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).
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.
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 group | Role | What they receive |
|---|---|---|
| SMS group | Experimental | After 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 group | No intervention | the 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.
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)
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.
- First posted2 Mar 2021
- Study start3 Jul 2020
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Figen Dıgın, Kırklareli University
- Investigators
- Figen Dığın, PhD, Principal investigator, Kırklareli University, Kırklareli, Turkey
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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04778098
- Acronym / sponsor ID
- 2020/P0244
- Conditions
- Cataract
- Keywords
- anxiety, satisfaction, surgery, telenursing, text message
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS group | Experimental | Other: Received SMS reminderAfter 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. |
| Control group | No intervention | –the 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients did not volunteered to participate in the study and had not a personal cell phone were excluded in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Received SMS remindertelenursing | Other | SMS group |
Primary outcome
postoperative level of anxiety after cataract surgery
Time frame: 24 months
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.
1 secondary outcome
Level of patient satisfaction about received message after cataract surgery
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Figen Dığın, PhD principal investigator
Kırklareli University, Kırklareli, Turkey
1 site in 1 country: see every site and its status.
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.