A Pilot Study Assessing the Effectiveness of Use of Guided Imagery for Treatment of Pain and Symptom Management in Women With Post-mastectomy Pain Syndrome
Study Details
Study Description
Brief Summary
To learn if using guided imagery and deep breathing techniques can help with pain management in patients who have post-mastectomy pain syndrome.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
OBJECTIVES:
Primary objective:
-To evaluate the effectiveness of use of Guided imagery and deep breathing techniques in pain management compared to control arm in patients with post-mastectomy pain syndrome who don't receive intervention and only receive standard care.
Secondary objective:
To evaluate effectiveness of Guided imagery and deep breathing techniques in symptom cluster management including fatigue, sleep, depression, and anxiety and in general quality of life compared to control arm who don't receive intervention and only receive standard care.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 (The Intervention Group) Participants will receive guided imagery and deep breathing technique exercises. |
Other: The Intervention Group
Participants will complete a 20-minute guided imagery exercise (which includes deep breathing exercises) every day at home using the selected app and/or resource you downloaded at the beginning of this study.
|
| Experimental: Group 2 ( The Control Group) Participants will not receive any relaxation techniques. Participants will receive the current standard of care. |
Other: The Control Group
Participants will continue to receive your current care, but will not receive guided imagery or deep breathing exercises from a social worker.
|
Outcome Measures
Primary Outcome Measures
- The change in pain severity score and the change in pain interference score, measured by brief pain inventory short form. Brief Pain Inventory: 0-10 No Pain-0 Worst Pain-10 [through study completion, an average of 1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Breast Cancer patients who were performed mastectomy in previous 12 months
-
Chronic post-mastectomy pain syndrome (≥3 months)
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Patients who report 5-10 on the baseline pain severity score or 5-10 on the baseline pain interference score
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Patients ≥ 18 years old and ≤ 70 years old
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Must understand and read English, sign a written informed consent, and follow protocol requirements
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If on medication for anxiety or depression, stable dose of medications for management of anxiety or depression symptoms for at least six weeks prior to enrollment with no plans to change medications in the subsequent four weeks. Increases or decreases allowed within drug class, but changing drug class will make patient in-evaluable
Exclusion Criteria:
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Current chemotherapy or radiation
-
Pending surgery during treatment
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Other chronic pain diagnosis besides post mastectomy pain syndrome (PMPS)
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Suicidal ideation
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Diagnosis of a formal thought disorder (e.g., schizophrenia)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MD Anderson Cancer Center | Houston | Texas | United States | 77051 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Uzondu Osuagwu, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2020-1104
- NCI-2022-04827