AzTrials
AzTrials

CataractNCT04778098

Effect of Short Message Service Use on Anxiety

A study testing Received SMS reminder in people with Cataract, run by Kırklareli University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cataract
What is being tested?
Received SMS reminder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Jul 2020to 8 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients 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 them at home after discharge were included in the study.

Who cannot join

  • Patients did not volunteered to participate in the study and had not a personal cell phone were excluded in the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kırklareli University

    Kırklareli, 39100

Other trials in Turkey (Türkiye)

About this study

Official title: The Use of an SMS Reminder in Postoperative Medication Compliance in Patients Undergoing Cataract Surgery and Its Effect on Anxiety: A Randomized Controlled Study

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.

Read the detailed 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.

Conditions
Cataract
Being tested
Received SMS reminder
Keywords
anxiety, satisfaction, surgery, telenursing, text message
Medical subject headings
Cataract, Anxiety Disorders, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Received SMS reminderOther

    telenursing

Study groups in NCT04778098
Study groupRoleWhat they receive
SMS groupExperimentalAfter postoperative standard discharge education was provided to the patients in the SMS group, they were given an individualized written Postoperative Medication Reference Chart. The patient/relative, whose contact information was received, was informed that they would be reminded via text message (SMS). SMS reminders which were individualized according to the patient based on the doctor's directive, were sent to the patients in the SMS group by the researcher clinical nurse (A. Ş). SMS sending started on postoperative day 1 and ended on day seven. SAI was applied again to all patients 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 patients in the SMS group. Confirmation was obtained from the patients and their relatives that SMS reminders were received every day.
Receives: Other: Received SMS reminder
Control groupNo interventionthe Patient Identification Form and SAI were applied to patients in the control on the day of surgery (postoperative day 0). Routine discharge education was provided to all patients by clinical nurses. During the discharge of the patients 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 patients were given an individualized written Postoperative Medication Reference Chart indicating the dosage and application time of eye drops they must follow for seven days at home.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative level of anxiety after cataract surgery

    The primary point of the study was defined as determining the effect of using SMS, reminding about the intake of medication, on reducing postoperative level of anxiety.

    Measured: 24 months

Secondary outcomes (1)
  1. Level of patient satisfaction about received message after cataract surgery

    The second point of the study was defined as determining the effect of using SMS, reminding about the intake of medication, on level of patient satisfaction.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2021
  2. Study start3 Jul 2020
  3. Primary completion8 Feb 2021
  4. Study completion8 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04778098
Sponsor's protocol ID
2020/P0244
Status last verified
Feb 2021
First submitted
25 Feb 2021
Last updated
2 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Questions about this trial

What is this clinical trial studying?

A study testing Received SMS reminder in people with Cataract, run by Kırklareli University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative level of anxiety after cataract surgery (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.

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