the Effect of Music on Pain and Women Satisfaction During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05069077

Collaborator

Al Gezeera Hospital (Other)

110

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this study is to demonstrate the value of music in diagnostic outpatient hysteroscopy on patients' level of pain and satisfaction in postmenopausal women

Condition or Disease	Intervention/Treatment	Phase
Hysteroscopy	Other: Music Other: No music	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

the Effect of Music on Pain and Women Satisfaction During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women: a Randomized Controlled Trial

Anticipated Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

May 10, 2022

Anticipated Study Completion Date :

May 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: music group In the music group, music chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphones in order to maintain good communication and interaction between the participant and the doctor.	Other: Music In the music group, music that chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphones in order to maintain good communication and interaction between the participant and the doctor.
Other: non-music group Participants in the non-music group will undergo diagnostic outpatient hysteroscopy in the same setting and standard procedure without listening to any music.	Other: No music Participants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music.

Arm

Intervention/Treatment

Experimental: music group

In the music group, music chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphones in order to maintain good communication and interaction between the participant and the doctor.

Other: Music

In the music group, music that chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphones in order to maintain good communication and interaction between the participant and the doctor.

Other: non-music group

Participants in the non-music group will undergo diagnostic outpatient hysteroscopy in the same setting and standard procedure without listening to any music.

Other: No music

Participants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music.

Outcome Measures

Primary Outcome Measures

Intensity of pain [5 minutes]
Pain intensity will be assessed by visual analog scale during the procedure. visual analog scale ranging from 0 to 100

Secondary Outcome Measures

Intensity of pain [20 minutes]
Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 100

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings)

Exclusion Criteria:

patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University
Al Gezeera Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Samy aly ashour, assistant professor of obstetrics and gynecology, Cairo University

ClinicalTrials.gov Identifier:

NCT05069077

Other Study ID Numbers:

hysteroscopy menopause 8233

First Posted:

Oct 6, 2021

Last Update Posted:

Oct 6, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 6, 2021