Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy: An Observational Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pelvic Girdle Pain
- Sponsor
- Centro Hospitalar Tondela-Viseu
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- office hysteroscopy in Nuligest
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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).
Investigators
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
Eligibility Criteria
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
Outcomes
Primary Outcomes
office hysteroscopy in Nuligest
Time Frame: five to ten minutes after hystersocopy
Pain score evaluated on a 10cm visual analogue scale
office hysteroscopy in parous women
Time Frame: 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
Time Frame: five to ten minutes after hystersocopy
Pain score evaluated on a 10cm visual analogue scale
Secondary Outcomes
- 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)