Pain, PostoperativeNCT05700123
Non-pharmacological Methods for the Control of Anxiety and Pain During Outpatient Hysteroscopy
A study testing In-Office Hysteroscopy in people with Pain, Postoperative, run by University of Campania Luigi Vanvitelli at 3 sites in Italy.
Trial summary
The administration of pharmacological and non-pharmacological aids during in-office hysteroscopic surgery is often used to both relieve the patient from discomfort and facilitate the operator in performing the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- In-Office Hysteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 3 sitesItaly
- Study dates
- 9 May 2024to 10 Jan 2025
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Premenopausal and postmenopausal women
- Indication for in-office operative hysteroscopy
Who cannot join
- Denied consent
- Use of analgesic drugs before the procedure
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
University of Bari
Bari
University of Cagliari
Cagliari
University of Campania "Luigi Vanvitelli"
Naples, 80138
About this study
Official title: Non-pharmacological Methods for the Control of Anxiety and Pain During Outpatient Hysteroscopy (Metodiche Non Farmacologiche Per il Controllo di Ansia e Dolore Durante Isteroscopia Ambulatoriale)
The administration of pharmacological and non-pharmacological aids during in-office hysteroscopic surgery is often used to both relieve the patient from discomfort and facilitate the operator in performing the procedure. The investigators aim to test the hypothesis that watching a video clip or listening to music would act as non-pharmacological relief for reducing anxiety and pain during in-office hysteroscopy.
- Conditions
- Pain, Postoperative
- Being tested
- In-Office Hysteroscopy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Office HysteroscopyProcedure or surgery
In-office hysteroscopic procedures were conducted using a 5mm continuous flow Office Hysteroscope using a vaginoscopic, no-touch, approach
| Study group | Role | What they receive |
|---|---|---|
| Video | Experimental | Not described Receives: Procedure: In-Office Hysteroscopy |
| Music | Experimental | Not described Receives: Procedure: In-Office Hysteroscopy |
| Vocal-Local | Active comparator | Not described Receives: Procedure: In-Office Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The anxiety, evaluated by means of State-Trait Anxiety Inventory (STAI) questionaries
20 (better) - 80 (worse)
Measured: 24 hours
post-hysteroscopic pain, evaluated using a 1-10 Numeric Rating Scale (NRS)
1 (better) - 10 (worse)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start9 May 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Riemma, University of Campania Luigi Vanvitelli
- Investigators
- Pasquale Franciscis, MD PhD, Study chair, University of Campania Luigi VanvitelliGaetano Riemma, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700123
- Sponsor's protocol ID
- 0013700/i
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-pharmacological Methods for the Control of Anxiety and Pain During Outpatient Hysteroscopy (Metodiche Non Farmacologiche Per il Controllo di Ansia e Dolore Durante Isteroscopia Ambulatoriale)
- ClinicalTrials.gov ID
- NCT05700123
- Acronym / sponsor ID
- 0013700/i
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 9 May 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 26 Jan 2023 (actual)
- 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.
The administration of pharmacological and non-pharmacological aids during in-office hysteroscopic surgery is often used to both relieve the patient from discomfort and facilitate the operator in performing the procedure. The investigators aim to test the hypothesis that watching a video clip or listening to music would act as non-pharmacological relief for reducing anxiety and pain during in-office hysteroscopy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Video | Experimental | Procedure: In-Office Hysteroscopy |
| Music | Experimental | Procedure: In-Office Hysteroscopy |
| Vocal-Local | Active comparator | Procedure: In-Office Hysteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Premenopausal and postmenopausal women
- Indication for in-office operative hysteroscopy
Key exclusion criteria (2 listed)
- Denied consent
- Use of analgesic drugs before the procedure
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 |
|---|---|---|
| In-Office HysteroscopyIn-office hysteroscopic procedures were conducted using a 5mm continuous flow Office Hysteroscope using a vaginoscopic, no-touch, approach | Procedure or surgery | Music, Video, Vocal-Local |
Primary outcome
The anxiety, evaluated by means of State-Trait Anxiety Inventory (STAI) questionaries
Time frame: 24 hours
20 (better) - 80 (worse)
post-hysteroscopic pain, evaluated using a 1-10 Numeric Rating Scale (NRS)
Time frame: 24 hours
1 (better) - 10 (worse)
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 14 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Pasquale Franciscis, MD PhD study chair
University of Campania Luigi Vanvitelli
Gaetano Riemma principal investigator
University of Campania Luigi Vanvitelli
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Office Hysteroscopy in people with Pain, Postoperative, run by University of Campania Luigi Vanvitelli at 3 sites in Italy.
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 2 inclusion and 2 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 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
The anxiety, evaluated by means of State-Trait Anxiety Inventory (STAI) questionaries (time frame: 24 hours). The study lists 2 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 14 Jan 2025.