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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2024-05-10

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain Syndrome Pain Symptom Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group 1 (The Intervention Group)

Participants will receive guided imagery and deep breathing technique exercises.

Group Type EXPERIMENTAL

The Intervention Group

Intervention Type OTHER

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.

Group 2 ( The Control Group)

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

Group Type EXPERIMENTAL

The Control Group

Intervention Type OTHER

Participants will continue to receive your current care, but will not receive guided imagery or deep breathing exercises from a social worker.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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