跳至主要内容
临床试验/NCT04489602
NCT04489602Unknown不适用

Translation and Validation of the French Version of the ObsQoR-10 Questionnaire for the Evaluation of Recovery After Childbirth: the ObsQoR-10F Questionnaire

University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Validity of ObsQoR-10F questionnaire

研究概览

简要总结

Until recently, there was no validated scoring tool to assess recovery after childbirth. Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section (scheduled or unscheduled): the ObsQoR-11. The psychometric validation of the ObsQoR-11 confirms its reliability, its response to change, its acceptability and its feasibility (average filling time of 2 minutes, and the possibility to print the questionnaire on one page). The use of this score allows the investigators to quantify the quality of the patient's recovery between 0 and 110 (0 being a really poor recovery, and 110 a total recovery), by allocating a score from 0 to 10 for each item.

Since then, the initial version of ObsQoR-11 has evolved into a smaller version, ObsQoR-10, for which the pain items have been merged. Similarly, by assigning a score from 0 to 10 for each item, the ObsQoR-10 score allows to quantify the quality of the patient's recovery between 0 and 100 (0 being a very poor recovery, and 100 being full recovery).

There are currently no translations of this score into another language, but the investigators can easily assume that they will be done in the near future. French remains the fifth most spoken language in the world. The investigators therefore feel it is necessary to validate the translated version of the ObsQoR-10 score.

详细描述

Recovery after childbirth (by caesarean section or vaginal delivery) is a complex process, depending on the characteristics of the patient, the anaesthesia, and the need for surgery or an instrumental device. This event is a source of stress, anxiety and pain, and can also lead to postpartum complications. Studies evaluating interventions during childbirth traditionally focus on mortality and morbidity which, although important, do not describe the patient's experience or the quality of her recovery.

Scores for measuring the quality of post-operative recovery have been developed. These scoring tools accurately measure post-operative recovery by looking at some dimensions of the patient's experience. However, they have been developed and validated in non-obstetrical patients. They therefore contain aspects of recovery that are not relevant to delivery and postpartum. Furthermore, they do not include key elements, such as the ability to care for the newborn.

Until recently, there was no validated scoring tool to assess recovery after childbirth. Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section (scheduled or unscheduled): the ObsQoR-11. This multidimensional score is a questionnaire of 11 items evaluating: moderate pain, severe pain, nausea and vomiting, feeling of discomfort, shivering, feeling of comfort, ability to mobilize, ability to carry the newborn, ability to feed, ability to groom alone, and finally feeling of self-control. The psychometric validation of the ObsQoR-11 confirms its reliability, its response to change, its acceptability and its feasibility (average filling time of 2 minutes, and the possibility to print the questionnaire on one page). The use of this score allows to quantify the quality of the patient's recovery between 0 and 110 (0 being a really poor recovery, and 110 a total recovery), by allocating a score from 0 to 10 for each item.

This tool has the advantage of efficiently evaluating the concept of immediate postpartum recovery, with an acceptable feasibility for both the patient and the caregivers. Since then, the initial version of ObsQoR-11 has evolved into a smaller version, ObsQoR-10, for which the pain items have been merged. Similarly, by assigning a score from 0 to 10 for each item, the ObsQoR-10 score allows to quantify the quality of the patient's recovery between 0 and 100 (0 being a very poor recovery, and 100 being full recovery).

There are currently no translations of this score into another language, but the investigators can easily assume that they will be done in the near future. French remains the fifth most spoken language in the world. The investigators therefore feel it is necessary to validate the translated version of the ObsQoR-10 score.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • ≥ 18 years old);
  • French-speaking;
  • Admitted for spontaneous obstetrical labor, induction of obstetrical labor, or scheduled cesarean section;
  • Able to answer the questionnaire, alone or with the help of a third party;
  • Agreeing to participate in the study

排除标准

  • Psychiatric or neurological pathology compromising cooperation in the questionnaire validation protocol,
  • Psychological history (medical termination of pregnancy, foetal death in utero).

结局指标

主要结局

Validity of ObsQoR-10F questionnaire

时间窗: 2 days

Evaluate the validity of the French version of the ObsQoR-10 to assess immediate postpartum recovery (at 24 and 48 hours after vaginal delivery or Caesarean section).

次要结局

  • Validity of ObsQoR-10F questionnaire (Caesarean section)(2 days)

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验