NCT05481541

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started May 2021

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

March 30, 2022

Last Update Submit

October 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time Frame: 0 days-3 month]

    Change in sleep and quality of life before and after training

    Time Frame:0-3 months

Study Arms (3)

written education group

EXPERIMENTAL

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

Mobile education application group

ACTIVE COMPARATOR

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

Control (standard care) group

NO INTERVENTION

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.

Interventions

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.

Also known as: E-Mobile education
Mobile education application groupwritten education group

Eligibility Criteria

Age18 Years - 85 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsObligation of male gender due to the presence of prostate
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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,

You may not qualify if:

  • The patient's refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cukurova University

Adana, Eyalet/Yerleşke, 0101011, Turkey (Türkiye)

Location

Cukurova University

Adana, 0101011, Turkey (Türkiye)

Location

Study Officials

  • Sevban Arslan, PhD

    Cukurova Universty Faculty of Health Sciences Adana, Turkey

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2022

First Posted

August 1, 2022

Study Start

May 1, 2021

Primary Completion

October 15, 2021

Study Completion

October 15, 2022

Last Updated

October 3, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations