Uterine Cervical Dysplasia
Conditions
Keywords
cervical dysplasia, colposcopy, anxiety, music, mozart, randomized controlled trial
Brief summary
To assess the effect of music during colposcopy on women´s anxiety.
Interventions
DEVICEHeadphones
Music can be heard through headphones
OTHERNo Headphones
No Headphones will be used.
Sponsors
Zydolab - Institute of Cytology and Immune Cytochemistry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* women referred for colposcopy due to cervical abnormalities * We included women if they attended colposcopy for the first time
Exclusion criteria
* pregnant women * presence of a language barrier * known anxiety disorder or depression * history of conization or other treatments on the cervix uteri * known oncological disorder * auditory defect * cardiovascular disease * inadequate colposcopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety scores | 10 minutes before and after colposcopy | Each women completes the state anxiety questionnaire (state-trait anxiety inventory \[STAI\]) 10 minutes before and 10 minutes after colposcopy. The difference in scores before and after colposcopy will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in heart rate | 10 minutes | The difference in heart rate before and after colposcopy will be measured. |
| Pain during examination | 10 minutes | women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain'). |
| Pain after examination | 10 minutes | women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain'). |
| Anxiety score after colposcopy | 10 minutes before and after colposcopy | Each women completes the state anxiety questionnaire (state-trait anxiety inventory \[STAI\]) 10 minutes after colposcopy. |
| Anxiety during examination | 10 minutes | women scores their anxiety during colposcopy using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (no anxiety at all) to 10 (worst imaginable anxiety) |
| Overall Satisfaction | 10 minutes | women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (maximally unsatisfied) to 10 (maximally satisfied). |
| general unpleasantness during examination | 10 minutes | women scores their feeeling during colposcopy using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (not at all unpleasant) to 10 (extremely unpleasant). |
Countries
Germany
Outcome results
None listed