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

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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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Bari, Bari, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Premenopausal and postmenopausal women
Indication for in-office operative hysteroscopy

Exclusion criteria

Denied consent
Use of analgesic drugs before the procedure

Treatment and study plan

in-office hysteroscopy

Procedure

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

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study 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)

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jan 26, 2023
Registry last updated: Jan 14, 2025

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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Completed