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The Effect of Mirror Education for Women Undergoing Mastectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01642628
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : April 1, 2014
Memorial Hermann Health System
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Wyona M. Freysteinson, PhD, MN, Texas Woman's University

Brief Summary:

Intuitively, the investigators surmise the initial and subsequent viewing of a breast site following mastectomy may be traumatic. A qualitative study on the experience of viewing self in the mirror for a woman who has had a mastectomy has confirmed the experience is unique for each individual, and may well be difficult. This research study aims to determine if these difficult moments may be buffered by a mirror intervention providing women who are scheduled for a mastectomy with a hand held mirror, instructions by a Oncology Nurse Navigator (ONN) on how to use the mirror in initial and subsequent dressing changes, and offering to discuss any concerns or questions.

The purpose of this study is to evaluate the feasibility of a nursing mirror educational intervention and determine if it is of potential value for women scheduled for a mastectomy. Results from this pilot study will help determine whether the research design, setting, sample, instruments, data collection and data analysis are appropriate and practical for a larger study.


Women, ages 18 and over, who have had a mastectomy, and receive a planned pre-operative education and self-reflection intervention will have relatively improved anxiety, body image, depression and emotional well-being scores one to three weeks post-operatively as compared to those who received usual care.

Condition or disease Intervention/treatment Phase
Emotional Distress Anxiety Depression Other: Mirror Education Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Pre-Operative Education and Self-Reflection on Anxiety, Body Image, Depression and Emotional Well-Being of Women Undergoing Mastectomy
Study Start Date : August 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Mastectomy

Arm Intervention/treatment
Experimental: Body Image/Mirror Education
Participants in the mirror arm will receive a mirror and mirror viewing education from oncology nurse navigators.
Other: Mirror Education
Patients allocated to the experimental group will be given a small hand-held mirror and structured mirror viewing education verbally. In addition, they will receive a mirror viewing handout. This intervention will be given prior to mastectomy surgery. In addition, participants will receive all other standard care.
Other Name: Experimental group

No Intervention: Standard Care
Patients allocated to the control group will receive the usual pre and post-op standard care that does not include the use or discussion of mirrors.

Primary Outcome Measures :
  1. Emotional well-being [ Time Frame: Change from pre-operative baseline up to three weeks post-operatively ]
    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.

Secondary Outcome Measures :
  1. Body image [ Time Frame: Change from pre-operative baseline up to three weeks post-operatively ]
    Body image will be measured using the Body Image Scale (BIS).

  2. Anxiety [ Time Frame: Change from pre-operative baseline up to three weeks post-operatively ]
    Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS).

  3. Depression [ Time Frame: Change from pre-operative baseline up to three weeks post-operatively ]
    Depression will be measured using the HADS.

  4. Use of mirrors [ Time Frame: Up to three weeks post-operatively ]
    Use of mirrors will be measured using a structured questionnaire.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01642628

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United States, Texas
Memorial Hermann Healthcare System
Houston, Texas, United States, 77024
Texas Woman's University
Houston, Texas, United States, 77030
Sponsors and Collaborators
Texas Woman's University
Memorial Hermann Health System
M.D. Anderson Cancer Center
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Principal Investigator: Wyona M. Freysteinson, PhD, MN Texas Woman's University
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Responsible Party: Wyona M. Freysteinson, PhD, MN, Assistant Professor, Texas Woman's University Identifier: NCT01642628    
Other Study ID Numbers: 17006
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014
Keywords provided by Wyona M. Freysteinson, PhD, MN, Texas Woman's University:
Body Image
Additional relevant MeSH terms:
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Behavioral Symptoms