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Non-pharmacological Methods for the Control of Anxiety and Pain During Outpatient Hysteroscopy

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05700123
Enrollment
198
Registered
2023-01-26
Start date
2024-05-09
Completion date
2025-01-10
Last updated
2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Brief 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. 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.

Interventions

In-office hysteroscopic procedures were conducted using a 5mm continuous flow Office Hysteroscope using a vaginoscopic, no-touch, approach

Sponsors

University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Premenopausal and postmenopausal women * Indication for in-office operative hysteroscopy

Exclusion criteria

* Denied consent * Use of analgesic drugs before the procedure

Design outcomes

Primary

MeasureTime frameDescription
The anxiety, evaluated by means of State-Trait Anxiety Inventory (STAI) questionaries24 hours20 (better) - 80 (worse)
post-hysteroscopic pain, evaluated using a 1-10 Numeric Rating Scale (NRS)24 hours1 (better) - 10 (worse)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026