Pelvic Girdle PainNCT02543515
Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy
An observational study of Pelvic Girdle Pain, run by Centro Hospitalar Tondela-Viseu at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Girdle Pain
- What is being tested?
- office hysteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- Mar 2015to Nov 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- refusal to participate in study innability to fill in the study questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy: An Observational Study
Study type:
Observational, prospective.
Read more
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
Read the 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).
- Conditions
- Pelvic Girdle Pain
- Being tested
- office hysteroscopy
- Keywords
- following hysteroscopy
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
office hysteroscopyProcedure or surgery
Also called hysteroscopy,, mini-hysteroscopy
diagnostic procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
office hysteroscopy in Nuligest
Pain score evaluated on a 10cm visual analogue scale
Measured: five to ten minutes after hystersocopy
office hysteroscopy in parous women
Pain score evaluated on a 10cm visual analogue scale
Measured: 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
Measured: five to ten minutes after hystersocopy
Secondary outcomes (7)
office hysteroscopy in post-menopausal women
Pain evaluated on a 10cm visual analogue scale
Measured: five to ten minutes after hystersocopy
office hysteroscopy and body mass index
Pain evaluated on a 10cm visual analogue scale
Measured: five to ten minutes after hystersocopy
office hysteroscopy and psychosocial profile (State-Trait Anxiety Inventory for Adults)
Pain evaluated on a 10cm visual analogue scale
Measured: five to ten minutes after hystersocopy
Women's Satisfaction with office hysteroscopy according to pain perceived
Pain evaluated on a 10cm visual analogue scale and satisfaction questionnaires
Measured: five to ten minutes after hystersocopy
office hysteroscopy in women with history of dysmenorrhea
Pain evaluated on a 10cm visual analogue scale
Measured: five to ten minutes after hystersocopy
office hysteroscopy in women with abnormal uterine bleeding
Pain evaluated on a 10cm visual analogue scale
Measured: five to ten minutes after hystersocopy
office hysteroscopy in women with previous surgery upon uterine cervix
Pain evaluated on a 10cm visual analogue scale
Measured: five to ten minutes after hystersocopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Tondela-Viseu
- Sponsor type
- University, hospital or other
- Collaborators
- Marta Fernandes, M.D. MSc, Sonia Gonçalves, M.D, José Damasceno Costa, M.D., Antonio Pipa, M.D., Raquel Oliveira, MSc., nurse Catarina Mota, nurse Carla Santos
- Responsible party
- Principal investigator, Antonio paulo, Centro Hospitalar Tondela-Viseu
- Investigators
- Antonio Paulo, MD, Principal investigator, Centro Hospitalar Tondela-Viseu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543515
- Sponsor's protocol ID
- ASP/asp
- Status last verified
- Jan 2017
- First submitted
- 29 Aug 2015
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy: An Observational Study
- ClinicalTrials.gov ID
- NCT02543515
- Acronym / sponsor ID
- ASP/asp
- Conditions
- Pelvic Girdle Pain
- Keywords
- following hysteroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centro Hospitalar Tondela-ViseuUniversity, hospital or other
- Collaborators
- Marta Fernandes, M.D. MSc, Sonia Gonçalves, M.D, José Damasceno Costa, M.D., Antonio Pipa, M.D., Raquel Oliveira, MSc., nurse Catarina Mota, nurse Carla Santos
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- refusal to participate in study innability to fill in the study questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| office hysteroscopyAlso: hysteroscopy,, mini-hysteroscopydiagnostic procedure | Procedure or surgery | – |
Primary outcome
office hysteroscopy in Nuligest
Time frame: five to ten minutes after hystersocopy
Pain score evaluated on a 10cm visual analogue scale
office hysteroscopy in parous women
Time frame: five to ten minutes after hystersocopy
Pain score evaluated on a 10cm visual analogue scale
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
7 secondary outcomes
office hysteroscopy in post-menopausal women
Time frame: five to ten minutes after hystersocopy
office hysteroscopy and body mass index
Time frame: five to ten minutes after hystersocopy
office hysteroscopy and psychosocial profile (State-Trait Anxiety Inventory for Adults)
Time frame: five to ten minutes after hystersocopy
Women's Satisfaction with office hysteroscopy according to pain perceived
Time frame: five to ten minutes after hystersocopy
office hysteroscopy in women with history of dysmenorrhea
Time frame: five to ten minutes after hystersocopy
office hysteroscopy in women with abnormal uterine bleeding
Time frame: five to ten minutes after hystersocopy
office hysteroscopy in women with previous surgery upon uterine cervix
Time frame: five to ten minutes after hystersocopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Paulo, MD principal investigator
Centro Hospitalar Tondela-Viseu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Girdle Pain, run by Centro Hospitalar Tondela-Viseu at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
office hysteroscopy in Nuligest (time frame: five to ten minutes after hystersocopy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.