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

Effect of Music on Pain, Anxiety, and Satisfaction During Outpatient Hysteroscopy in Postmenopausal Women: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Hysteroscopy
• Intervention / Treatment: Other: Music; Other: No Intervention: Control group

Detailed Description

This randomized controlled trial included postmenopausal women undergoing diagnostic outpatient hysteroscopy for postmenopausal bleeding or abnormal transvaginal ultrasound findings suggestive of intrauterine pathology. Participants were randomized 1:1 to receive calming instrumental music during the procedure or standard care without background music. The study assessed procedural pain, postprocedural pain, anxiety, patient satisfaction, operator-rated ease of hysteroscope insertion, procedure duration, intrauterine pathology detection, and adverse events.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: music group	Other: Music; 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.
Placebo Comparator: non-music group	Other: No Intervention: Control group; Participants underwent outpatient hysteroscopy in the same setting using the same standard procedure, without background music

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprocedural anxiety	Anxiety assessed immediately after the procedure using a 0-10 Numerical Rating Scale, where 0 indicates no anxiety and 10 indicates maximum anxiety.	1 minute (Immediately after hysteroscope withdrawal)
Patient satisfaction	Patient satisfaction assessed immediately after the procedure using a 0-10 Numerical Rating Scale.	1 minute (Immediately after hysteroscope withdrawal)

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): January 1, 2026
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: January 4, 2025
• First Submitted That Met QC Criteria: January 4, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Sensory Art Therapies; Music Therapy
• Other Study ID Numbers: MUSIC POSTMENOPAUSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No