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

NCT02543515 | Completed

• 1 other identifier: ASP/asp
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Girdle Pain

Keywords

following hysteroscopy

Outcome Measures

Primary Outcomes (3)

• office hysteroscopy in Nuligest

  Pain score evaluated on a 10cm visual analogue scale

  five to ten minutes after hystersocopy

• office hysteroscopy in parous women

  Pain score evaluated on a 10cm visual analogue scale

  five to ten minutes after hystersocopy

• 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 Outcomes (7)

• 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

• Women's Satisfaction with office hysteroscopy according to pain perceived

  five to ten minutes after hystersocopy

• office hysteroscopy in women with history of dysmenorrhea

  five to ten minutes after hystersocopy

Interventions

office hysteroscopy PROCEDURE

diagnostic procedure

Also known as: hysteroscopy,, mini-hysteroscopy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• refusal to participate in study innability to fill in the study questionnaires

Sponsors & Collaborators

• Centro Hospitalar Tondela-Viseu: lead
• Marta Fernandes, M.D. MSc: collaborator
• Sonia Gonçalves, M.D: collaborator
• José Damasceno Costa, M.D.: collaborator
• Antonio Pipa, M.D.: collaborator
• Raquel Oliveira, MSc.: collaborator
• nurse Catarina Mota: collaborator
• nurse Carla Santos: collaborator

Study Sites (1)

Centro Hospitalar Tondela Viseu

Viseu, 3500, Portugal

Location

MeSH Terms

Conditions

Pelvic Girdle Pain

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Antonio Paulo, MD

  Centro Hospitalar Tondela-Viseu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Obstetrician and Gynaecologist - Department of Obstetrics and Gynaecology, Hospital Centre Tondela-Viseu Assistant Professor Health Sciences Department, University of Aveiro - Portugal

Study Record Dates

• First Submitted: August 29, 2015
• First Posted: September 7, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 2, 2017

Record last verified: 2017-01

Locations

PT (1)