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

Not Applicable

Completed

• Conditions: Symptom Management; Pain Syndrome; Pain
• Interventions: Other: The Intervention Group; Other: The Control Group

• Registration Number: NCT05408741
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-02
• Study Start: 2022-06-06
• Study First Posted: 2022-06-07
• Status Verified: 2024-05
• Primary Completion: 2024-05-10
• Study Completion: 2024-05-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Breast Cancer patients who were performed mastectomy in previous 12 months
2. Post-mastectomy pain syndrome >4 weeks.
3. Patients who report 2-10 on the baseline pain severity score or 2-10 on the baseline pain interference score
4. Patients ≥ 18 years old and ≤ 70 years old
5. Must understand and read English, sign a written informed consent, and follow protocol requirements
6. 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

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Exclusion Criteria

1. Pending surgery during treatment
2. Suicidal ideation
3. Diagnosis of a formal thought disorder (e.g., schizophrenia)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1 (The Intervention Group)	The Intervention Group	Participants will receive guided imagery and deep breathing technique exercises.
Group 2 ( The Control Group)	The Control Group	Participants will not receive any relaxation techniques. Participants will receive the current standard of care.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States