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

NCT05622760 | Completed DMC

• 1 other identifier: DICRA
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Cervical Neoplasms; Early Detection of Cancer; Anxiety; Clinical Trial

Keywords

uterine cervical neoplasms; anxiety; early detection of cancer; uterine cervical cancer screening; cervical cancer screening; cervical cancer; clinical trial; audiovisual intervention

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (6)

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

  6 weeks maxium

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

  6 weeks maxium

• Influence of academic level on anxiety measured by the STAI scale

  6 weeks maxium

• Influence of academic level on anxiety measured by the PSS14 scale

  6 weeks maxium

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

  6 weeks maxium

Study Arms (2)

Audiovisual information

EXPERIMENTAL

Group of participants to whom the information is given through an audiovisual medium.

Other: Audiovisual information

Written information

PLACEBO COMPARATOR

Group of participants to whom the information is given through the writing that is available on the website of the health organization.

Other: Written information

Interventions

Audiovisual information OTHER

The information provided to this group is in audiovisual format. This information is what has been designed with the aim of reducing the level of anxiety of patients who participate in cervical cancer screening.

Audiovisual information

Written information OTHER

The information provided to this group is in written format. This information is what is distributed to patients in the midwife's consultation and is available on the website of the health organization (Osakidetza)

Written information

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: This clinical trial is aimed at all people with a cervix, regardless of the gender that represents them. Although the vast majority are women, men with a cervix can participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogipuzkoa Health Research Institute: lead

Study Sites (1)

Donostia University Hospital

San Sebastián, Guipuzcoa, 20014, Spain

Location

Related Publications (2)

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.

  PMID: 16673626 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Mental Disorders

Study Officials

• David Del Valle, MD

  Osakidetza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization code is only known to a collaborator who fills the envelopes according to said code. The envelopes are distributed in order of arrival at the study, the researcher in charge of distributing them and recording the information does not know the randomization code. At the end of the study and registering all the data, the collaborator who has the code will deliver it to the principal investigator of the study. In all the envelopes there is some type of information so that the patients are also blind. The experimental group is given a sheet with the links to the videos and the other group is given written information, which is available on the health organization's website. In this way, no group feels that it does not receive information and we control said bias.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trial on quality of life where there are 2 groups. After signing the informed consents and completing the anxiety surveys, each participant is randomized and given the corresponding envelope.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: November 21, 2022
• Study Start: May 17, 2022
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-02

Locations

ES (1)