Videos and Music for Reducing Anxiety and Pain During In-office Hysteroscopy

Pain, Postoperative Clinical Trial

— ViMAP-OH  

Official title:

Usefulness of Videos and Music for Reducing Anxiety and Pain During In-office Hysteroscopy (Strategie Non Farmacologiche Per il Controllo di Ansia e Dolore Durante Isteroscopia Ambulatoriale)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700123
• Other study ID #: 0013700/i
• Status: Recruiting
• Start date: May 9, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: May 2024
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Gaetano Riemma, MD
• Phone: 0039 3384847685
• Email: gaetano.riemma[@]unicampania.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Premenopausal and postmenopausal women

• Indication for in-office operative hysteroscopy

Exclusion Criteria:

• Denied consent

• Use of analgesic drugs before the procedure

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Italy	University of Campania "Luigi Vanvitelli"	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The anxiety, evaluated by means of State-Trait Anxiety Inventory (STAI) questionaries	20 (better) - 80 (worse)	24 hours
Primary	post-hysteroscopic pain, evaluated using a 1-10 Numeric Rating Scale (NRS)	1 (better) - 10 (worse)	24 hours