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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408741
• Other study ID #: 2020-1104
• Secondary ID: NCI-2022-04827
• Status: Completed
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: May 10, 2024

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 10, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain
• Pain Syndrome
• Somatoform Disorders
• Symptom Management
• Syndrome

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   MD Anderson Cancer Center