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Completed

NCT Number: NCT03415230

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

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.

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Key information

Conditions

Sleep Disturbance Anxiety Anxiety Disorders Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oncology Centre

Nicosia, 2006, Cyprus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic Massage

Other

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

Other

Sham massage involves only light touch massage in a non systematic way

Primary outcomes

  1. Sleep Disturbances (insomnia)

    Time frame: 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 outcomes

  1. Anxiety

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cyprus University of Technology

Other

Collaborators

  • Cyprus Anticancer Society

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 30, 2018
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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