Clinical trial NCT02543515: Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy
Official title: Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Girdle Pain
Keywords: following hysteroscopy
Lead sponsor: Centro Hospitalar Tondela-Viseu
Sponsor class: OTHER
Collaborators: name: Marta Fernandes, M.D. MSc
name: Sonia Gonçalves, M.D
name: José Damasceno Costa, M.D.
name: Antonio Pipa, M.D.
name: Raquel Oliveira, MSc.
name: nurse Catarina Mota
name: nurse Carla Santos
First posted: 2015-09-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult women scheduled for office hysteroscopy.

Eligibility criteria and informed consent:

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

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).

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

Primary outcomes:
measure: office hysteroscopy in Nuligest
timeFrame: five to ten minutes after hystersocopy
measure: office hysteroscopy in parous women
timeFrame: five to ten minutes after hystersocopy
measure: office hysteroscopy in previous C section and repeat C section
timeFrame: five to ten minutes after hystersocopy
Secondary outcomes:
measure: office hysteroscopy in post-menopausal women
timeFrame: five to ten minutes after hystersocopy
measure: office hysteroscopy and body mass index
timeFrame: five to ten minutes after hystersocopy
measure: office hysteroscopy and psychosocial profile (State-Trait Anxiety Inventory for Adults)
timeFrame: five to ten minutes after hystersocopy
measure: Women's Satisfaction with office hysteroscopy according to pain perceived
timeFrame: five to ten minutes after hystersocopy
measure: office hysteroscopy in women with history of dysmenorrhea
timeFrame: five to ten minutes after hystersocopy
measure: office hysteroscopy in women with abnormal uterine bleeding
timeFrame: five to ten minutes after hystersocopy
measure: office hysteroscopy in women with previous surgery upon uterine cervix
timeFrame: five to ten minutes after hystersocopy
Other outcomes:
Locations:
city: Viseu
country: Portugal
facility: Centro Hospitalar Tondela Viseu
Study officials:
affiliation: Centro Hospitalar Tondela-Viseu
name: Antonio Paulo, MD
role: PRINCIPAL_INVESTIGATOR
References: