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The Effect of Pre-Operative Education and Self-Reflection on Anxiety, Body Image, Depression and Emotional Well-Being of Women Undergoing Mastectomy


N/A
18 Years
N/A
Open (Enrolling)
Female
Emotional Distress, Anxiety, Depression

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Trial Information

The Effect of Pre-Operative Education and Self-Reflection on Anxiety, Body Image, Depression and Emotional Well-Being of Women Undergoing Mastectomy


The literature suggests women view the mastectomy site in a mirror post-operatively because
they 1) are curious as to what their changed body looks like 2) need to do wound care and 3)
want to keep up personal appearances. Regardless of the reason a women may choose to view
self, viewing the post-operative site may be emotionally difficult. To confound the issue,
the literature also suggests that there are few mirrors available in hospitals, clinics and
physician offices. As such, women who have had a mastectomy may be unable to choose to view
self in a mirror at any time, including during initial and/or subsequent dressing changes,
with the support of a health care professional. The word mirror is seldom if ever discussed,
and mirrors are seldom, if ever, offered to women who have had a mastectomy.

As such, 20 women will be recruited (ten in each group)by ONNs. ONNs will give potential
participants the standardized description of the study and obtain consent. After participant
randomization to either interventional or control groups, ONNs will give participants in the
research group a handheld mirror and a handout on mirrors and mirror viewing. ONN's will
review each element of the handout with the participants. ONN's will provide emotional
support as appropriate for any participant who may have concerns, fears, or questions
concerning the mirror. ONNs will also proceed with usual pre-operative education.

Participants in the control group will receive usual pre-operative education. Usual
pre-operative education consists of a face-to-face pre-operative appointment with the ONN.
The ONN provides education about the upcoming surgery, post-operative procedures, and breast
cancer support resources.

Participants will be phoned post-operatively to set up a meeting one to three weeks
post-operatively to re-administer the written instruments and, in addition, administer a
written structured questionnaire on the subjects' use of the mirror.


Inclusion Criteria:



- Scheduled for breast cancer surgery

- Surgery to result in mastectomy where at least one entire breast is removed

- Speak, read, and understand English

Exclusion Criteria:

- Patients having a guardian that is responsible for medical decisions.

- Patients reporting a diagnosis of body dysmorphic disorder

- Patients who have undergone previous breast cancer surgery

- Patients undergoing breast reconstruction other than placement of implant(s)or tissue
expander(s).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Emotional well-being

Outcome Description:

Emotional well-being will be measured using MOS 36-Item Short Form Survey (SF-36) emotional well-being subscale and Functional Assessment of Cancer Therapies (FACT) emotional well-being scale.

Outcome Time Frame:

Change from pre-operative baseline up to three weeks post-operatively

Safety Issue:

No

Principal Investigator

Wyona M. Freysteinson, PhD, MN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Texas Woman's University

Authority:

United States: Institutional Review Board

Study ID:

17006

NCT ID:

NCT01642628

Start Date:

August 2012

Completion Date:

December 2013

Related Keywords:

  • Emotional Distress
  • Anxiety
  • Depression
  • Mirror
  • Body Image
  • Mastectomy
  • Anxiety Disorders
  • Depression
  • Depressive Disorder

Name

Location

Texas Woman's University Houston, Texas  77030
Memorial Hermann Healthcare System Houston, Texas  77024