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Impact of the Different Information Channels in Reducing Anxiety in Participants of Cervical Cancer Screening

NCT05622760CompletedNAINTERVENTIONAL

Summary

When participating in population-based screening for cervical cancer, women experience great anxiety during the weeks of waiting since they learn that they have an altered screening result until the colposcopy is performed. In this study we want to verify how anxiety decreases when the information is improved and an audiovisual support is added when giving it.

Key Facts

Lead Sponsor

Biogipuzkoa Health Research Institute

Enrollment

140

Start Date

2022-05-17

Completion Date

2022-12-28

Study Type

INTERVENTIONAL

Official Title

Audiovisual Informative Project for the Participants of the Cervical Cancer Screening in Osakidetza

Interventions

Audiovisual informationWritten information

Conditions

Uterine Cervical NeoplasmsEarly Detection of CancerAnxietyClinical Trial

Eligibility

Age Range

25 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

* Patients who participate in the Osakidetza cervical cancer screening program and are referred to the colposcopy consultation of the Hospital Universitario Donostia due to an altered screening test.

Exclusion Criteria:

* Patients who have previously been in the colposcopy consultation or have gone to a private center to receive information about their altered result or to undergo colposcopy.

Outcome Measures

Primary Outcomes

Change in the level of anxiety measured by the STAI scale according to the information format

Change in the level of anxiety according to the information format Compare the level of anxiety between who have the information in audiovisual format and who have the traditional model in written format. For the analysis we will use the STAI (described in Study description). The analysis of the results will be done by comparing the basic situation of each participant and the response to the same survey after having the information provided. On the other hand, the results of the surveys between both randomized groups will be compared after having access to the information studied.

Time frame: Less than 6 weeks between the call notifying the altered result and the colposcopy

Change in the level of anxiety measured by the PSS14 scale according to the information format

Change in the level of anxiety according to the information format Compare the level of anxiety between who have the information in audiovisual format and who have the traditional model in written format. For the analysis we will use the PSS14 (described in Study description). The analysis of the results will be done by comparing the basic situation of each participant and the response to the same survey after having the information provided. On the other hand, the results of the surveys between both randomized groups will be compared after having access to the information studied.

Time frame: Less than 6 weeks between the call notifying the altered result and the colposcopy

Secondary Outcomes

Influence of waiting time for colposcopy on anxiety measured by the STAI scale

In this secondary objective, we analyze whether the waiting time from the day the patient knows that she has an altered test until the day of the colposcopy influences the level of anxiety. Generally, the patient has to wait from 2 to 6 weeks from being notified of the altered result until the colposcopy. We are going to group the patients into 3 groups (from 0 to 2 weeks of waiting, from 2 to 4 weeks and from 4 to 6 weeks of waiting) and we will compare the results of the STAI scale to see if this factor is significant in their perception of emotional stress.

Time frame: 6 weeks maxium

Influence of waiting time for colposcopy on anxiety measured by the PSS14 scale

In this secondary objective, we analyze whether the waiting time from the day the patient knows that she has an altered test until the day of the colposcopy influences the level of anxiety. Generally, the patient has to wait from 2 to 6 weeks from being notified of the altered result until the colposcopy. We are going to group the patients into 3 groups (from 0 to 2 weeks of waiting, from 2 to 4 weeks and from 4 to 6 weeks of waiting) and we will compare the results of the PSS14 scale to see if this factor is significant in their perception of emotional stress.

Time frame: 6 weeks maxium

Influence of academic level on anxiety measured by the STAI scale

The level of anxiety obtained through the STAI scale score will be stratified in the 6 educational level categories (none, primary, secondary, high school, university or professional training) to see if there are significant differences between them.

Time frame: 6 weeks maxium

Influence of academic level on anxiety measured by the PSS14 scale

The level of anxiety obtained through the PSS14 scale score will be stratified in the 6 educational level categories (none, primary, secondary, high school, university or professional training) to see if there are significant differences between them.

Time frame: 6 weeks maxium

Change in colposcopy pain perception according to anxiety level measured by the STAI scale

We are going to analyze the pain perceived during the colposcopy, using the VAS scale (Visual Analogue Scale of pain) and we will compare them according to the level of anxiety detected in the STAI scale. We want to determine whether the perception of pain worsens at a higher level of anxiety.

Time frame: 6 weeks maxium

Change in colposcopy pain perception according to anxiety level measured by the PSS14 scale

We are going to analyze the pain perceived during the colposcopy, using the VAS scale (Visual Analogue Scale of pain) and we will compare them according to the level of anxiety detected in the PSS14 scale. We want to determine whether the perception of pain worsens at a higher level of anxiety.

Time frame: 6 weeks maxium

Locations

Donostia University Hospital, San Sebastián, Spain

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.