Psychosocial Intervention Program for Hysterectomy

子宫切除术的心理社会干预计划

• 批准号: 6697324
• 负责人: ALISON A CALDWELL-ANDREWS
• 金额: $ 8.18万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-01-15 至 2005-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6697324
• 关键词: actigraphy; age difference; anxiety; behavioral /social science research tag; clinical research; cognitive behavior therapy; female; human middle age (35-64); human subject; human therapy evaluation; hysterectomy; outcomes research; patient oriented research; postoperative state; preoperative state; sleep; social support network; socioeconomics; women' s health; young adult human (21-34)

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）：在手术准备领域进行的许多研究评论得出的结论是，手术的心理准备可以改善术后康复。 尽管一些研究涉及进行子宫切除术的患者，并且有针对子宫切除术患者的现有基于信息的程序，但目前尚无经验验证的心理准备计划，专门为接受子宫切除术的女性设计。这项研究的目的是完善针对接受子宫切除术的妇女已经发达的认知行为准备计划，并在降低术前焦虑的能力方面评估该计划的疗效。 我们的研究小组制定了针对接受子宫切除术的妇女的手动和心理准备计划。试点研究数据表明，有一些证据表明该计划是有效的。 我们的研究小组在这项试点研究中的经验以及准备计划将有助于简化用于评估这种干预措施的干预措施和方法，以更强大而彻底的研究。 这项研究完成后，如果已证明“心理准备计划可靠地减少接受子宫切除术的妇女的术前焦虑症”，该计划将被用作较大研究的一部分（不是这项小型赠款应用的一部分），该研究对术前焦虑及其对各种重要的生理和心理术后恢复的影响降低，这将被用作研究的一部分。 因此，这种小赠款应用的主要目的是评估该心理准备计划对接受子宫切除术对术前焦虑的妇女的影响。拟议的研究设计是一项随机对照试验（2条通过2个评估间隙析因设计）检查了两个条件：接受心理准备计划的妇女（PPP组）和接受标准护理（SC组）的妇女。在这项拟议的研究中，计划在耶鲁 - 新避风港医院接受子宫切除术的158名妇女将分配给PPP或SC组。参与者将年满20至60岁，身体健康。 两组将在操作前2-3周完成一份基线问卷数据包，以测量状态焦虑。心理准备计划将在手术前一周进行，两组妇女将在手术前一天晚上完成衡量自己的状态焦虑，并在手术前一天晚上通过Actraphy进行睡眠评估。 这项研究的主要终点是手术前一天晚上患者的状态焦虑。 次要终点是手术前一天晚上患者的睡眠质量。我们假设PPP组的女性在手术前一天晚上比SC组的女性患有更低的状态焦虑和更高的睡眠质量。 将使用重复的协方差分析对数据进行分析。