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Music and Colposcopy in Women With Cervical Dysplasia.

Primary Purpose

Uterine Cervical Dysplasia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Headphones
No Headphones
Sponsored by
Zydolab - Institute of Cytology and Immune Cytochemistry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Uterine Cervical Dysplasia focused on measuring cervical dysplasia, colposcopy, anxiety, music, mozart, randomized controlled trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Zydolab - Institute of Cytology and Immune Cytochemistry
  • Department of Obstetrics and Gynecology of the Ruhr University Bochum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Music and colposcopy

Colposcopy without music

Arm Description

Women will hear Mozarts symphony Nr. 40 during the colposcopic examination

During the colposcopic examination women will not hear music

Outcomes

Primary Outcome Measures

Change in anxiety scores
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 Outcome Measures

Anxiety score after colposcopy
Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes after colposcopy.
Change in heart rate
The difference in heart rate before and after colposcopy will be measured.
Pain during examination
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
women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain').
general unpleasantness during examination
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").
Anxiety during examination
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
women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").

Full Information

First Posted
December 25, 2016
Last Updated
May 7, 2018
Sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry
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1. Study Identification

Unique Protocol Identification Number
NCT03005795
Brief Title
Music and Colposcopy in Women With Cervical Dysplasia.
Official Title
Does Mozart Reduces Anxiety in Women With Cervical Dysplasia? A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
May 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Dysplasia
Keywords
cervical dysplasia, colposcopy, anxiety, music, mozart, randomized controlled trial

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music and colposcopy
Arm Type
Experimental
Arm Description
Women will hear Mozarts symphony Nr. 40 during the colposcopic examination
Arm Title
Colposcopy without music
Arm Type
Active Comparator
Arm Description
During the colposcopic examination women will not hear music
Intervention Type
Device
Intervention Name(s)
Headphones
Intervention Description
Music can be heard through headphones
Intervention Type
Other
Intervention Name(s)
No Headphones
Intervention Description
No Headphones will be used.
Primary Outcome Measure Information:
Title
Change in anxiety scores
Description
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.
Time Frame
10 minutes before and after colposcopy
Secondary Outcome Measure Information:
Title
Anxiety score after colposcopy
Description
Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes after colposcopy.
Time Frame
10 minutes before and after colposcopy
Title
Change in heart rate
Description
The difference in heart rate before and after colposcopy will be measured.
Time Frame
10 minutes
Title
Pain during examination
Description
women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain').
Time Frame
10 minutes
Title
Pain after examination
Description
women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain').
Time Frame
10 minutes
Title
general unpleasantness during examination
Description
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").
Time Frame
10 minutes
Title
Anxiety during examination
Description
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")
Time Frame
10 minutes
Title
Overall Satisfaction
Description
women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").
Time Frame
10 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziad Hilal, M.D.
Organizational Affiliation
Zydolab - Institute of Cytology and Immune Cytochemistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zydolab - Institute of Cytology and Immune Cytochemistry
City
Dortmund
State/Province
NRW
ZIP/Postal Code
44137
Country
Germany
Facility Name
Department of Obstetrics and Gynecology of the Ruhr University Bochum
City
Herne
State/Province
NRW
ZIP/Postal Code
44625
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30204685
Citation
Hilal Z, Alici F, Tempfer CB, Rath K, Nar K, Rezniczek GA. Mozart for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial. Obstet Gynecol. 2018 Oct;132(4):1047-1055. doi: 10.1097/AOG.0000000000002876.
Results Reference
derived

Learn more about this trial

Music and Colposcopy in Women With Cervical Dysplasia.

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