Sleep Disturbance, Anxiety
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERTherapeutic 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.
OTHERSham massage
Sham massage involves only light touch massage in a non systematic way
Sponsors
Cyprus Anticancer Society
Cyprus University of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
therapeutic massage vs sham massage
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Women that completed their treatment * women experiencing insomnia * women experiencing anxiety * women that speak and understand Greek
Exclusion criteria
* allergy to essential oils * use of anticoagulants * presence of edema * presence of Varicose veins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbances (insomnia) | Change from baseline total score at 4 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Change from baseline total score at 4 weeks | 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. |
Countries
Cyprus
Outcome results
None listed