Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05278767 |
| Other study ID # |
5312256939 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 25, 2020 |
| Est. completion date |
January 10, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Cukurova University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study was conducted as a randomized controlled trial to determine the effects of
e-mobile education and counselling service on self-care agency, body image, and quality of
life in patients undergoing bariatric surgery.
The sample of the study was determined using power analysis after making preliminary tests
with the patients who met the sample selection criteria in Isparta City Hospital Obesity
Center, and consisted of 51 (26 experiment, 25 control) patients. The patients in the
experimental group received e-mobile training and consultancy services with the mobile
application developed specifically for bariatric surgery that started before the operation
and lasted for 3 months. The data of the study were collected using the Personal Information
Form, Self-Care Agency, Body Image, and Moorehead Ardelt Quality of Life II (MA-II) Scales
prepared in accordance with the literature. In addition to descriptive statistics,
Chi-Square, Independent Samples t-test, Repeated Measures, Mann-Whitney U and Friedman tests
were used to evaluate the data.
A statistically significant difference was found in the mean scores of Self-Care Strength,
Body Image, MA-II and BMI of the patients in the experimental and control groups according to
the processes (p>0.05). There was no statistically significant difference between the groups
in terms of preoperative, 1st, 2nd, and 3rd month Self-Care Power, Body Image and MA-II scale
mean scores (p>0.05). There was a statistically significant difference between the groups in
favour of the experimental group in terms of the 1st, 2nd, and 3rd month BMI averages
(p<0.05).
Description:
This research was carried out as a randomized controlled interventional study to determine
the effect of e-mobile education and counseling service on self-care power, body image and
quality of life in patients undergoing bariatric surgery. The population of the study
consisted of patients who underwent bariatric surgery in Isparta City Hospital, Obesity
Center between July 2020 and July 2021. The sample consisted of patients who met the sample
selection criteria in Isparta City Hospital Obesity Center and agreed to participate in the
research verbally and in writing.
Considering that the education and counseling services provided to the patients who met the
inclusion criteria of the study and accepted to participate, might affect the effectiveness
of the education level, the education level was determined as a criterion, and the patients
were divided into the application and control groups using a simple random and stratified
randomization method. The first patient included in the study in randomization was determined
by the simple randomization method (coin-toss), and when a patient with the same education
level came, he was necessarily included in the other group. Thus, the sampled individuals in
the research group were divided into strata according to their education level. Five patients
were excluded from follow-up due to the fact that one patient (n=1) wanted to withdraw from
the study, three patients (n=3) could not be contacted, and one patient (n=1) developed
complications. It was completed with 51 patients.The data of the study were collected using
the Personal Information Form, Self-Care Strength Scale, Body Image Scale, Moorehead Ardelt
Quality of Life Scale II (MA-II) prepared in line with the literature. In addition, the
Quality Criteria Questionnaire for Health Information User (DISCERN) was used to evaluate the
reliability and quality of the written educational material that will form the content of the
mobile application, and the System Usability Scale was used to evaluate the functionality and
usability of the mobile application.
The data of the study were carried out with 2 groups as control (standard care) and
application (mobile application). Randomization was carried out after meeting the patients
who were planned to undergo bariatric surgery, treated in the obesity clinic, who met the
sampling criteria and agreed to participate in the study, and were informed about the purpose
of the study.
The study was conducted in 4 stages with patients undergoing bariatric surgery.
