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Laughter Therapy Effects on Mood, Stress and Self-efficacy in People With Neurological Diseases.

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ClinicalTrials.gov Identifier: NCT02750982
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Theodore R Brown, Brown, Theodore R., M.D., MPH

April 21, 2016
April 26, 2016
September 26, 2018
July 2016
August 2018   (Final data collection date for primary outcome measure)
  • Patient Health Questionnaire (PHQ-9, for depression) [ Time Frame: Change from Baseline to 8 weeks ]
    Outcome measures will be completed at baseline, active-phase completion at week 8 and post-active phase week 8 (16 weeks post-start of active phase).
  • Generalized Anxiety Disorder 7-item scale (GAD-7, for anxiety) [ Time Frame: Change from Baseline to 8 weeks ]
    Outcome measures will be completed at baseline, active-phase completion at week 8 and post-active phase week 8 (16 weeks post-start of active phase).
Same as current
Complete list of historical versions of study NCT02750982 on ClinicalTrials.gov Archive Site
The General Self-Efficacy Scale (GSE) [ Time Frame: Change from Baseline to 8 weeks ]
Outcome measures will be completed at baseline, active-phase completion at week 8 and post-active phase week 8 (16 weeks post-start of active phase).
Same as current
Not Provided
Not Provided
 
Laughter Therapy Effects on Mood, Stress and Self-efficacy in People With Neurological Diseases.
A Single-Arm Prospective Investigation of the Effects of Laughter Therapy on Mood, Stress, and Self-Efficacy in People With Central Nervous System Disorders.
This is a prospective investigation of the effects of Laughter therapy (LT) on perceived stress, self-efficacy, mood and other wellness measures in people with the following neurological conditions: Alzheimer's disease, amyotrophic lateral sclerosis, brain injury, Huntington's Disease, multiple sclerosis, Parkinson's Disease, post-stroke, spinal cord injury.
Laughter therapy (LT) has potential benefits in treating illness. It combines laughter with breathing and body exercises to stimulate laughter, both real and artificial, in a group setting. Laughter therapy may help treating illness by strengthening breathing muscles, improving mood, and providing pain and stress relief. EvergreenHealth has presented laughter therapy classes to patients with Parkinson's disease and Multiple sclerosis and other neurological conditions. The therapy will be led by a certified laughter therapist and mental health professional.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Alzheimer's Disease
  • Amyotrophic Lateral Sclerosis
  • Brain Injury
  • Huntington's Disease
  • Multiple Sclerosis
  • Parkinson's Disease
  • Stroke
  • Spinal Cord Injury
Other: Laughter Therapy
Laughter Therapy (LT) involves simple exercises using playfulness, eye contact and chanting in forms of laughter. LT will be taught by a certified LT instructor in a group session. There will be 8 sessions per group with each session attended by 8-12 participants and lasting 60 minutes
Experimental: Laughter therapy
effects of Laughter therapy (LT) on mood, self-efficacy and other wellness measures in people with neurological conditions.
Intervention: Other: Laughter Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Same as current
August 2018
August 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis based on medical record review of one of the following neurological diseases: Alzheimer's disease, amyotrophic lateral sclerosis, brain injury, Huntington's Disease, Multiple Sclerosis, Parkinson's Disease, Post-Stroke, Spinal Cord Injury.
  • Medically stable for at least 2 months.
  • Not participating in Laughter therapy for 30 days prior to screening.

Exclusion Criteria:

  • Females who are pregnant
  • Any unstable medical condition
  • Severe cognitive deficits that would interfere with participation (e.g. unable to follow commands).
  • Severe abdominal pain, chest pain or back pain.
  • Abdominal, chest or back surgery within 90 days.
  • Psychosis or severe mental illness.
  • Untreated hernia.
  • Persistent cough.
  • Advanced hemorrhoids.
  • Epilepsy.
  • Uncontrolled Hypertension - SBP >170 or DBP >105.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02750982
TRBROWN201601
No
Not Provided
Plan to Share IPD: No
Theodore R Brown, Brown, Theodore R., M.D., MPH
Brown, Theodore R., M.D., MPH
Not Provided
Principal Investigator: Theodore R Brown, MD, MPH Evergreen Healthcare
Brown, Theodore R., M.D., MPH
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP