Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy

Study Overview
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Brief Summary
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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

Detailed Description
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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).

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

Conditions
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Pelvic Girdle Pain

Intervention / Treatment
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* Procedure: office hysteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: refusal to participate in study innability to fill in the study questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: office hysteroscopy|diagnostic procedure|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| office hysteroscopy in Nuligest | Pain score evaluated on a 10cm visual analogue scale | five to ten minutes after hystersocopy | 
| office hysteroscopy in parous women | Pain score evaluated on a 10cm visual analogue scale | five to ten minutes after hystersocopy | 
| office hysteroscopy in previous C section and repeat C section | Pain score evaluated on a 10cm visual analogue scale | five to ten minutes after hystersocopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| office hysteroscopy in post-menopausal women | Pain evaluated on a 10cm visual analogue scale | five to ten minutes after hystersocopy | 
| office hysteroscopy and body mass index | Pain evaluated on a 10cm visual analogue scale | five to ten minutes after hystersocopy | 
| office hysteroscopy and psychosocial profile (State-Trait Anxiety Inventory for Adults) | Pain evaluated on a 10cm visual analogue scale | five to ten minutes after hystersocopy | 
| Women's Satisfaction with office hysteroscopy according to pain perceived | Pain evaluated on a 10cm visual analogue scale and satisfaction questionnaires | five to ten minutes after hystersocopy | 
| office hysteroscopy in women with history of dysmenorrhea | Pain evaluated on a 10cm visual analogue scale | five to ten minutes after hystersocopy | 
| office hysteroscopy in women with abnormal uterine bleeding | Pain evaluated on a 10cm visual analogue scale | five to ten minutes after hystersocopy | 
| office hysteroscopy in women with previous surgery upon uterine cervix | Pain evaluated on a 10cm visual analogue scale | five to ten minutes after hystersocopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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following hysteroscopy