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

Pelvic Girdle Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543515
• Other study ID #: ASP/asp
• Status: Completed
• Phase: N/A
• First received: August 29, 2015
• Last updated: January 31, 2017
• Start date: March 2015
• Est. completion date: November 2015

Study information

• Verified date: January 2017
• Source: Centro Hospitalar Tondela-Viseu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Girdle Pain

Intervention

Procedure:
• office hysteroscopy
diagnostic procedure

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Tondela Viseu	Viseu

Sponsors (8)

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

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	office hysteroscopy in Nuligest	Pain score evaluated on a 10cm visual analogue scale	five to ten minutes after hystersocopy
Primary	office hysteroscopy in parous women	Pain score evaluated on a 10cm visual analogue scale	five to ten minutes after hystersocopy
Primary	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	office hysteroscopy in post-menopausal women	Pain evaluated on a 10cm visual analogue scale	five to ten minutes after hystersocopy
Secondary	office hysteroscopy and body mass index	Pain evaluated on a 10cm visual analogue scale	five to ten minutes after hystersocopy
Secondary	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
Secondary	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
Secondary	office hysteroscopy in women with history of dysmenorrhea	Pain evaluated on a 10cm visual analogue scale	five to ten minutes after hystersocopy
Secondary	office hysteroscopy in women with abnormal uterine bleeding	Pain evaluated on a 10cm visual analogue scale	five to ten minutes after hystersocopy
Secondary	office hysteroscopy in women with previous surgery upon uterine cervix	Pain evaluated on a 10cm visual analogue scale	five to ten minutes after hystersocopy