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OpenTrials
Completed

NCT Number: NCT03005795

Music and Colposcopy in Women With Cervical Dysplasia.

To assess the effect of music during colposcopy on women´s anxiety.

Completed

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Key information

Conditions

Uterine Cervical Dysplasia Anxiety Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Mental Disorders Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zydolab - Institute of Cytology and Immune Cytochemistry, Dortmund, North Rhine-Westphalia, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Headphones

Device

Music can be heard through headphones

No Headphones

Other

No Headphones will be used.

Primary outcomes

  1. Change in anxiety scores

    Time frame: 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 outcomes

  1. Anxiety score after colposcopy

    Time frame: 10 minutes before and after colposcopy

    Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes after colposcopy.

  2. Change in heart rate

    Time frame: 10 minutes

    The difference in heart rate before and after colposcopy will be measured.

  3. Pain during examination

    Time frame: 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').

  4. Pain after examination

    Time frame: 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').

  5. general unpleasantness during examination

    Time frame: 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").

  6. Anxiety during examination

    Time frame: 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")

  7. Overall Satisfaction

    Time frame: 10 minutes

    women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").

Sponsors and collaborators

Lead sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Other

Registry information

Official study title

Does Mozart Reduces Anxiety in Women With Cervical Dysplasia? A Randomized Controlled Trial.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2016
Registry last updated
May 8, 2018

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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