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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02543515
Enrollment
100
Registered
2015-09-07
Start date
2015-03-31
Completion date
2015-11-30
Last updated
2017-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Girdle Pain

Keywords

following hysteroscopy

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).

Interventions

diagnostic procedure

Sponsors

Marta Fernandes, M.D. MSc
CollaboratorUNKNOWN
Sonia Gonçalves, M.D
CollaboratorUNKNOWN
José Damasceno Costa, M.D.
CollaboratorUNKNOWN
Antonio Pipa, M.D.
CollaboratorUNKNOWN
Raquel Oliveira, MSc.
CollaboratorUNKNOWN
nurse Catarina Mota
CollaboratorUNKNOWN
nurse Carla Santos
CollaboratorUNKNOWN
Centro Hospitalar Tondela-Viseu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
office hysteroscopy in Nuligestfive to ten minutes after hystersocopyPain score evaluated on a 10cm visual analogue scale
office hysteroscopy in parous womenfive to ten minutes after hystersocopyPain score evaluated on a 10cm visual analogue scale
office hysteroscopy in previous C section and repeat C sectionfive to ten minutes after hystersocopyPain score evaluated on a 10cm visual analogue scale

Secondary

MeasureTime frameDescription
Women's Satisfaction with office hysteroscopy according to pain perceivedfive to ten minutes after hystersocopyPain evaluated on a 10cm visual analogue scale and satisfaction questionnaires
office hysteroscopy in women with history of dysmenorrheafive to ten minutes after hystersocopyPain evaluated on a 10cm visual analogue scale
office hysteroscopy in post-menopausal womenfive to ten minutes after hystersocopyPain evaluated on a 10cm visual analogue scale
office hysteroscopy in women with previous surgery upon uterine cervixfive to ten minutes after hystersocopyPain evaluated on a 10cm visual analogue scale
office hysteroscopy in women with abnormal uterine bleedingfive to ten minutes after hystersocopyPain evaluated on a 10cm visual analogue scale
office hysteroscopy and body mass indexfive to ten minutes after hystersocopyPain evaluated on a 10cm visual analogue scale
office hysteroscopy and psychosocial profile (State-Trait Anxiety Inventory for Adults)five to ten minutes after hystersocopyPain evaluated on a 10cm visual analogue scale

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026