The clinical trial examines guided imagery and deep breathing techniques in treating pain and symptom management in patients who have post-mastectomy pain syndrome. Guided imagery is a type of visualization exercise that helps patients picture or imagine images in their mind that helps them feel positive, helps focus their thoughts, and helps to calm or relax them, which may reduce feelings of stress and anxiety. Deep breathing exercises, which are typically done with guided imagery exercises, focuses on taking deep, slow, even breaths. This type of breathing may also help to relax patients and increase feelings of well-being. Guided imagery and deep breathing may help to improve general quality of life and manage other symptoms of post-mastectomy pain syndrome, such as fatigue, inability to sleep, depression, anxiety.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05408741.
PRIMARY OBJECTIVE:
I. 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:
I. 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.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive guided imagery and deep breathing technique exercises facilitated by a licensed clinical social worker (LCSW) once a week for 3 weeks on visits 1-3, as well as self-guided imagery via audio over 20 minutes daily.
ARM II: Patients receive current standard of care and meet with a LCSW once a week for 3 weeks on visits 1-3.
After completion of study intervention, patients are followed up at 28 days.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorUzondu Osuagwu