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临床试验/NCT03227614
NCT03227614已完成不适用

Friends/Family in the Abortion Procedure Room (FAIR): Assessing Pain Level, Patient, Staff and Support Person Satisfaction With Support Person in Abortion Procedure Room: A Randomized Controlled Trial

Planned Parenthood of Southwest and Central Florida2 个研究点 分布在 1 个国家目标入组 422 人开始时间: 2017年7月18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
发起方
入组人数
422
试验地点
2
主要终点
Anxiety

研究概览

简要总结

This study aims to explore patient, support person, and health care providers' experience and satisfaction with social support in the abortion procedure room. Although some providers do allow a support person in the abortion procedure room, no study has formally examined the effects of this practice.

If this study demonstrates higher patient satisfaction and lower perceptions of pain and anxiety levels in patients who have social support in the in-clinic abortion procedure room, this could change standard procedures in the in-clinic abortion procedure room, allowing for more positive patient experiences.

详细描述

Having an abortion is a complexly emotional experience for many women. Women with strong social support, from a partner, friend or family member, report better psychological adjustment. During medication abortion, patients reported high satisfaction levels, in part, because of being able to share the experience with another person. During in-clinic abortion, patients report lower levels of anxiety when they have a support person (partner, spouse, friend or family member) in the post-abortion recovery room. Additionally, support persons indicate feeling they can successfully comfort the woman. In the abortion procedure room, doula support has a positive psychological impact on patients and decreases the need for additional clinic support resources. Because doula support in the abortion procedure room and social support in the post-abortion recovery room improves patient experience, it is reasonable to believe that having a support person in the procedure room may also improve patient experience. However, there are no data about the patient, support person, and health care provider's experience and satisfaction with a support person in the abortion procedure room.

This study aims to explore patient, support person, and health care providers' experience and satisfaction with social support in the abortion procedure room. Although some providers do allow a support person in the abortion procedure room, no study has formally examined the effects of this practice.

If this study demonstrates higher patient satisfaction and lower perceptions of pain and anxiety levels in patients who have social support in the in-clinic abortion procedure room, this could change standard procedures in the in-clinic abortion procedure room, allowing for more positive patient experiences.

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

性别
All
接受健康志愿者

入选标准

  • Any patient who presents and consents for dilation and curettage
  • Patient participants 17 and younger must have a legal guardian provide consent for participation, and the patient must provide assent
  • Ability to provide written informed consent in English and comply with all study procedures
  • Support Persons:
  • Any person 18 years and older who the patient selects to accompany as their support person
  • Ability to provide written informed consent in English and comply with all study procedures
  • Health Care Providers:
  • Any health center staff attending to the enrolled patient in both intervention and control arms of the study
  • Ability to provide written informed consent in English and comply with all study procedures

排除标准

  • Patients without a support person on-site willing to participate
  • Patients or support persons that are unable to provide written informed consent in English and comply with all study procedures.

研究组 & 干预措施

Control

No Intervention

This arm of participants will not experience the intervention of having a support person of the patient's choice support the patient during their abortion.

Support Person Intervention

Experimental

This arm of participants will experience the intervention of having a support person of the patient's choice support them during their abortion procedure.

干预措施: Support Person Intervention (Behavioral)

结局指标

主要结局

Anxiety

时间窗: 1 day

Evaluating anxiety through State Trait Anxiety Inventory (STAI)

次要结局

  • Perceived Pain(1 day)

研究者

发起方
Planned Parenthood of Southwest and Central Florida
申办方类型
Other
责任方
Sponsor

研究点 (2)

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