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Completed

NCT Number: 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

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".

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tarsus University

Mersin, Turkey, 33400, Turkey (Türkiye)

About this study

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".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Tarsus University

Other

Collaborators

  • Mersin University

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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