CClinicalTrials.gg
CompletedNCT05700123Updated Jan 14, 2025

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

An interventional study of In-Office Hysteroscopy in Pain, Postoperative, sponsored by University of Campania Luigi Vanvitelli. Completed at 3 sites in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by University of Campania Luigi Vanvitelli · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Pain, Postoperative

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In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 198 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

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Lead sponsor

University of Campania Luigi Vanvitelli is the lead sponsor of 170 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Denied consent
  • Use of analgesic drugs before the procedure
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
198 participants (actual)

Study arms

  • Experimental
    Video

    Procedure: In-Office Hysteroscopy

  • Experimental
    Music

    Procedure: In-Office Hysteroscopy

  • Active comparator
    Vocal-Local

    Procedure: In-Office Hysteroscopy

Interventions

  • ProcedureIn-Office Hysteroscopy

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

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What researchers measure

Primary outcomes

  1. The anxiety, evaluated by means of State-Trait Anxiety Inventory (STAI) questionaries

    20 (better) - 80 (worse)

    Time frame: 24 hours

  2. post-hysteroscopic pain, evaluated using a 1-10 Numeric Rating Scale (NRS)

    1 (better) - 10 (worse)

    Time frame: 24 hours

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Study locations

3 sites
  • University of Bari
    Bari, Italy
  • University of Cagliari
    Cagliari, Italy
  • University of Campania "Luigi Vanvitelli"
    Napoli, 80138, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05700123
Lead sponsor
University of Campania Luigi Vanvitelli
Responsible party
Gaetano Riemma (Principal Investigator, University of Campania Luigi Vanvitelli) — Principal investigator
First posted
Jan 26, 2023
Start date
May 9, 2024
Primary completion
Jan 10, 2025
Completion
Jan 10, 2025
Last update
Jan 14, 2025

Study contacts

Pasquale Franciscis, MD PhD
study chair · Università della Campania Luigi Vanvitelli
Gaetano Riemma
principal investigator · Università della Campania Luigi Vanvitelli

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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