The effects of additional information on fear and stress in women with an abnormal cervical smear result.

Rationale:

An abnormal Pap smear result can affect a woman’s life in a negative manner. Women do not anticipate abnormal smear results and are taken by surprise. It frequently results in fears of cancer and worries about reproduction. In order to reach the greatest benefit from the screening programme, it seems to be important to decrease the fear and anxiety, and to improve information supply.



Objective:

This study will be conducted to see whether providing information on an individual level reduces fear and stress in women with an abnormal cervical smear result referred to the colposcopy clinic.



Study design:

Randomized controlled trial.



Study population:

The study population will consist of all new patients, 18 years and older, who are referred for colposcopic evaluation due to an abnormal Pap smear result.



Intervention:

One group (A) will consist of patients who receive extra information on a personal level. The other group (B) will consist of patients who will receive no extra information on the Pap smear result, the colposcopy and the possible treatment.



Main study parameters:

The effect of information on the anxiety, fear and quality of life among women with an abnormal Pap smear result.
The differences in scores of anxiety, depression and quality of life between group A and B.



Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

A researcher will contact patients by phone after they have made their first appointment at the colposcopy clinic. The participants who are randomized in group A will receive additional information. On arrival, prior to their first appointment, all participating patients are requested to fill out the following validated anxiety, depression and quality of life surveys: Hospital Anxiety and Depression scale (HADS), the Spielberger State and Trait Anxiety Inventory (STAI), and the Rand 36, as well as a short self-administered questionnaire, containing questions on demographics, knowledge of cervical cancer, knowledge of Human Papillomavirus (HPV), and the provided information.

This study will be conducted to see whether providing information on an individual level reduces fear and stress in women with an abnormal cervical smear result referred to the colposcopy clinic.

All questionnaires will be completed just before the planned colposcopy.

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.