Quality of LifeNCT05481541
The Effect of E-Mobile and Written Education
A study testing written education in people with Quality of Life and Sleep, run by Cukurova University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Quality of Life, Sleep, Education
- What is being tested?
- written education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2021to 15 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- -The patient's refusal to participate in the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Cukurova University
Adana, Eyalet/Yerleşke, 0101011
Cukurova University
Adana, 0101011
About this study
Official title: The Effect of E-Mobile and Written Education on Quality of Life and Sleep After Transurethral Surgery
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.
Read the 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.
- Conditions
- Quality of Life, Sleep, Education, Counseling, Nursing
- Being tested
- written education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
written educationOther
Also called E-Mobile 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time Frame:0-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 May 2021
- Primary completion15 Oct 2021
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Yurtseven, Cukurova University
- Investigators
- Sevban Arslan, PhD, Study chair, Cukurova Universty Faculty of Health Sciences Adana, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481541
- Sponsor's protocol ID
- 0000-0003-2378-682X
- Status last verified
- Oct 2023
- First submitted
- 30 Mar 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of E-Mobile and Written Education on Quality of Life and Sleep After Transurethral Surgery
- ClinicalTrials.gov ID
- NCT05481541
- Acronym / sponsor ID
- 0000-0003-2378-682X
- Conditions
- Quality of Life, Sleep, Education, Counseling, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| written education group | Experimental | Other: written educationExperimental: 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. |
| Mobile education application group | Active comparator | Other: written educationExperimental: 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. |
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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,
Key exclusion criteria (1 listed)
- -The patient's refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| written educationAlso: E-Mobile educationOther 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 | Mobile education application group, written education group |
Primary outcome
1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time Frame: 0 days-3 month]
Time frame: Time Frame:0-3 months
Change in sleep and quality of life before and after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevban Arslan, PhD study chair
Cukurova Universty Faculty of Health Sciences Adana, Turkey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing written education in people with Quality of Life and Sleep, run by Cukurova University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time Frame: 0 days-3 month] (time frame: Time Frame:0-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023; AzTrials last refreshed its copy on 3 Nov 2026.