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Trial Title:
The Effect of Mobile-Based Education Given to Patients Undergoing Gynecological Oncology Surgery on Quality of Life
NCT ID:
NCT05694208
Condition:
Gynecologic Cancer
Conditions: Keywords:
Gynecological oncology
Mobile application
Nursing care
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The women included in the study sample will be divided into two groups as experimental
and control groups according to randomization. Experimental group; the group to be
trained. control group; This is the group in which no attempt will be made other than
data collection.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Education Group
Description:
In the first pre-operative interview at the gynecological oncology outpatient clinic of
the relevant hospital, the purpose of the research will be explained to the patients and
an informed consent form will be filled. The patients in the experimental group will use
the mobile-based care support application developed within the scope of the research.
Arm group label:
Experimental group
Summary:
This study was planned in a randomized controlled prospective experimental design in
order to determine the effect of mobile-based education given to patients undergoing
gynecological oncology surgery on quality of life.
Research Hypotheses:
H1. Education given with mobile application in gynecological oncology patients positively
affects symptom control of patients.
H2. The education given with the mobile application in gynecological oncology patients
positively affects the quality of life of the patients.
Detailed description:
Power analysis was conducted to determine the number of people to be included in the
study. The power of the test was calculated with the G*Power 3.1 program. As a result of
the power analysis, the sample size should be 50, 25 experimental and 25 control groups,
at 95% power, 5% significance level, and 0.690 effect size (df=24; t=1,710). In the
research, it was aimed to reach a total of 70 women, 35 people in each group, considering
the high power of the test and the losses.
Introductory Information Form, Symptom Evaluation Form, Functional Assessment of Cancer
Therapy-General (FACT-G) and Turkish-Computer System Usability Questionnaire (T-CSUQ- SV)
planned to be used as data collection tools in the study.
The women included in the study sample will be divided into two groups as experimental
and control groups according to randomization. Experimental group; the group to be
trained. control group; This is the group in which no attempt will be made other than
data collection.
Statistical Analysis of Data: The data obtained in the research will be analyzed using
SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Homogeneity of
descriptive features between groups will be tested by chi-square analysis and independent
group t-test. The differentiation status of the scales between the groups will be
analyzed with the independent group t-test and the changes within the group will be
analyzed with the repeated measures ANOVA test.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Be over 18 years old
- Able to speak, read and understand Turkish
- Being scheduled for surgery due to a diagnosis of gynecological cancer
- Having internet access
- Using a smartphone
Exclusion Criteria:
- Having a diagnosis of active psychiatric illness
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Istanbul University-Cerrahpasa
Address:
City:
Avcılar
Zip:
34320
Country:
Turkey
Contact:
Last name:
Çisem Baştarcan
Start date:
February 1, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Istanbul University - Cerrahpasa (IUC)
Agency class:
Other
Source:
Istanbul University - Cerrahpasa (IUC)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05694208
