The Effect of E-Mobile and Written Education

Sponsor

Cukurova University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05481541

Collaborator

(none)

Enrollment

Locations

Arms

11.2

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Bening's Prostate Hyperplasia (BPH), which is closely related to aging, is one of the most common diseases in the world. Although it is not a life-threatening condition, lower urinary tract symptoms (LUTS) are seen in many patients, which disrupts their daily activities, sleep patterns, and quality of life of the patients. Examination of changes in sleep and quality of life after transurethral resection of the prostate (TUR-P) in patients with LUTS due to BPH and planning training according to their needs will positively affect the lives of these patients. It is very important for nurses to provide individual training and counseling by making use of innovative technology to ensure that patients manage the surgical process in a healthy way and cope with possible complications. This thesis study was planned as a three-group randomized controlled experimental study in order to determine the effect of e-mobile training and counseling on quality of life and sleep in patients who underwent TUR-P to manage the operative process and cope with possible complications.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life Sleep Education Counseling Nursing	Other: written education	N/A

Detailed Description

This thesis study aims to determine the effect of e-mobile training and counseling on quality of life and sleep in patients who underwent TUR-P for BPH, to manage the operation process and to cope with possible complications, and to determine the effectiveness of the written training given to the patients, the control group and the e-mobile application designed for comparasion.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effect of E-Mobile and Written Education on Quality of Life and Sleep After Transurethral Surgery

Actual Study Start Date :

Mar 10, 2022

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Feb 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: written education group Experimental: The Effect of E-Mobile and Written Education on Quality of Life and Sleep in Patients with Transurethral Prostate Resection According to the randomization, preoperative training will be applied to the patients in the e-mobile training/written training group. The training will be administered by the principal researcher using the face-to-face interview technique.	Other: written education Other names: Written/E-Mobile training The study was conducted as a three-group randomized controlled trial to examine the effect of written/mobile education on the quality of life and sleep of patients undergoing transurethral resection of the prostate. Written education was applied to the first group and mobile education was applied to the second group. Group 3 formed the control group. Other Names: E-Mobile education
Active Comparator: Mobile education application group Experimental: The Effect of E-Mobile and Written Education on Quality of Life and Sleep in Patients with Transurethral Prostate Resection According to the randomization, preoperative written/mobile education will be applied to the patients in the e-mobile education/written education group. The training will be given by the principal researcher using the face-to-face interview technique.	Other: written education Other names: Written/E-Mobile training The study was conducted as a three-group randomized controlled trial to examine the effect of written/mobile education on the quality of life and sleep of patients undergoing transurethral resection of the prostate. Written education was applied to the first group and mobile education was applied to the second group. Group 3 formed the control group. Other Names: E-Mobile education
No Intervention: Control (standard care) group Experimental: The Effect of E-Mobile and Written Education on Quality of Life and Sleep in Patients with Transurethral Prostate Resection Routine post-operative care will be given to the control group without any intervention and data collection tools will be applied at the same time as the experimental group, twice at 30-minute intervals.

Arm

Intervention/Treatment

Experimental: written education group

Experimental: The Effect of E-Mobile and Written Education on Quality of Life and Sleep in Patients with Transurethral Prostate Resection According to the randomization, preoperative training will be applied to the patients in the e-mobile training/written training group. The training will be administered by the principal researcher using the face-to-face interview technique.

Other: written education

Other names: Written/E-Mobile training The study was conducted as a three-group randomized controlled trial to examine the effect of written/mobile education on the quality of life and sleep of patients undergoing transurethral resection of the prostate. Written education was applied to the first group and mobile education was applied to the second group. Group 3 formed the control group.

Other Names:

E-Mobile education

Active Comparator: Mobile education application group

Experimental: The Effect of E-Mobile and Written Education on Quality of Life and Sleep in Patients with Transurethral Prostate Resection According to the randomization, preoperative written/mobile education will be applied to the patients in the e-mobile education/written education group. The training will be given by the principal researcher using the face-to-face interview technique.

Other: written education

Other Names:

E-Mobile education

No Intervention: Control (standard care) group

Experimental: The Effect of E-Mobile and Written Education on Quality of Life and Sleep in Patients with Transurethral Prostate Resection Routine post-operative care will be given to the control group without any intervention and data collection tools will be applied at the same time as the experimental group, twice at 30-minute intervals.

Outcome Measures

Primary Outcome Measures

1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time Frame: 0 days-3 month] [Time Frame:0-3 months]
Change in sleep and quality of life before and after training

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion criteria:

Being literate, not having communication, hearing and visual impairments, not having any psychiatric disorders, not having sleep apnea, using a smartphone for at least 1 year in the experimental group,

Exclusion Criteria:

-The patient's refusal to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cukurova University	Adana	Eyalet/Yerleşke	Turkey	0101011
2	Cukurova University	Adana		Turkey	0101011

Sponsors and Collaborators

Cukurova University

Investigators

Study Chair: Sevban Arslan, PhD, Cukurova Universty Faculty of Health Sciences Adana, Turkey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seyma Yurtseven, Principal Investigator, Cukurova University

ClinicalTrials.gov Identifier:

NCT05481541

Other Study ID Numbers:

0000-0003-2378-682X

First Posted:

Aug 1, 2022

Last Update Posted:

Aug 1, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 1, 2022