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

Anxiety Clinical Trial

Official title:

Effect of Therapeutic Massage on Sleep Quality and Stress Levels in Women With Breast Cancer: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03415230
• Other study ID #: AC-TMSQ-2018
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: January 9, 2019

Study information

• Verified date: January 2019
• Source: Cyprus University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 9, 2019
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Other:
• Therapeutic 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
Sham massage involves only light touch massage in a non systematic way

Locations

Country	Name	City	State
Cyprus	Oncology Centre	Nicosia

Sponsors (2)

Lead Sponsor	Collaborator
Cyprus University of Technology	Cyprus Anticancer Society

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline total score at 4 weeks
Secondary	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.	Change from baseline total score at 4 weeks