Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000989549
Ethics application status
Approved
Date submitted
10/09/2015
Date registered
22/09/2015
Date last updated
10/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The SIESTA trial - a randomized Study Investigating the Efficacy, Safety and Tolerability of Acupressure versus sham therapy for improving sleep quality in patients with end-stage kidney disease on haemodialysis
Scientific title
The effects of acupressure therapy vs. sham acupressure therapy for improving sleep quality in patients with end-stage kidney disease on haemodialysis
Secondary ID [1] 287438 0
Nil
Universal Trial Number (UTN)
U1111-1174-2313
Trial acronym
SIESTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep problem with patients on maintenance haemodialysis 296153 0
end-stage kidney disease 296229 0
Condition category
Condition code
Alternative and Complementary Medicine 296436 296436 0 0
Other alternative and complementary medicine
Renal and Urogenital 296437 296437 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the experimental group will receive acupressure therapy on Shen Men (HT7) and Yongquan (K11). The acupressure therapy will be delivered thrice weekly for four consecutive weeks during their routine HD/HDF sessions. The therapy time at each acupoint will last for 3 minutes each and the applied intensity will depend on the patient’s individual tolerance level.
Intervention code [1] 292810 0
Treatment: Other
Comparator / control treatment
Participants in the control group will receive sham acupressure therapy on a non-specific acupoint-Zhongquan (EX-EU3) and a sham acupoint (S). The sham acupressure therapy will be delivered thrice weekly for four consecutive weeks during their routine HD/HDF sessions. The therapy time at each acupoint will last for 3 minutes each and the applied intensity will depend on the patient’s individual tolerance level.
Control group
Placebo

Outcomes
Primary outcome [1] 296057 0
The primary objective of the Study is to determine whether the acupressure therapy delivered over 4 weeks during thrice weekly HD/HDF sessions can decrease the Pittsburgh Sleep Quality Index (PSQI) scores.
Timepoint [1] 296057 0
4 weeks after commencement of intervention
Secondary outcome [1] 317390 0
Patient acceptability assessed using visual analogue scale (VAS) questionnaire
Timepoint [1] 317390 0
4 weeks after commencement of intervention
Secondary outcome [2] 317565 0
Quality of life assessed using (Short Form)-8 Health Survery
Timepoint [2] 317565 0
4 weeks after commencement of intervention
Secondary outcome [3] 317568 0
Side effects (i.e, the local skin reaction from acupressure) will be recorded in Form AE (adverse event).
Timepoint [3] 317568 0
Any time during the 4 week therapy period

Eligibility
Key inclusion criteria
Participants must meet ALL of the following inclusion criteria:
1. On maintenance HD for at least 3 months,
2. 3 HD/HDF sessions per week
3. Aged over 18 years
4. No plans to change mode of renal replacement therapy within the study period (4 weeks)
5. Able to provide informed consent
6. Able to complete patient questionnaire in English independently
7. Self-reported history of poor sleep quality
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must not meet ANY of the following exclusion criteria:
1. History of amputation
2. Serious skin problems (e.g. dermatitis) near the location of the acupoints
3. Has background knowledge of Traditional Chinese medicine (TCM)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Block randomisation with blocks of eight will be used to allocate patients to treatment. Patients will be allocated to treatment in a 1:1 ratio. Therefore, within each group of eight, four will be allocated to the intervention and four to the placebo.

Allocation concealment will be achieved by utilising a sealed opaque envelope and randomisation sequence will be generated by an independent researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be generated by an independent researcher and each random number will be kept in a sealed opaque envelope.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Single-blind trial where participants will not be aware whether they are receiving acupressure treatments at 'real' or 'sham' acupoints. This information will only be known to the therapist delivering therapy who will not disclose this information to the participants or other study investigators or outcome assessors.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. STATA (version 14.0) will be used for data entry and analyses. Results will be expressed as frequencies and percentages for categorical variables, mean±standard deviation for continuous normally distributed variables, and median with interquartile range for continuous non-normally distributed variables. Repeated measures ANCOVA will be used to examine the differences in the change in PSQI scores between the treatment and control groups. P values of <0.05 will be considered to represent a statistically significant result.

2. The SIESTA study is a pilot study to examine the efficacy and acceptability of acupressure as a therapy in HD/HDF patients in Australia. As such, no formal sample size calculation has been conducted. The study aims to recruit 40 patients to help achieve its objectives.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2015
Actual
23/09/2015
Date of last participant enrolment
Anticipated
Actual
2/12/2015
Date of last data collection
Anticipated
Actual
6/01/2016
Sample size
Target
40
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4328 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 5061 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 10473 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 12547 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 292013 0
Self funded/Unfunded
Name [1] 292013 0
Country [1] 292013 0
Primary sponsor type
Individual
Name
David Johnson
Address
ARTS Building Princess Alexandra Hospital
199 Ipswich Road Woolloongabba Qld 4102
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 290682 0
Individual
Name [1] 290682 0
Xusheng Liu
Address [1] 290682 0
Guangdong Provincial Hospital of Chinese Medicine, No 111 Dade Road, Yuexiu district, Guangzhou, 510120, China
Country [1] 290682 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293502 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 293502 0
Ethics committee country [1] 293502 0
Australia
Date submitted for ethics approval [1] 293502 0
15/07/2015
Approval date [1] 293502 0
27/08/2015
Ethics approval number [1] 293502 0
HREC/15/QPAH/455

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 712 712 0 0
/AnzctrAttachments/369278-SKMBT_C452 15101408520.pdf
Attachments [2] 713 713 0 0
/AnzctrAttachments/369278-ssa-15-460 Approved Ltr.pdf

Contacts
Principal investigator
Name 60170 0
Prof David Johnson
Address 60170 0
Level 2 ARTS Building, Department of Nephrology, Princess Alexandra Hospital, Woolloongabba Qld Australia 4102
Country 60170 0
Australia
Phone 60170 0
+61731765080
Fax 60170 0
+61731765480
Email 60170 0
[email protected]
Contact person for public queries
Name 60171 0
Yeoungee Cho
Address 60171 0
Level 2 ARTS Building, Department of Nephrology, Princess Alexandra Hospital, Woolloongabba Qld Australia 4102
Country 60171 0
Australia
Phone 60171 0
+61731765080
Fax 60171 0
Email 60171 0
[email protected]
Contact person for scientific queries
Name 60172 0
Kunyu Shen
Address 60172 0
Level 5 Translational research institute, 37 Kent Street, Woolloongabba Qld Australia 4102
Country 60172 0
Australia
Phone 60172 0
+610401648510
Fax 60172 0
Email 60172 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
EmbaseThe SIESTA trial: A randomized study investigating the efficacy, safety, and tolerability of acupressure versus sham therapy for improving sleep quality in patients with end-stage kidney disease on hemodialysis.2017https://dx.doi.org/10.1155/2017/7570352
N.B. These documents automatically identified may not have been verified by the study sponsor.