Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04778098 |
| Other study ID # |
2020/P0244 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 3, 2020 |
| Est. completion date |
February 8, 2021 |
Study information
| Verified date |
February 2021 |
| Source |
Kirklareli University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Paticipants undergoing cataract surgery find postoperative medication management
difficult and are anxious about this issue. Differences in the number of medications and
frequency of administration can be lead to confusion in participants.
Aims and objectives: The aim of this randomized-controlled study was to evaluate the effect
of using SMS, which reminds about the intake of medication, on reducing postoperative anxiety
in participants undergoing cataract surgery.
Design: Randomized controlled study.
Description:
This randomized controlled study was conducted with the participation of 82 patients in the
ophthalmology clinic of a private hospital between July 2020 and February 2021. Participants
who underwent cataract surgery in a private hospital constituted the population of the study.
Based on the findings in the literature (Karaman Özlü et al., 2016) (mean score of the State
Anxiety Inventory 27.54±3.25), the minimum number of participants to be included in the
sample was determined to be 82 (41 subjects-41 controls), each group consisting of 41 people
by predicting a confidence interval of 99.9%, an error rate of 5%, and a power of 95%.
Participants who were adults, volunteered to participate in the study, accepted
randomization, could communicate in Turkish, had a personal cell phone, could read text
messages or were illiterate and had a relative to help participants at home after discharge
were included in the study.
Data Collection Tools The study data were collected using the Patient Identification Form and
Patient Satisfaction Form.
Patient Identification Form: The form prepared by the investigater with the help of the
literature (Gülşen & Akansel, 2020; & Lim et al., 2018) consisted of 8 questions examining
the individual variables (age, gender, education level, marital status, comorbidity, working
status and the patient's state of living alone, and the experience of cataract).
State Anxiety Inventory (SAI) In 1970, Spielberg et al. developed the State Anxiety
Inventory, and Oner and Le Compte carried out its reliability and validity studies. According
to 20 expressions with inventory, the individual may determine his or her feelings at a
specific location and time. The State Anxiety Inventory are scored between 20 and 80. A
higher score suggests a high anxiety level. The Cronbach alpha for Turkish version of the SAI
was 0.94 to 0.96 (Öner & Le Compte, 1983; Öner, 2008). In this study, the coefficient of
Cronbach alpha was calculated to be 0.93 for the inventory.
Patient Satisfaction Form The form consisted of one question about participants' satisfaction
with receiving an SMS reminder. The satisfaction level of participants was classified into
four levels. The value "0" was determined as "Not satisfied at all," and the value "3" was
determined as "Very satisfied." Postoperative Medication Reference Chart It is a "chart"
including the dosage and application time of all eye drops until postoperative day seven,
which is the second control of the participant according to the doctor's directive.
Medications were individualized for each participant by the investigater clinical nurse
according to the doctor's directive.
Data Collection Before starting the data collection, 82 participants who met the sampling
acceptance criteria were prospectively identified.
The investigater provided information about the study, the aim and significance of the study,
and the investigater to the individuals hospitalized in the ophthalmology service for
cataract surgery, and then informed consent was obtained in writing from the individuals.
Randomization was done by coin tossing (those who came up tails were included in the SMS
group, and those who came up heads were included in the control group), and according to the
results, the Patient Identification Form and SAI were applied to all participants in the
control and SMS groups on the day of surgery (postoperative day 0). Routine discharge
education was provided to all participants by clinical nurses. During the discharge of the
participants in the control group, they were informed about the change of dressing on the
next day (postoperative day one) and control in the outpatient clinic on postoperative day
seven. The participants were given an individualized written Postoperative Medication
Reference Chart indicating the dosage and application time of eye drops participants must
follow for seven days at home.
SMS group After postoperative standard discharge education was provided to the participants
in the SMS group, participants were given an individualized written Postoperative Medication
Reference Chart indicating the dosage and application time of eye drops participants must
follow for seven days at home. The participants/relative, whose contact information was
received, was informed that they would be reminded via SMS. SMS reminders such as "Dear x, do
not forget to apply your eye drop called X as 5 drops three times a day and your eye drop
called X as 2 drops three times a day. Investigater hope you get well soon," which were
individualized according to the participant based on the doctor's directive, were sent to the
participants in the SMS group by the investigater clinical nurse (A. Ş). SMS sending started
on postoperative day 1 and ended on day seven.
SAI was applied again to all participants who came to the outpatient clinic for control on
postoperative day seven. Unlike the control group, the "Patient Satisfaction Form," which was
prepared for the use of SMS reminders, was applied to the participants in the SMS group.
Confirmation was obtained from the participants and their relatives that SMS reminders were
received every day.
Randomization Randomization (1:1 allocation ratio) was determined by the simple randomization
method (coin tossing). As a result of coin tossing, participants who came up tails were
allocated to the SMS group (n = 41), and participants who came up heads were allocated to the
control group (n = 41), (Figure 1).
Blinded Due to the nature of the intervention, the participants and the investigaters could
not be blinded to the intervention (SMS sending) since open participation was required.
