NCT06318702

Brief Summary

This is a randomised controlled study.The study was conducted to determine the effect of the constructivist education model given to women on gynecological cancer awareness, health Anxiety and spiritual well-being in women . The study population was composed of women living in Kastamonu. Women will be assigned to control and experimental groups. Women in the control group will receive gynecological education from Cancer Early Diagnosis, Screening and Education Centers (KETEM). The other group will receive gynecological cancer education based on the constructivist model.The hypotheses of the study are as follows: H0: The of constructivist learning model -based health education programme does not have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety. H1: The of constructivist learning model -based health education programme have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2023

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

26 days

First QC Date

March 13, 2024

Last Update Submit

March 18, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • gynecologic cancer awareness

    comparing the two groups in terms of gynecologic cancer awareness scores. Gynaecological cancer awareness scale will use for data collecting. This scale consists of 41 items and four sub-dimensions, with a minimum score of 41 and a maximum score of 205.The awareness of women is greater the higher the scores obtained from the scale.

    before education, after education, 4 weeks after education

  • spiritual well-being

    comparing the two groups in terms of spiritual well-being scores.Three-Factor Spiritual Well-Being Scale will use for collecting data.The scale is graded on a 5-point Likert scale (1=Not at all appropriate for me, 2=Not appropriate for me, 3=A little appropriate for me, 4=Quite appropriate for me, 5=Exactly appropriate for me). . An increase in the score obtained from the scale indicates an increase in the spiritual well-being of the individual

    before education, after education, 4 weeks after education

  • health anxiety scores

    comparison of the two groups in terms of health anxiety scores.Health Anxiety Inventory will use for data collecting.. It is an 18-item self-report inventory. Each item is scored from 0 to 3 The maximum score that can be obtained from the scale is 54 and higher scores indicate higher levels of HAI

    before education, after education, 4 weeks after education

Study Arms (2)

KETEM

NO INTERVENTION

This group was given a three-week standard gynecological cancer education program by the Cancer Early Diagnosis, Screening and Education Centers (KETEM) unit.

constructivist model group

EXPERIMENTAL

Gynecologic cancer education was given to the intervention group for 3 weeks based on the constructivist education model, taking into account the assimilation, adaptation and balancing stages of education.

Other: Education

Interventions

is an education program implemented to raise women's awareness about reproductive health and to help them adopt healthy habits.

constructivist model group

Eligibility Criteria

Age18 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being 18 years old,
  • being willing to participate in this study

You may not qualify if:

  • having any neuropsychiatric disorder,
  • having any physical or mental illness,
  • being diagnosed with gynecological cancer,
  • not attending theoretical trainings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu University

Merkez, Kastamonu, 37150, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Midwifery

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 19, 2024

Study Start

December 25, 2023

Primary Completion

January 20, 2024

Study Completion

February 20, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations