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:
Cyprus University of Technology
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
| Tracking Information | |||||
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| First Received Date ICMJE | January 12, 2011 | ||||
| Last Updated Date | October 31, 2011 | ||||
| Start Date ICMJE | April 2010 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Stress [ Time Frame: 20 months ] [ Designated as safety issue: No ] Saliva α-amylase and saliva cortisol |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01275872 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 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 | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Guided Imagery and Progressive Muscle Relaxation
4 supervised sessions per patient for 4 weeks additional to daily unsupervised sessions |
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| Study Arm (s) | Experimental: Guided Imagery and Progressive Muscle Relaxation
Intervention: Other: Guided Imagery and Progressive Muscle Relaxation |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | October 2011 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 72 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Cyprus | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01275872 | ||||
| Other Study ID Numbers ICMJE | AC-GIPMR-85 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Andreas Charalambous, Cyprus University of Technology | ||||
| Study Sponsor ICMJE | Cyprus University of Technology | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Cyprus University of Technology | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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