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

Neoplasms Clinical Trial

Official title:

Effects of Laugh-yoga Intervention on Mood and Quality of Life Among Oncologic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01156935
• Other study ID #: 0073-10-WOMC
• Status: Not yet recruiting
• Phase: N/A
• First received: July 1, 2010
• Last updated: July 9, 2010
• Start date: July 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2010
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Neoplasms

Intervention

Other:
• Laugh Yoga
1 hour including laugh, respiratory exercises and guided imagination by a group instructor specialized in laugh yoga

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life Questionnaire - QLQ-C30 & Positive-Negative Affect		Participants will fill QLQ-C30 & Positive -Negative Affect will be assessed before intervention and after three laugh - yoga sessions (that is after three weeks)	No
Secondary	Blood analysis for WBC, CRP, T&B Lymphocytes		Before intervention and after three laugh-yoga interventions, that is after three weeks.	No