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

Last updated: October 21, 2024
Sponsor: M.D. Anderson Cancer Center
Overall Status: Completed

Phase

N/A

Condition

Pain

Somatoform And Dissociative Disorders

Mood Disorders

Treatment

The Control Group

The Intervention Group

Clinical Study ID

NCT05408741
2020-1104
NCI-2022-04827
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 baselinepain interference score

  4. Patients ≥ 18 years old and ≤ 70 years old

  5. Must understand and read English, sign a written informed consent, and followprotocol requirements

  6. If on medication for anxiety or depression, stable dose of medications formanagement of anxiety or depression symptoms for at least six weeks prior toenrollment with no plans to change medications in the subsequent four weeks.Increases or decreases allowed within drug class, but changing drug class will makepatient in-evaluable

Exclusion

Exclusion Criteria:

  1. Pending surgery during treatment

  2. Suicidal ideation

  3. Diagnosis of a formal thought disorder (e.g., schizophrenia)

Study Design

Total Participants: 9
Treatment Group(s): 2
Primary Treatment: The Control Group
Phase:
Study Start date:
June 06, 2022
Estimated Completion Date:
May 10, 2024

Study 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.

Connect with a study center

  • MD Anderson Cancer Center

    Houston, Texas 77051
    United States

    Site Not Available

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