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

NCT ID: NCT06812884

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-03

Study Completion Date

2026-06-03

Brief Summary

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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

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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".

Conditions

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Retrograde Intrarenal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The assignment of the patients included in the study to the groups will be carried out by the researcher (SY), who is not involved in the data collection process, with the simple randomization method of random numbers table. The https://www.randomizer.org/ website will be utilized in the table formation. When the patient who will undergo RIRC comes to the urology clinic, researchers GB and MB will evaluate the patients in terms of inclusion criteria. When the patient meets the inclusion criteria and signs the informed consent form, GB will inform the researcher SY and SY will inform GB which group the patient will be assigned to. In this way, all researchers, patients, patients' relatives and clinic staff other than the HC will be blinded to group assignment. In order to prevent bias in statistical analyses, the data of the patients whose data collection process is completed will be coded as G1, G2 and G3 by the researcher GAU without specifying the group name and entered into the data

Study Groups

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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

Group Type EXPERIMENTAL

Education

Intervention Type OTHER

The mobile application will be introduced to the group to be trained and the application will be downloaded to their phones, tablets or computers.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education

The mobile application will be introduced to the group to be trained and the application will be downloaded to their phones, tablets or computers.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mersin University

OTHER

Sponsor Role collaborator

Tarsus University

OTHER

Sponsor Role lead

Responsible Party

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Gamze BOZKUL

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serpil Yüksel

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan University

Gülay ALTUN UĞRAŞ

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Murat BOZLU

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Locations

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Tarsus University

Mersin, Turkey, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 34534812 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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TU-BOZKUL-011

Identifier Type: -

Identifier Source: org_study_id

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