search
Back to results

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

Primary Purpose

Sleep Disturbance, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Therapeutic massage
Sham massage
Sponsored by
Cyprus University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Oncology Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Therapeutic massage

Sham massage

Arm Description

Women will undertake sessions of therapeutic massage

Women will undertake sessions of sham massage

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
January 9, 2018
Last Updated
January 30, 2019
Sponsor
Cyprus University of Technology
Collaborators
Cyprus Anticancer Society
search

1. Study Identification

Unique Protocol Identification Number
NCT03415230
Brief Title
Effect of Therapeutic Massage on Sleep Quality and Stress Levels in Women With Breast Cancer
Official Title
Effect of Therapeutic Massage on Sleep Quality and Stress Levels in Women With Breast Cancer: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
January 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cyprus University of Technology
Collaborators
Cyprus Anticancer Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
therapeutic massage vs sham massage
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic massage
Arm Type
Experimental
Arm Description
Women will undertake sessions of therapeutic massage
Arm Title
Sham massage
Arm Type
Sham Comparator
Arm Description
Women will undertake sessions of sham massage
Intervention Type
Other
Intervention Name(s)
Therapeutic massage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham massage
Intervention Description
Sham massage involves only light touch massage in a non systematic way
Primary Outcome Measure Information:
Title
Sleep Disturbances (insomnia)
Description
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
Secondary Outcome Measure Information:
Title
Anxiety
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with Breast Cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Charalambous, PhD
Organizational Affiliation
Cyprus University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology Centre
City
Nicosia
ZIP/Postal Code
2006
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Demographic information can be shared

Learn more about this trial

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

We'll reach out to this number within 24 hrs