- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06812884
Effects of Education Given to RIRS With Mobile Application on Anxiety, Fear of Surgery, Pain, Analgesic Consumption, Length of Hospital Stay, Complication Development, Readmission and Hospitalization
May 30, 2026 updated by: Gamze BOZKUL, Tarsus University
Effects of Education Given to Retrograde Intrarenal Surgery Patients With Mobile Application on Anxiety, Fear of Surgery, Pain, Analgesic Consumption, Length of Hospital Stay, Complication Development, Readmission and Hospitalization
The aim of this study was to determine the effect of the education to be given with a mobile application to be developed for RIRC patients on preoperative anxiety, fear of surgery, postoperative pain level, analgesic consumption, length of hospital stay, development of complications in the first month, readmission and number of hospitalizations.
The study was planned as a prospective, two-arm (1:1), randomized controlled trial.
The study will be conducted with 68 patients in the urology clinic of a university hospital.
Patients will be randomly assigned to the control group and the mobile application training group.. Descriptive Information Form, Visual Analog Scale (VAS), Analgesic Consumption Monitoring Form, State Anxiety Scale, Surgical Fear Scale and Patient Monitoring Form will be used to collect the data.
"Introductory Information Form", 'State Anxiety Scale', and 'Surgical Fear Scale' will be applied to all patients before surgical intervention.
"State Anxiety Scale" and 'Surgical Fear Scale' will be administered both before and at the end of the trainings in the preoperative period.
Trainings and preoperative scales to be completed will be carried out when the patient is admitted to the clinic for surgery.
The group to be trained with the mobile application will be introduced to the application and the application will be downloaded to their phones, tablets or computers.
Then, the questions of the patients regarding the mobile application will be answered.
Patients in the control group will receive routine information in the clinic.
After the surgical intervention, "VAS" and "Analgesic Consumption Monitoring Form" will be applied to all patients.
The pain of the patients will be evaluated with VAS when they come to the postoperative room, at the 6th postoperative hour and at the 12th postoperative hour.
The amount of analgesia consumed by the patients within 24 hours postoperatively will be recorded in the Analgesia Consumption Form.
The duration of hospital stay will be recorded on the "Patient Follow-up Form" on the day of discharge.
Patients who underwent RIRC will be called by the investigators one month later and their complication development status, hospitalization/ rehospitalization status will be learned and recorded in the "Patient Follow-up Form".
Study Overview
Detailed Description
The aim of this study was to determine the effect of the education to be given with a mobile application to be developed for RIRC patients on preoperative anxiety, fear of surgery, postoperative pain level, analgesic consumption, length of hospital stay, development of complications in the first month, readmission and number of hospitalizations.
The study was planned as a prospective, two-arm (1:1), randomized controlled trial.
The study will be conducted with 68 patients in the urology clinic of a university hospital.
Patients will be randomly assigned to the control group and the mobile application training group.
Patients in the mobile application group will be trained with the mobile application, while patients in the control group will only receive routine care in the clinic.
Patients assigned to the mobile application group will be introduced to the education to be given with the mobile application and the application will be downloaded to their phones/tablets.
Descriptive Information Form, Visual Analog Scale (VAS), Analgesic Consumption Monitoring Form, State Anxiety Scale, Surgical Fear Scale and Patient Monitoring Form will be used to collect the data.
"Introductory Information Form", 'State Anxiety Scale', and 'Surgical Fear Scale' will be applied to all patients before surgical intervention.
"State Anxiety Scale" and 'Surgical Fear Scale' will be administered both before and at the end of the trainings in the preoperative period.
Trainings and preoperative scales to be completed will be carried out when the patient is admitted to the clinic for surgery.
The group to be trained with the mobile application will be introduced to the application and the application will be downloaded to their phones, tablets or computers.
Then, the questions of the patients regarding the mobile application will be answered.
Patients in the control group will receive routine information in the clinic.
After the surgical intervention, "VAS" and "Analgesic Consumption Monitoring Form" will be applied to all patients.
The pain of the patients will be evaluated with VAS when they come to the postoperative room, at the 6th postoperative hour and at the 12th postoperative hour.
The amount of analgesia consumed by the patients within 24 hours postoperatively will be recorded in the Analgesia Consumption Form.
The duration of hospital stay will be recorded on the "Patient Follow-up Form" on the day of discharge.
Patients who underwent RIRC will be called by the investigators one month later and their complication development status, hospitalization/ rehospitalization status will be learned and recorded in the "Patient Follow-up Form".
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Turkey
-
Mersin, Turkey, Turkey (Türkiye), 33400
- Tarsus University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 years of age or older,
- Elective RIRC planned,
- Conscious, oriented and cooperative,
- Written permission to participate in the study was obtained,
- Who speaks and understands Turkish,
- Literate,
- Not visually or hearing impaired,
- Not mentally disturbed,
- The person or caregiver has an android phone or tablet,
- Using an android phone or tablet for at least a year,
- Patients who state that they do not have any disability related to the use of technology will be included in the study.
Exclusion Criteria:
Emergency RIRC planned,
- Under 18 years old,
- Refused to participate in the research,
- Who doesn't speak Turkish,
- Illiterate,
- Undergoing other surgical interventions in conjunction with RIRC,
- Visually or hearing impaired,
- Neither they nor their caregiver has an android phone or tablet
- Have used a smartphone or tablet for less than one year,
- Patients who state that they have a disability related to the use of technology will not be included in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Mobile application group
"Introductory Information Form", 'State Anxiety Scale', and 'Surgical Fear Scale' will be applied to all patients before surgical intervention.
"State Anxiety Scale" and 'Surgical Fear Scale' will be administered both before and after the trainings in the preoperative period.
The trainings and the scales to be filled out before surgery will be carried out when the patient is admitted to the clinic for surgery.
The group to be trained with the mobile application will be introduced to the application and the application will be downloaded to their phones, tablets or computers.
After the surgical intervention, "VAS" and "Analgesic Consumption Monitoring Form" will be applied to all patients.
Patients' pain will be evaluated with VAS when they come to the postoperative room, postoperative 6th hour and postoperative 12th hour.
The amount of analgesia consumed by the patients within 24 hours postoperatively will be recorded in the Analgesia Consumption Form.
The duration of hospital stay wi
|
The mobile application will be introduced to the group to be trained and the application will be downloaded to their phones, tablets or computers.
|
|
No Intervention: Control group
Patients in the control group will receive the routine information provided in the clinic.
All patients will be administered "Descriptive Information Form", "State Anxiety Scale", and "Surgical Fear Scale" before surgical intervention.
"State Anxiety Scale" and 'Surgical Fear Scale' will be administered both before and at the end of the briefing in the preoperative period.
After the surgical intervention, "VAS" and "Analgesic Consumption Monitoring Form" will be applied to all patients.
The pain of the patients will be evaluated with VAS when they come to the postoperative room, at the 6th postoperative hour and at the 12th postoperative hour.
The amount of analgesia consumed by the patients within 24 hours postoperatively will be recorded in the Analgesia Consumption Form.
The duration of hospital stay will be recorded on the "Patient Follow-up Form" on the day of discharge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score
Time Frame: 6 months
|
Visual Analog Scale: It is a scale that provides a subjective assessment of pain on a horizontal or vertical line from 0 (no pain at all)-10 (very severe pain) to evaluate the level of pain (Wewers and Lowe, 1990).
|
6 months
|
|
Analgesic Consumption
Time Frame: 6 months
|
Analgesic Consumption Monitoring Form : In this form, the analgesics consumed by the patients in the first 24 hours after surgical intervention and their amounts will be recorded.
|
6 months
|
|
Anxiety
Time Frame: 6 months
|
Description: The State Anxiety Scale : In this study, the DAQ, which is structured to measure momentary feelings, was used.
Its Turkish validity and reliability was conducted by Öner and Le Compte in 1983.
The DAQ consists of 20 questions on a four-point Likert scale.
The statements in the DAQ are evaluated as not at all (1), a little (2), a lot (3) and completely (4).
In this section, the statements are divided into direct and reversed statements.
Inverted statements: 1st, 2nd, 5th, 5th, 8th, 8th, 10th, 11th, 15th, 16th, 19th, 20th items.
The total score of the reversed statements is subtracted from the total score of the direct statements and the number 50, which is the invariant value of the DAQ, is added to the value obtained and the DAQ score is calculated.
The scale score ranges between 20-80 and an increase in the score indicates an increase in the level of anxiety.
|
6 months
|
|
Surgical Fear
Time Frame: 6 months
|
Surgical Fear Scale: The Turkish validity and reliability study of the scale was conducted by Bağdigen and Karaman Özlü in 2018.
The questionnaire, which consists of eight items, has an 11-point Likert structure ranging from 0 (I am not afraid at all) to 10 (I am very afraid).
The questionnaire has two subscales indicating the fear of short-term and long-term consequences of surgery.
The subscale score is obtained by summing the scores of the four items in the subscales of the questionnaire.
The total score of the questionnaire will be obtained by summing the scores of the two subscales, with a minimum score of 0 and a maximum score of 80.
The Cronbach alpha coefficient of the scale was found to be 0.89, 0.86 for the short-term outcomes sub-dimension and 0.87 for the long-term outcomes (Bağdiven & Karaman Özlü, 2016).
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of hospital stay
Time Frame: 6 months
|
Patient Follow-up Form: This form consists of a chart recording the duration of hospital stay, the development of complications in the first month, the number of readmissions and hospitalizations after RIRC.
|
6 months
|
|
Complications
Time Frame: 6 months
|
Patient Follow-up Form: This form consists of a chart recording the duration of hospital stay, the development of complications in the first month, the number of readmissions and hospitalizations after RIRC.
|
6 months
|
|
Readmissions and hospitilizations
Time Frame: 6 months
|
Patient Follow-up Form: This form consists of a chart recording the duration of hospital stay, the development of complications in the first month, the number of readmissions and hospitalizations after RIRC.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gülay Altun Uğraş, Mersin University
- Principal Investigator: Murat Bozlu, Mersin University
- Principal Investigator: Serpil Yüksel, Necmettin Erbakan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 7. Gerlitz, R. (2017). Barriers and facilitators of preoperative education within Enhanced Recovery after Surgery (ERAS) programs. University of Lethbridge. Faculty of Health Sciences. Master of Nursing
- Aghamir SMK. Successful retrograde intrarenal surgery (RIRS) for a 2-centimeter stone in a chronic renal failure (CRF) patient. Int J Surg Case Rep. 2021 Oct;87:106375. doi: 10.1016/j.ijscr.2021.106375. Epub 2021 Sep 14.
- Abdelmowla, R. A. A., Hussein, A. H., Shahat, A. A., Ahmed, H. A., & Abdelmowla, M. A. A. (2017). Impact of nursing interventions and patients education on quality of life regarding renal stones treated by percutaneous nephrolithotomy. Journal of Nursing Education and Practice, 7(12), 52-63. https://doi.org/10.5430/jnep.v7n12p52
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2025
Primary Completion (Actual)
April 1, 2026
Study Completion (Actual)
May 30, 2026
Study Registration Dates
First Submitted
February 2, 2025
First Submitted That Met QC Criteria
February 2, 2025
First Posted (Actual)
February 6, 2025
Study Record Updates
Last Update Posted (Actual)
June 2, 2026
Last Update Submitted That Met QC Criteria
May 30, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TU-BOZKUL-011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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