NCT06891339

Brief Summary

The aim of this study is to evaluate whether a patient-centered mobile application used during the perioperative period can improve anxiety, complications, comfort, and patient satisfaction compared to standard care.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

March 13, 2025

Last Update Submit

March 18, 2025

Conditions

Keywords

Laparoscopic cholecystectomy, surgical patient, nursing care

Outcome Measures

Primary Outcomes (1)

  • The effect of a patient-oriented mobile application used by laparoscopic cholecystectomy patients in the perioperative period on anxiety, complications, comfort and satisfaction.

    To evaluate whether it can improve patients' concerns, complications, comfort, and patient satisfaction regarding surgery.

    2 months

Study Arms (2)

The effect of a patient-oriented mobile application

EXPERIMENTAL

Experimental Group: Patients will receive information about the mobile app and install it for free. Preoperative education, pain monitoring, and complication tracking will be conducted via the app. Video consultations will be available for wound care. On surgery day, they will receive standard care. Anxiety will be assessed on postoperative day 1, and daily follow-ups will continue until day 7, when they will complete the Comfort Scale, Patient Satisfaction Questionnaire, and State Anxiety Inventory via the app.

Other: mobile application

standard care

EXPERIMENTAL

Control Group: Patients will receive standard care. Anxiety will be assessed on day 1. They will be informed about a day 7 follow-up call and provided with VAS pain scales and complication checklists. On day 7, a phone interview will collect responses to the Comfort Scale, Patient Satisfaction Questionnaire, and State Anxiety Inventory, along with hospital readmission details.

Other: mobile application

Interventions

The aim is to evaluate whether a patient-centered mobile application with smartphone-based systematic follow-up assessment during the perioperative period can improve surgery-related anxiety, complications, comfort, and patient satisfaction compared to standard care. This thesis will be one of the pioneering studies in this field.

Also known as: standard care
The effect of a patient-oriented mobile applicationstandard care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a smartphone to install the mobile application No barriers to communication in Turkish Scheduled for surgery Willing to participate in the study Above 18 years of age Sufficient ability to use the mobile application

You may not qualify if:

  • Communication barriers Inability to use the mobile application Unwillingness to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bertocchi E, B. G. (2023, October 11). iColon, a Patient-focused Mobile Application for Perioperative Care in Colorectal Surgery: Results from 444 Patients. Journal of Telemedicine and Telecare, 11(1). Bertocchi, E., Barugola , G., Gentile, I., Zuppini, T., & Zamperini, M. (2021, November). iColon, a patient-focused mobile application for perioperative care in colorectal surgery: an observational, real-world study protocol. BMJ open, 11(11). Carlier, J. R.-G. (2021). Pain Evaluation after Day-Surgery Using a Mobile Phone Application. Anaesthesia, Critical Care & Pain Medicine, 40(3). Dönmez, E., Dolu, İ., & Yılmaz, Ş. (2022). VALIDITY AND RELIABILITY OF A QUESTIONNAIRE TO MEASURE THE PATIENT SATISFACTION WITH NURSING CARE QUALITY TURKISH VERSION. Asia Pacific Journal of Health Management, 17(2). Jaensson, M. D. (2017). Evaluation of Postoperative Recovery in Day Surgery Patients Using a Mobile Phone Application: a Multicentre Randomized Trial. British Journal of Anaesthesia, 119(5), s. 1030-1038. Ko, Y. H. (2021, March 21). The Development of a Mobile Application for Older Adults for Rehabilitation Instructions After Hip Fracture Surgery. Geriatric Orthopaedic Surgery & Rehabilitation, 12(2). Li, C. H. (2019). Monitoring of Home Recovery Using the 317-Nursing Mobile Application Following day-case Surgery in Children: Perspectives from both Nurses and Patients. NIH, 98(31). Morte, K., Marenco , C., Lammers, D., Bingham, J., Sohn, V., & Eckert, M. (2021). Utilization of Mobile Application Improves Perioperative Education and Patient Satisfaction in General Surgery Patients. American Journal of Surgery, 221(4), s. 788-792. Noel, W., Bosc, R., Jabbour, S., Keçiçyan, E., Hersant, B., & Meningaud, J.-P. M. (2017). Smartphone-Based Patient Education in Plastic Surgery. Annals of Plastic Surgery, 79(6), s. 529-531. Özyürek, H., & Göktaş, S. (2021). Acil ve Elektif Cerrahide Hastaların Anksiyete Düzeylerinin ve Hemşirelik Bakım Memnuniyetlerinin Değerlendirilmesi. Sağlık Bilimleri Üniversitesi Hemşirelik Dersgisi, 3(2), s. 83-92. Ponder, M. V.-Y. (2021). Mobile Health Application for Patients Undergoing Breast Cancer Surgery: Feasibility Study. JCO Oncology Practice, 17(9). Yeşilot, S. B., Çiftçi, H., & Yener, M. K. (2021). Lokal Anestezi Altında Lipom Eksizyonu Yapılan Bireylerde Stres Küpü ile Dikkati Başka Yöne Çekme Uygulamasının Ağrı ve Anksiyete Üzerine Etkisi: Randomize Kontrollü Deneysel Çalışma. Ege Tıp Dergisi, 60(3), 219-229. Özsoy, F., Yıldız, M., Gülücü, S., & Kulu, M. (2018). Doğum ağrısı ve bazı psikiyatrik özel-likler arasındaki ilişki. KSU Medical Journal, 13(2), 43-47.

    BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Experimental Group: Patients will receive information about the mobile app and install it for free. Preoperative education, pain monitoring, and complication tracking will be conducted via the app. Video consultations will be available for wound care. On surgery day, they will receive standard care. Anxiety will be assessed on postoperative day 1, and daily follow-ups will continue until day 7, when they will complete the Comfort Scale, Patient Satisfaction Questionnaire, and State Anxiety Inventory via the app. Control Group: Patients will receive standard care. Anxiety will be assessed on day 1. They will be informed about a day 7 follow-up call and provided with VAS pain scales and complication checklists. On day 7, a phone interview will collect responses to the Comfort Scale, Patient Satisfaction Questionnaire, and State Anxiety Inventory, along with hospital readmission details.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 24, 2025

Study Start

April 15, 2025

Primary Completion

September 16, 2025

Study Completion

December 20, 2025

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

The data of the study will be stored for 5 years.