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

October 31, 2011 updated by: Dr. Andreas Charalambous, Cyprus University of Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Nicosia, Cyprus, 2006
        • Bank Of Cyprus Oncology Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: 20 months
Saliva α-amylase and saliva cortisol
20 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: 20 months
20 months
Fatigue
Time Frame: 20 months
20 months
Anxiety
Time Frame: 20 months
20 months
Depression
Time Frame: 20 months
20 months
Nausea-vomit
Time Frame: 20 months
20 months
Pain
Time Frame: 20 months
20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyprus University of Technology

Investigators

  • Principal Investigator: Andreas I Charalambous, PhD, Cyprus University of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 12, 2011

First Submitted That Met QC Criteria

January 12, 2011

First Posted (Estimate)

January 13, 2011

Study Record Updates

Last Update Posted (Estimate)

November 1, 2011

Last Update Submitted That Met QC Criteria

October 31, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-GIPMR-85

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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