Effect of Therapeutic Massage on Sleep Quality and Stress Levels in Women With Breast Cancer

Not Applicable

Completed

• Conditions: Sleep Disturbance; Anxiety
• Interventions: Other: Therapeutic massage; Other: Sham massage

• Registration Number: NCT03415230
• Lead Sponsor: Cyprus University of Technology

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.

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-30
• Study Start: 2018-04-01
• Primary Completion: 2018-12-20
• Status Verified: 2019-01
• Study Completion: 2019-01-09
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic massage	Therapeutic massage	Women will undertake sessions of therapeutic massage
Sham massage	Sham massage	Women will undertake sessions of sham massage

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Oncology Centre; 🇨🇾 Nicosia, Cyprus