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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Symptom Management; Pain Syndrome; Pain

Treatments: Other: The Intervention Group; Other: The Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05408741

2020-1104

NCI-2022-04827 (Other Identifier)

Details and patient eligibility

About

To learn if using guided imagery and deep breathing techniques can help with pain management in patients who have post-mastectomy pain syndrome.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Group 1 (The Intervention Group)

Experimental group

Description:

Participants will receive guided imagery and deep breathing technique exercises.

Treatment:

Other: The Intervention Group

Group 2 ( The Control Group)

Experimental group

Description:

Participants will not receive any relaxation techniques. Participants will receive the current standard of care.

Treatment:

Other: The Control Group