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

University of Campania Luigi Vanvitelli198 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

198

Conditions

Pain, Postoperative

Interventions

In-Office HysteroscopyPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Premenopausal and postmenopausal women * Indication for in-office operative hysteroscopy Exclusion Criteria: * Denied consent * Use of analgesic drugs before the procedure

Locations (3)

University of Bari

Bari, Italy

University of Cagliari

Cagliari, Italy

University of Campania "Luigi Vanvitelli"

Napoli, Italy

Outcomes

Primary Outcomes

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

20 (better) - 80 (worse)

Time frame: 24 hours

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

1 (better) - 10 (worse)

Time frame: 24 hours

Data from ClinicalTrials.gov

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