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A study to evaluate the pain and anxiety reducing effects of music during gynecological outpatient procedures.


- candidate number21046
- NTR NumberNTR4924
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-nov-2014
- Secondary IDs2014-28 METC Maxima Medisch Centrum
- Public TitleA study to evaluate the pain and anxiety reducing effects of music during gynecological outpatient procedures.
- Scientific TitleDoes music reduce pain and anxiety in office hysteroscopy, colposcopy and endometrial ablation? A randomized controlled trial.
- ACRONYMGENTLE trial.
- hypothesisThere is some evidence that patients tend to experience less pain and anxiety while listening to music during an office procedure like colposcopy, hysteroscopy of endometrial ablation. The aim of this study is to prove a significant reduction of pain while listening to music.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteriaDutch speaking females with the age of 18 or above, indication for office hysteroscopy, endometrial ablation or colposcopy, written informed consent.
- Exclusion criteriaHistory of conization or Manchester Fothergill operation, blindness, severe hearing impairment/ deafness.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 22-sep-2014
- planned closingdate
- Target number of participants202
- InterventionsThe intervention group get to listen to music of choice during the office procedure. The control group doesn’t listen to music and these patients will be treated as in the normal daily practice.
- Primary outcomeSignificant pain reduction using the Visual Analogue Scale(VAS).
- Secondary outcomeAnxiety reduction using STAI Heart rate Patient satisfaction Doctor satisfaction
- TimepointsTime points: 1.Just before consultation (questionnaire including State-Trait Anxiety Inventory list (STAI)and measurement of heart rate), 2. during procedure using Visual Analogue Scale at specific predefined moments. With colposcopy at the moment of biopsy or LEEP, with hysteroscopy at the moment of passage through internal os and with Novasure during ablation (VAS pain score and measurement of heart rate), 3.directly after the procedure (Short questionnaire including VAS pain score and STAI).
- Trial web sitenone
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIESDr. Marlies Bongers
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryThe aim of this study is to determine if patients who undergo an ambulatory hysteroscopy, colposcopy or Novasure endometrial ablation, experience less pain and/or anxiety with the addition of music to the procedure. Country of recruitment: the Netherlands.
- Main changes (audit trail)
- RECORD26-nov-2014 - 16-mrt-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl