Many reviews of research in the area of preparation for surgery have concluded that psychological preparation for surgery results in an improved postoperative recovery. Although some studies have involved patients undergoing hysterectomy, and there are existing information-based programs specific to hysterectomy patients, at this time there are no empirically validated psychological preparation programs specifically designed for women undergoing hysterectomy. The goal of this study is to refine an already-developed cognitive-behavioral preparation program for women undergoing hysterectomy, and to evaluate the efficacy of this program in terms of its ability to lower preoperative anxiety. ? ? A manual and psychological preparation program for women undergoing hysterectomy has been developed by our study group. Pilot study data suggests that there is some evidence that this program is an effective one. Our study group's experience with this pilot study and the preparation program will help inform refinement of the intervention and methods for evaluating this intervention in a more powerful and thorough study. After this investigation is completed and if the psychological preparation program has been shown to reliably reduce preoperative anxiety in women undergoing hysterectomy, this program will be used as part of a larger study (not a part of this small grant application) which wilt examine reduction of preoperative anxiety and its impact on various important physiological and psychological postoperative recovery outcomes. ? ? The primary aim, therefore, of this small grant application is to evaluate the effects of this psychological preparation program for women undergoing hysterectomy on preoperative anxiety. The proposed study design is a randomized controlled trial (2 condition by 2 assessment-interval factorial design) examining two conditions: women who receive the psychological preparation program (PPP group) and women who receive preparation that is standard of care (SC group). In this proposed study, 158 women scheduled to undergo hysterectomy at Yale-New Haven Hospital will be assigned to the PPP or SC group. Participants will be 20-60 years of age and in good health. Both groups will complete a baseline questionnaire packet measuring state anxiety 2-3 weeks prior to their operation. The psychological preparation program will be administered one week before surgery, and both groups of women will complete a measure of their state anxiety on the evening before surgery, and undergo sleep assessment via actigraphy on the night before surgery. The primary endpoint of this study is patient's state anxiety the evening before surgery. The secondary endpoint is the patient's quality of sleep the night before surgery. We hypothesize that women in the PPP group will have lower state anxiety and higher quality of sleep the evening before surgery than women in the SC group. Data will be analyzed using repeated measures analysis of covariance. ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Small Research Grants (R03)
Project #
5R03MH067196-02
Application #
6697324
Study Section
Special Emphasis Panel (ZRG1-SSS-N (02))
Program Officer
Muehrer, Peter R
Project Start
2003-01-15
Project End
2005-12-31
Budget Start
2004-01-01
Budget End
2005-12-31
Support Year
2
Fiscal Year
2004
Total Cost
$81,750
Indirect Cost
Name
Yale University
Department
Anesthesiology
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520