The Effect of Music on Pain and Anxiety During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women

NCT06767644 | Completed

• 1 other identifier: MUSIC POSTMENOPAUSE
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluated whether calming instrumental music reduces pain and anxiety and improves satisfaction during outpatient hysteroscopy in postmenopausal women.

Conditions

Hysteroscopy

Outcome Measures

Primary Outcomes (1)

• Intensity of pain

  Pain intensity during office hysteroscopy, defined as the maximum pain experienced during the procedure and recorded immediately after hysteroscope withdrawal using a 0-10 Numerical Rating Scale, where 0 indicates no pain and 10 indicates maximum pain.

  1 minute (Immediately after hysteroscope withdrawal)

Secondary Outcomes (2)

• Postprocedural anxiety

  1 minute (Immediately after hysteroscope withdrawal)

• Patient satisfaction

  1 minute (Immediately after hysteroscope withdrawal)

Study Arms (2)

music group

EXPERIMENTAL

Other: Music

non-music group

PLACEBO COMPARATOR

Other: No Intervention: Control group

Interventions

Music OTHER

Participants listened to self-selected calming instrumental, non-lyrical music from a pre-prepared culturally acceptable playlist. Music was started approximately 3 minutes before hysteroscope insertion and continued until hysteroscope withdrawal. It was played through a speaker at a comfortable conversational volume and adjusted according to patient preference, while maintaining clear verbal communication between the operator and the participant.

music group

No Intervention: Control group OTHER

Participants underwent outpatient hysteroscopy in the same setting using the same standard procedure, without background music

non-music group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women undergoing diagnostic outpatient hysteroscopy for postmenopausal bleeding and/or abnormal transvaginal ultrasound findings suggestive of intrauterine pathology.

You may not qualify if:

• Cervical pathology; previous cervical surgery that could interfere with hysteroscope passage; retroverted uterus; severe vaginal bleeding; known hearing impairment; psychiatric illness.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 10, 2025
• Study Start: February 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)