Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001130651
Ethics application status
Approved
Date submitted
15/10/2014
Date registered
23/10/2014
Date last updated
23/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intradialytic Laughter Yoga therapy for haemodialysis patients: A pre-post intervention feasibility study
Scientific title
The effect of laughter yoga during dialysis on psychological measures for people on haemodialysis.
Secondary ID [1] 285497 0
Nil
Universal Trial Number (UTN)
U1111-1162-8983
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease 293286 0
Condition category
Condition code
Renal and Urogenital 293555 293555 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trained Laughter Yoga therapists will provide 12 sessions of laughter yoga over a four week period (3 sessions per week). Each session will run for a total of 30 minutes. Firstly breathing and stretching exercises for 10 minutes consisting of: Deep belly breathing; body stretching, arms and legs; gentle neck and shoulder stretches, for example turning the head to the right and left; smiling, for example: think of something pleasant and smile and loosening up the face muscles; throat/chest/belly laugh exercise. This part aims to teach participants how to breathe deeper and more effectively to enhance oxygenation levels; ie from a shallow style of breathing to slower, deeper breathing, with the laughter eventually coming from the core. The second ten minute section will consist of facilitated laughter exercises, in conjunction with chanting ho, ho, ho, ha, ha, ha, and (one hand) clapping or slapping of the thigh (10 minutes) Facilitated laughs in this order include: greeting laugh; handshaking with therapists, and waving to others; Mexican wave; aloha laugh which is synchronized as a group; triathlon laugh (combination of running, swimming, cycling laughs); clock watching laugh; shower laugh; brushing teeth laugh; cup of tea laugh. The final 10 minutes will consist of Laughter Meditation (10 minutes) where participants are guided through a laughter meditation consisting of: body relaxing; smiling and relaxing; giggle; freestyle laughter exercise; breathing and relaxing and ending with application of ‘laughter lotion’.
Monitoring of adherence is attended to by documenting which participants undertook full intervention. Thisis straight forward as participants are all attending their usual dialysis sessions.
Intervention code [1] 290436 0
Rehabilitation
Comparator / control treatment
No comparator for this feasability study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293370 0
Subjective Wellbeing as measured by the Personal Wellbeing Index (PWI). This is a ten item valid and reliable measure. PArticipants are asked "Thinking about your own life and personal circumstances, please circle the number that best represents how satisfied you feel with your life"
1. Your life as a whole?
2. Your standard of living?
3. Your health?
4. What you are currently achieving in life?
5. Your personal relationships?
6. How safe you feel?
7. Feeling part of your community?
8. Your future security?
9. Your spirituality or religion?
Scale = 0 – 10.
Anchors: 0 – “Not at all satisfied”; 10 – “Completely satisfied”
Timepoint [1] 293370 0
T1 is after 12 sessions of laughter yoga (4 weeks). Participants are asked to complete the T1 PWI following the final Laughter Yoga session.
Secondary outcome [1] 310878 0
Lung Funtion (FEV)
Timepoint [1] 310878 0
At exactly 28 days (4 weeks) following the final session PWI and Lung function measurements are taken. This is to measure any residual effects of the laughter yoga intervention.

Eligibility
Key inclusion criteria
Haemodialysis patient
Monash Health
Consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to communicate in English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Fully informed signed consent following education session
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
This first study is a feasibility study. Descriptive and inferential statistics, and sample size estimates will be calculated using G*Power following this feasibility study.

The number of particpants (n=18) in the feasibility study will be a convenience sample from one dialysis clinic.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2013
Actual
1/10/2013
Date of last participant enrolment
Anticipated
14/10/2013
Actual
14/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 8820 0
3169 - Clayton South

Funding & Sponsors
Funding source category [1] 290097 0
Charities/Societies/Foundations
Name [1] 290097 0
Renal Society of Australasia
Country [1] 290097 0
Australia
Primary sponsor type
Individual
Name
A/Prof Paul Bennett
Address
Center for Nursing Research
Level 2 I Block
Monash Medical Centre
246 Clayton Rd
Clayton VIC, 3169
Country
Australia
Secondary sponsor category [1] 288803 0
None
Name [1] 288803 0
Address [1] 288803 0
Country [1] 288803 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291805 0
Monash Health
Ethics committee address [1] 291805 0
Ethics committee country [1] 291805 0
Australia
Date submitted for ethics approval [1] 291805 0
Approval date [1] 291805 0
27/09/2013
Ethics approval number [1] 291805 0
13287B

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52098 0
Prof Paul Bennett
Address 52098 0
School of Nursing and Midwifey
Deakin University
221 Burwood Highway
Burwood Victoria 3125
Country 52098 0
Australia
Phone 52098 0
+61 3 92517847
Fax 52098 0
Email 52098 0
[email protected]
Contact person for public queries
Name 52099 0
Paul Bennett
Address 52099 0
School of Nursing and Midwifey
Deakin University
221 Burwood Highway
Burwood Victoria 3125
Country 52099 0
Australia
Phone 52099 0
+61 3 92517847
Fax 52099 0
Email 52099 0
[email protected]
Contact person for scientific queries
Name 52100 0
Paul Bennett
Address 52100 0
School of Nursing and Midwifey
Deakin University
221 Burwood Highway
Burwood Victoria 3125
Country 52100 0
Australia
Phone 52100 0
+61 3 92517847
Fax 52100 0
Email 52100 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIntradialytic Laughter Yoga therapy for haemodialysis patients: A pre-post intervention feasibility study.2015https://dx.doi.org/10.1186/s12906-015-0705-5
N.B. These documents automatically identified may not have been verified by the study sponsor.