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

January 12, 2011
October 31, 2011
April 2010
July 2011   (final data collection date for primary outcome measure)
Stress [ Time Frame: 20 months ] [ Designated as safety issue: No ]
Saliva α-amylase and saliva cortisol
Same as current
Complete list of historical versions of study NCT01275872 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Prostate Cancer
Other: Guided Imagery and Progressive Muscle Relaxation
4 supervised sessions per patient for 4 weeks additional to daily unsupervised sessions
Experimental: Guided Imagery and Progressive Muscle Relaxation
Intervention: Other: Guided Imagery and Progressive Muscle Relaxation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
October 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 72 Years
No
Contact information is only displayed when the study is recruiting subjects
Cyprus
 
NCT01275872
AC-GIPMR-85
Yes
Dr. Andreas Charalambous, Cyprus University of Technology
Cyprus University of Technology
Not Provided
Principal Investigator: Andreas I Charalambous, PhD Cyprus University of Technology
Cyprus University of Technology
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP