The Effect of Mirror Education for Women Undergoing Mastectomy

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642628
• Other study ID #: 17006
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: March 28, 2014
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Hypothesis

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Emotional Distress

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Hermann Healthcare System	Houston	Texas
United States	Texas Woman's University	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Texas Woman's University	M.D. Anderson Cancer Center, Memorial Hermann Health System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Freysteinson WM, Deutsch AS, Lewis C, Sisk A, Wuest L, Cesario SK. The experience of viewing oneself in the mirror after a mastectomy. Oncol Nurs Forum. 2012 Jul;39(4):361-9. doi: 10.1188/12.ONF.361-369. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional well-being	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.	Change from pre-operative baseline up to three weeks post-operatively	No
Secondary	Body image	Body image will be measured using the Body Image Scale (BIS).	Change from pre-operative baseline up to three weeks post-operatively	No
Secondary	Anxiety	Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS).	Change from pre-operative baseline up to three weeks post-operatively	No
Secondary	Depression	Depression will be measured using the HADS.	Change from pre-operative baseline up to three weeks post-operatively	No
Secondary	Use of mirrors	Use of mirrors will be measured using a structured questionnaire.	Up to three weeks post-operatively	No