An interventional study of Therapeutic massage and Sham massage in Sleep Disturbance and Anxiety, sponsored by Cyprus University of Technology. Completed at 1 site in Cyprus. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-01-31.
Sponsored by Cyprus University of Technology · Not applicable, Interventional, and Treatment
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This is a randomized control trial to test the effectiveness of therapeutic massage on the sleep quality and the stress levels in women that have completed their treatment for breast cancer.
The period following the completion of treatment for breast cancer (but also for any other type of cancer as well) is once that is accompanied by an increased uncertainty. This can often trigger increased anxiety levels and sleep disturbances. This trial tests the effectiveness of therapeutic massage as a non pharmaceutical intervention that can increase the management of stress and sleep disturbances during this period of time.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Cyprus University of Technology is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Women will undertake sessions of therapeutic massage
Other: Therapeutic massage
Women will undertake sessions of sham massage
Other: Sham massage
Massage therapy involves the administration of combinations of specific physical manipulations applied in a systematic way, with varying intensity, direction, rate, and rhythm, to the soft tissues of the body.
Sham massage involves only light touch massage in a non systematic way
Sleep Disturbances (insomnia)
Athens insomnia scale (The AIS is a self-assessment psychometric instrument designed for quantifying sleep difficulty based on the ICD-10 criteria. It consists of eight items: the first five pertain to sleep induction, awakenings during the night, final awakening, total sleep duration, and sleep quality; while the last three refer to well-being, functioning capacity, and sleepiness during the day). Each item of the AIS can be rated 0-3, (with 0 corresponding to no problem at all and 3 to very serious problem); thus, the total score ranges from 0 (absence of any sleep-related problem) to 24 (the most severe degree of insomnia).
Time frame: Change from baseline total score at 4 weeks
Anxiety
Hamilton Anxiety Rating Scale (HAM-A). The scale consists of 14 items. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time frame: Change from baseline total score at 4 weeks
Plan to share: Undecided — Demographic information can be shared
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Dec 2018, 8 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 8 months is below that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Cyprus University of Technology