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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR2155 |
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Date of registration:
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04/01/2010 |
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Primary sponsor: |
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Public title:
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The effects of additional information on fear and stress in women with an abnormal cervical smear result.
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Scientific title:
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The effects of additional information on fear and stress in women with an abnormal cervical smear result. - colposcopy-fear study |
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Date of first enrolment:
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6/12/2007 |
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Target sample size:
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128 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2155 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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R.P.
Bie, de |
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Address:
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P.O box 9101
6500 HB
Nijmegen
The Netherlands |
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Telephone:
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Email:
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Affiliation:
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Name:
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R.P.
Bie, de |
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Address:
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P.O box 9101
6500 HB
Nijmegen
The Netherlands |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. New patient referred for colposcopy with an abnormal pap-smear result;
2. Signed informed consent;
3. Age 18 years or above;
4. Mentally capable to understand and comprehend the study and its implications;
5. Sufficient knowledge of the Dutch language to read and understand the information brochures, and to answer the questionnaires.
Exclusion criteria: A former referral for colposcopic evaluation due to an abnormal cervical smear result.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Anxiety, Stress, Abnormal cervical smear, Colposcopy
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Intervention(s)
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Group A will consist of patients who receive extra information on a personal level. Meaning that the pap-smear result, the colposcopy, and the possible treatment will be explained by phone. Questions from the patient will be answered. After this phone call extra brochures containing information on the study, the diagnosis, the colposcopy, and the possible treatment, will be sent by mail.
Group B will consist of patients who will conceive no extra information on the pap smear results, the colposcopy and the possible treatment. The patients will receive the usual/standard information brochures on colposcopy. The means of the study will be explained by phone. Questions from the patients will be answered.
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Primary Outcome(s)
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1. The scores on the Spielberger STATE and TRAIT Anxiety Inventory (STAI);
2. The effect of information on the anxiety, fear and quality of life among women with an abnormal pap-smear result.
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Secondary Outcome(s)
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1. Differences in scores of anxiety, depression and quality of life questionaires in and between group A and B;
2. Relations between demographic characteristics and questionaire scores;
3. Knowledge level of pap-smear results, HPV, and colposcopy in each group;
4. Differences in knowledge level of pap-smear results, HPV, and colposcopy between both groups;
5. Cross relations between knowledge, satisfaction with information, anxiety, depression, and quality of life in group A and B.
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Secondary ID(s)
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2007/072 / NL17056.091.07
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Source(s) of Monetary Support
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Radboud University Nijmegen Medical Centre
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