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Completed

NCT Number: NCT02543515

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

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

Completed

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Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Centro Hospitalar Tondela Viseu

Viseu, 3500, Portugal

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Office hysteroscopy

Procedure

diagnostic procedure

Other names: hysteroscopy,, mini-hysteroscopy

Primary outcomes

  1. office hysteroscopy in Nuligest

    Time frame: five to ten minutes after hystersocopy

    Pain score evaluated on a 10cm visual analogue scale

  2. office hysteroscopy in parous women

    Time frame: five to ten minutes after hystersocopy

    Pain score evaluated on a 10cm visual analogue scale

  3. 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

Secondary outcomes

  1. office hysteroscopy in post-menopausal women

    Time frame: five to ten minutes after hystersocopy

    Pain evaluated on a 10cm visual analogue scale

  2. office hysteroscopy and body mass index

    Time frame: five to ten minutes after hystersocopy

    Pain evaluated on a 10cm visual analogue scale

  3. 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

  4. 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

  5. office hysteroscopy in women with history of dysmenorrhea

    Time frame: five to ten minutes after hystersocopy

    Pain evaluated on a 10cm visual analogue scale

  6. office hysteroscopy in women with abnormal uterine bleeding

    Time frame: five to ten minutes after hystersocopy

    Pain evaluated on a 10cm visual analogue scale

  7. 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

Sponsors and collaborators

Lead sponsor

Centro Hospitalar Tondela-Viseu

Other

Collaborators

  • Antonio Pipa, M.D.
  • José Damasceno Costa, M.D.
  • Marta Fernandes, M.D. MSc
  • Raquel Oliveira, MSc.
  • Sonia Gonçalves, M.D
  • nurse Carla Santos
  • nurse Catarina Mota

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 7, 2015
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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