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临床试验/NCT02543515
NCT02543515已完成不适用

Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy: An Observational Study

Centro Hospitalar Tondela-Viseu1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
office hysteroscopy in Nuligest

研究概览

简要总结

Study type:

Observational, prospective.

Objectives:

Primary:

Identify psychosocial and clinical factors that predispose to the occurrence of pain following office hysteroscopy

Secondary:

Stratify risk factors for pain previous Cesarean section and pain score repeat C section and pain score post-menopausal and pain score type of delivery and pain score body mass index and pain score history of dysmenorrhea and pain score, abnormal uterine bleeding and pain score previous surgery upon uterine cervix and pain score Characterize women's psychosocial profile and pain score Establish anxiety as a factor influencing pain perception using (State-Trait Anxiety Inventory for Adults).

Determine if there is a specified population who would benefit from procedure under anaesthesia

详细描述

Authors tend to compare pain in hysteroscopy in groups by scope size and variation in technique (e.g. 3mm versus 5mm scopes; vaginoscopic versus traditional speculum insertion approach), so score results reflect relative improvement in tolerability between groups, and they do not have as control an examination expected to be free of suffering.

To the investigators' knowledge there has to date never been an adequate judgement of the proportion of women in the group where pain is felt and should therefore be expected. Focus has always been put on the group of patients who are pain free (or where it is deemed acceptable).

Stating office hysteroscopy is painless because VAS score is halved by miniaturization seems an arbitrary statement for a small, but never the less important group of women.

It should be interesting to investigate factors which might contribute to pain in office hysteroscopy despite the fact the majority of the group will bear mild or no pain. The investigator believes that although reduction of scope size has brought about significant reduction in distress, it remains a painful procedure for some patients and therefore subjecting them to this ordeal may be regarded as an aggression; pain control interventions to reduce suffering might be considered (anxiolytic drugs, local, para-cervical or even general anaesthesia could be of interest in selected cases).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women scheduled for office hysteroscopy Written informed consent; diagnosis of uterine abnormal bleeding, sonographic evidence of thickened endometrium, sterility workup, endometrial polyps or sub mucous myoma, foreign body extraction or insertion (i.e. sterilization) or other condition with indication for procedure and who meet study eligibility criteria; ability to fill in the study questionnaires.

排除标准

  • refusal to participate in study innability to fill in the study questionnaires

结局指标

主要结局

office hysteroscopy in Nuligest

时间窗: five to ten minutes after hystersocopy

Pain score evaluated on a 10cm visual analogue scale

office hysteroscopy in parous women

时间窗: five to ten minutes after hystersocopy

Pain score evaluated on a 10cm visual analogue scale

office hysteroscopy in previous C section and repeat C section

时间窗: five to ten minutes after hystersocopy

Pain score evaluated on a 10cm visual analogue scale

次要结局

  • Women's Satisfaction with office hysteroscopy according to pain perceived(five to ten minutes after hystersocopy)
  • office hysteroscopy in post-menopausal women(five to ten minutes after hystersocopy)
  • office hysteroscopy and body mass index(five to ten minutes after hystersocopy)
  • office hysteroscopy and psychosocial profile (State-Trait Anxiety Inventory for Adults)(five to ten minutes after hystersocopy)
  • office hysteroscopy in women with previous surgery upon uterine cervix(five to ten minutes after hystersocopy)
  • office hysteroscopy in women with history of dysmenorrhea(five to ten minutes after hystersocopy)
  • office hysteroscopy in women with abnormal uterine bleeding(five to ten minutes after hystersocopy)

研究者

发起方
Centro Hospitalar Tondela-Viseu
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio paulo

Consultant Obstetrician and Gynaecologist - Department of Obstetrics and Gynaecology, Hospital Centre Tondela-Viseu Assistant Professor Health Sciences Department, University of Aveiro - Portugal

Centro Hospitalar Tondela-Viseu

研究点 (1)

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