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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

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

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 Summary:

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).

Sponsor: Centro Hospitalar Tondela-Viseu

Current Primary Outcome:

• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: Centro Hospitalar Tondela-Viseu

Dates:
Date Received: August 29, 2015
Date Started: March 2015
Date Completion:
Last Updated: January 31, 2017
Last Verified: January 2017