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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Retrograde Intrarenal Surgery
Keywords: Mobile application
Patient education
Nursing
Patient outcome
Lead sponsor: Tarsus University
Sponsor class: OTHER
Collaborators: name: Mersin University
First posted: 2025-02-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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".

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".

Eligibility criteria: 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.

Primary outcomes:
measure: Pain score
timeFrame: 6 months
measure: Analgesic Consumption
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
measure: Surgical Fear
timeFrame: 6 months
Secondary outcomes:
measure: Duration of hospital stay
timeFrame: 6 months
measure: Complications
timeFrame: 6 months
measure: Readmissions and hospitilizations
timeFrame: 6 months
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Tarsus University
Study officials:
affiliation: Necmettin Erbakan University
name: Serpil Yüksel
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Gülay ALTUN UĞRAŞ
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Murat BOZLU
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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