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

Stroke Clinical Trial

Official title:

A Single-Arm Prospective Investigation of the Effects of Laughter Therapy on Mood, Stress, and Self-Efficacy in People With Central Nervous System Disorders.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750982
• Other study ID #: TRBROWN201601
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 2018

Study information

• Verified date: September 2018
• Source: Brown, Theodore R., M.D., MPH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Amyotrophic Lateral Sclerosis
• Brain Injuries
• Brain Injury
• Huntington Disease
• Huntington's Disease
• Motor Neuron Disease
• Multiple Sclerosis
• Parkinson Disease
• Parkinson's Disease
• Sclerosis
• Spinal Cord Injuries
• Spinal Cord Injury
• Stroke
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Evergreen Healthcare	Kirkland	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Brown, Theodore R., M.D., MPH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire (PHQ-9, for depression)	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).	Change from Baseline to 8 weeks
Primary	Generalized Anxiety Disorder 7-item scale (GAD-7, for anxiety)	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).	Change from Baseline to 8 weeks
Secondary	The General Self-Efficacy Scale (GSE)	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).	Change from Baseline to 8 weeks