The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema
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|ClinicalTrials.gov Identifier: NCT02650297|
Recruitment Status : Completed
First Posted : January 8, 2016
Last Update Posted : January 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lymphedema||Other: combined decongestive therapy Device: pneumatic compression pump||Phase 1 Phase 2|
Lymphedema is a common complication for breast cancer therapy. Patients with lymphedema may experience pain and body image issues. This study investigates the effect of Combined Decongestive Therapy and pneumatic compression pump on body image in patients with lymphedema secondary to breast cancer treatment.
methods: 42 women with breast cancer related lymphedema participated. All patients completed the body image and relationships scale. Researchers divided the participants randomly into an intervention (n=21) or control group (n=21). A certified nurse worked on Combined Decongestive Therapy in the intervention group in two phases. In the first phase, CDT was accompanied by use of a compression pump for four weeks, three days per week. In the second phase, CDT was performed daily without compression pump for four weeks by patients at home. At the end of each phase, both groups completed the questionaire. Researchers analyzed the data with SPSS v.17.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema Secondary to Breast Cancer Treatment|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||December 2009|
Experimental: CDT and pneumatic compression pump
combined decongestive therapy consists of the pressure of bandage, manual lymphatic drainage, and exercises that increase the flow of lymph and skin care are used. Intermittent pneumatic pump is not as a part of CDT, but it can be used as an adjunct method. This device according to a specific program is air filled and emptied. The device leads the lymphatic fluid from distal to the proximal part of extremities and then to the trunk.
Other: combined decongestive therapy
Patients in the intervention group received treatment with combined decongestive therapy and pneumatic compression pump. Patients in the control group received no treatment for lymphedema but were placed on the waiting list for combined decongestive therapy and pneumatic compression pump as soon as possible after the 8 weeks follow-up period.
Device: pneumatic compression pump
Intermittent pneumatic pump or pressure therapy is not as a part of CDT, but it can be used as an adjunct method. This device intermittently and according to a specific program is air filled and emptied. The device leads the lymphatic fluid from distal to the proximal part of extremities and then to the trunk
No Intervention: not CDT and pneumatic compression pump
Patients in the control group received no treatment for lymphedema but were placed on the waiting list for CDT as soon as possible after the 8 weeks follow-up period.
- changes in the body image [ Time Frame: change from baseline body image at 8 weeks ]Body image evaluated with the body image and relationships scale. Body image and relationships scale is a questionnaire that consists of 32 items in the three subscales or factors, named strength and health, social barriers, and appearance and sexuality. Higher scores on each subscale indicated greater impairment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650297
|Study Chair:||badri jaafari, author||Department of Nursing, College of Nursing & Midwifery, Kazeroun Azad University, Kazeroun, Iran|