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

U

University of Campania Luigi Vanvitelli

Status

Completed

Conditions

Pain, Postoperative

Treatments

Procedure: In-Office Hysteroscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT05700123
0013700/i

Details and patient eligibility

About

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.

Enrollment

198 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Denied consent
  • Use of analgesic drugs before the procedure

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

198 participants in 3 patient groups

Video
Experimental group
Treatment:
Procedure: In-Office Hysteroscopy
Music
Experimental group
Treatment:
Procedure: In-Office Hysteroscopy
Vocal-Local
Active Comparator group
Treatment:
Procedure: In-Office Hysteroscopy

Trial contacts and locations

3

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Central trial contact

Gaetano Riemma, MD; Pasquale De Franciscis, MD PhD

Data sourced from clinicaltrials.gov

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