Hysteroscopy
Conditions
Brief summary
This randomized controlled trial evaluated whether calming instrumental music reduces pain and anxiety and improves satisfaction during outpatient hysteroscopy in postmenopausal women.
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.
Interventions
OTHERMusic
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.
Participants underwent outpatient hysteroscopy in the same setting using the same standard procedure, without background music
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Postprocedural anxiety | 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. |
| Patient satisfaction | 1 minute (Immediately after hysteroscope withdrawal) | Patient satisfaction assessed immediately after the procedure using a 0-10 Numerical Rating Scale. |
Countries
Egypt
Outcome results
None listed