July 1, 2010
Last updated: July 9, 2010
Last verified: July 2010
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014