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OpenTrials
Completed

NCT Number: NCT05408741

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MD Anderson Cancer Center

Houston, Texas, 77051, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

The intervention group

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.

The control group

Other

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

Primary outcomes

  1. 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

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2022
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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