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Completed

NCT Number: NCT06767644

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

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

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Key information

Conditions

Hysteroscopy

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

No Intervention: Control group

Other

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

Primary outcomes

  1. Intensity of pain

    Time frame: 1 minute (Immediately after hysteroscope withdrawal)

    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.

Secondary outcomes

  1. Postprocedural anxiety

    Time frame: 1 minute (Immediately after hysteroscope withdrawal)

    Anxiety assessed immediately after the procedure using a 0-10 Numerical Rating Scale, where 0 indicates no anxiety and 10 indicates maximum anxiety.

  2. Patient satisfaction

    Time frame: 1 minute (Immediately after hysteroscope withdrawal)

    Patient satisfaction assessed immediately after the procedure using a 0-10 Numerical Rating Scale.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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