Text Size

Effect of Guided Imagery and Progressive Muscle Relaxation as a Means to Improve the Psychological Well-being and the Quality of Life for Patients With Breast and Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Andreas Charalambous, Cyprus University of Technology
ClinicalTrials.gov Identifier:
NCT01275872
First received: January 12, 2011
Last updated: October 31, 2011
Last verified: October 2011
History of Changes
  Purpose

The purpose of this study is to determine whether Guided Imagery and Progressive Muscle Relaxation techniques are effective in the management of pain, fatigue, nausea-vomit, anxiety and depression in patients with either prostate or breast cancer.

This study includes a total of 200 patients with prostate and breast cancer randomly assigned to either a control or intervention group.

The intervention group received in total 4 sessions of Guided Imagery (protocol floating on a cloud) and Progressive Muscle Relaxation (breathing exercises and use of 11 groups of muscle progressively tensing and relaxing).

Measurements included the assessment of pain, fatigue, nausea-vomit, depression, anxiety and quality of life. Additionally, saliva samples were collected prior and after the sessions as to assess saliva cortisol and saliva α-amylase.

The same measurements were received by the patients of the control group as to allow comparisons.


Condition Intervention
Breast Cancer
Prostate Cancer
 Other: Guided Imagery and Progressive Muscle Relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Clinical Trial on the Effect of Guided Imagery and Progressive Muscle Relaxation for the Management of Pain, Stress, Anxiety and Depression as a Means to Improve the Psychological Well-being and the Quality of Life for Patients With Breast and Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cyprus University of Technology:

Primary Outcome Measures:
  • Stress [ Time Frame: 20 months ] [ Designated as safety issue: No ]
    Saliva α-amylase and saliva cortisol


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Nausea-vomit [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 20 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Guided Imagery and Progressive Muscle Relaxation Other: Guided Imagery and Progressive Muscle Relaxation
4 supervised sessions per patient for 4 weeks additional to daily unsupervised sessions

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of breast or prostate cancer
  • Must be able to follow instructions
  • Good cognitive ability
  • Willing to participate

Exclusion Criteria:

  • Use of cortisone
  • Xerostomia
  • oral mucositis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275872

Locations
Cyprus
Bank of Cyprus Oncology Centre
Nicosia, Cyprus, 2006
Sponsors and Collaborators
Cyprus University of Technology
Investigators
Principal Investigator: Andreas I Charalambous, PhD Cyprus University of Technology
  More Information

No publications provided

Responsible Party: Dr. Andreas Charalambous, Lecturer-Researcher, Cyprus University of Technology
ClinicalTrials.gov Identifier: NCT01275872     History of Changes
Other Study ID Numbers: AC-GIPMR-85
Study First Received: January 12, 2011
Last Updated: October 31, 2011
Health Authority: Cyprus: Cyprus National Bio-Ethics Committee

Keywords provided by Cyprus University of Technology:
guided imagery
progressive muscle relaxation
complimentary and alternative medicine
quality of life
 stress
pain
anxiety

Additional relevant MeSH terms:
Breast Neoplasms
Muscle Hypotonia
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Manifestations
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 18, 2012