跳至主要内容
临床试验/NCT04822493
NCT04822493已完成不适用

Improving Pain Perceptions After Initiating a Delivery Application

Prisma Health-Upstate1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
Patient satisfaction as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R).

研究概览

简要总结

The investigators of this study have developed a standardized counseling aid using an electronic mobile device to help women learn about what to expect during labor and subsequent vaginal delivery or cesarean delivery, specifically regarding pain expectations. Half of women will complete the counseling aid and the other half will receive standard counseling and care. The study aims to determine if the counseling aid improves patient satisfaction and perception of pain control.

详细描述

A. Objective To compare perception of postpartum pain and patient satisfaction between women who receive routine obstetric care to those who receive routine obstetric care and complete a standardized counseling aid antepartum.

B. Background Enhanced Recovery After Surgery (ERAS) is a standardized, evidenced-based method for the perioperative management of surgical patients. ERAS protocols have been well studied in several surgical specialties, including gynecologic oncology and benign gynecology, and have been shown to reduce hospital length of stay and costs without increasing rates of complications or readmission.

The use of ERAS in obstetrics is also growing. Recent studies have shown that an enhanced recovery pathway after cesarean delivery can decrease hospital stay and cost and reduce opioid use. Guidelines have been developed for evidence-based recommendations for preoperative, intraoperative and postoperative phases of care.

An important component of any ERAS protocol is pre-operative counseling. Postoperative pain management starts with counseling prior to surgery. Guidelines suggest that preoperative counseling should include patient-centered education on the options for management of pain. This process also allows an opportunity to engage patients in the decision making process. Previous studies have shown that counseling on pain expectations can improve patient outcomes.

The aim of our study is to develop a standardized antepartum counseling aid and improve postpartum pain perceptions and patient experience.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Pregnant women > 18 years of age
  • •Gestational age 35 weeks to 41 weeks
  • •English or Spanish speaking
  • •Plan for vaginal delivery or cesarean delivery at Greenville Memorial Hospital
  • •Singleton or twin gestation

排除标准

  • •Non-English or Non-Spanish speaking patients
  • •Inability to read English, inability to read Spanish
  • •Pregnancy diagnosed with fetal anomalies
  • •Intrauterine fetal demise

研究组 & 干预措施

Counseling Aid

Experimental

A. Complete the demographic questionnaire, the survey questions, and then complete the counseling aid. Receive standard counseling as part of routine prenatal care.

B. Prior to discharge after delivery, study personnel will administer the postpartum questionnaire via a mobile tablet. The questionnaire is programmed into the study application.

干预措施: Counseling Aid (Other)

Standard Care

No Intervention

A. Complete the demographic questionnaire and survey questions without watching the educational video. Receive standard counseling as part of routine prenatal care.

B. Prior to discharge after delivery, study personnel will administer the postpartum questionnaire via a mobile tablet. The questionnaire is programmed into the study application.

结局指标

主要结局

Patient satisfaction as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R).

时间窗: 1 year

What is the impact of a standardized antepartum counseling aid on patient satisfaction with pain expectation counseling during hospital admission for labor and delivery compared to women who do not use the counseling aid and receive routine counseling only? Satisfaction of pain expectation counseling will be measured using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R). The APS-POQ-R is designed for use in adult hospital pain management QI activities and measures 6 aspects of quality including: (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) helpfulness of information about pain treatment; (5) ability to participate in pain treatment decisions; and (6) use of nonpharmocological strategies. Participants will respond on a scale of 0 to 10. 0 indicating they were extremely dissatisfied and 10 indicating they were extremely satisfied.

次要结局

  • Medication at discharge(1 year)
  • Effects of pain on recovery(1 year)
  • Narcotic use(1 year)
  • Pain and mood(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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