Prostatic HyperplasiaNCT06699563
The Effect of Using a Motivation Card on Pain and Number of Walking Steps After Prostate Surgery
A study testing Mobilization Motivation Card in people with Prostatic Hyperplasia, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical study is to evaluate the effect of using motivational cards on pain and step counts in patients who underwent open prostate surgery due to benign prostatic hyperplasia.The main hypotheses are: H1: Patients who use motivation cards during mobilization after open prostate surgery have lower… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Mobilization Motivation Card
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jan 2024to 30 Jul 2025
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hospitalized in the ENT-Urology Clinic
- Those aged 18 and over
- Those who will undergo elective surgery
- Volunteer to participate in the study
- Post-surgical follow-up will be done in the service.
- Those who will undergo general anesthesia
- No mental problems
- Patients who had no vision, hearing or speech problems were included.
Who cannot join
- Those who will undergo emergency and unplanned surgical intervention
- Laparoscopic surgery was performed
- Taken to the intensive care unit after surgery
- Those who will not undergo general anesthesia
- Having mental problems
- Patients with vision, hearing and speech problems were not included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekirdağ Dr. İsmail Fehmi Cumalıoğlu City Hospital
Tekirdağ, Tekirdağ, 59000
About this study
Official title: The Effect of Using Motivational Cards on Pain Level and Number of Steps in Mobilization of Patients After Open Prostate Surgery
The purpose of this clinical study is to evaluate the effect of using motivational cards on pain and step counts in patients who underwent open prostate surgery due to benign prostatic hyperplasia.The main hypotheses are:
H1: Patients who use motivation cards during mobilization after open prostate surgery have lower pain levels than those who do not. H2: Patients who used motivation cards for mobilization after open prostate surgery had a higher number of steps than those who did not use them. After the surgery, patients were asked to walk with a pedometer. A mobilization motivation card was used in the study group.
Read the detailed description
The group distribution of the patients was made using the Random Allocation Software (Version 2.0.0) program and the patients were divided into two groups: the study group and the control group.
The patients were visited by the researcher in their rooms on the morning of the day they were scheduled for surgery, and the purpose of the study was explained to the patients. Verbal and written consent was obtained from those who agreed to participate in the study, and it was explained to the patients that they would be visited again at their bedsides the day after surgery.
The Visual Pain Scale was created to assess the severity of pain. A score of '0' at the left end of the line indicates no pain, and a score of '10' at the right end indicates unbearable pain. In this study, patients were asked to mark the severity of the pain they were experiencing on a scale. The research nurse visited the patient in the service rooms before they were transferred to the operating room to make the first assessment in the study group, and the purpose of the study was explained to the patient. Patient introduction form, pedometer and mobilization motivation card were introduced to the patient. The patient was informed that they would be visited at 10:00 a.m. on the first day after the surgery to mobilize the patient. On the morning of the first day after surgery, the patient's pain status was determined with the Visual Pain Scale. The patient's vital signs were checked and the pedometer was placed on the lumbar region. The patient was mobilized according to the mobilization stage. The number of steps after the first mobilization was recorded on the mobilization motivation card and the card was hung at the bedside. The researcher nurse was informed that he would be visited again in 1 hour and these stages were repeated 3 times.
In the control group, the first evaluation was made by the researcher nurse. Patient introduction form, pedometer were introduced to the patient. On the morning of the first day after surgery, the patient's pain status was determined with the Visual Pain Scale. The patient's vital signs were checked and the pedometer was placed on the lumbar region. The patient was mobilized according to the mobilization stage. The number of steps after the first mobilization was recorded on the mobilization motivation card but was not given to the patient. The researcher nurse informed that he would be visited again in 1 hour and these stages were repeated 3 times.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Mobilization Motivation Card
- Keywords
- Walking, Pain, Motivation
- Medical subject headings
- Prostatic Hyperplasia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization Motivation CardBehavioural
On the morning of the surgery, the Mobilization Motivation Card and Pedometer will be introduced and the patient will be informed. On the morning of the first postoperative day, before the patient's first mobilization, pain assessment will be made with the Visual Analog Scale (VAS), and the Mobilization Motivation Card will be hung at the bedside during the day and will help increase the patient's participation in mobilization. Later, after a pedometer is attached to the patient's waist, the patient will be mobilized.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental (with Card) | Experimental | In this procedure, patients used a pedometer and mobilization motivation card during their mobilization on the first postoperative day. Receives: Behavioral: Mobilization Motivation Card |
| No Intervention: Standard (No Card) | No intervention | In this procedure, patients used a pedometer during their mobilization on the first postoperative day. They did not use a mobilization motivation card. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps after surgery
Before mobilization, the number of steps taken will be tracked via a pedometer placed on the patient's waist, and after mobilization, the pedometer will be taken back from the patient. The number of steps taken will be recorded by the nurse.
Measured: 12 months
Secondary outcomes (1)
Pain before and after mobilization
Before mobilization, patients will be assessed for pain using a visual analog pain scale. To assess pain, patients are asked to rate their pain level on a scale ranging from 0 - "No pain" to 10 - "Unbearable pain".
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start29 Jan 2024
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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
- Model description
- The research will be conducted using randomized controlled, experimental type and single-blind research methods. For this purpose, after the data are collected, they will be coded as A and B groups, so the researcher who will make the research statistics will analyze the data without knowing the study and control groups. Randomization method will be used to determine the groups. For this, the patients who meet the study criteria and volunteer will be assigned to the groups using the randomization program 'Random Allocation Software 2.0' according to the order of hospitalization.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seher Ünver, Trakya University
- Investigators
- Seher Unver, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699563
- Sponsor's protocol ID
- 2023/442
- Status last verified
- Jul 2025
- First submitted
- 19 Nov 2024
- Last updated
- 6 Aug 2025
- 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 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Motivational Cards on Pain Level and Number of Steps in Mobilization of Patients After Open Prostate Surgery
- ClinicalTrials.gov ID
- NCT06699563
- Acronym / sponsor ID
- 2023/442
- Conditions
- Prostatic Hyperplasia
- Keywords
- Walking, Pain, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 21 Nov 2024 (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.
The purpose of this clinical study is to evaluate the effect of using motivational cards on pain and step counts in patients who underwent open prostate surgery due to benign prostatic hyperplasia.The main hypotheses are:
H1: Patients who use motivation cards during mobilization after open prostate surgery have lower pain levels than those who do not. H2: Patients who used motivation cards for mobilization after open prostate surgery had a higher number of steps than those who did not use them. After the surgery, patients were asked to walk with a pedometer. A mobilization motivation card was used in the study group.
Detailed description
The group distribution of the patients was made using the Random Allocation Software (Version 2.0.0) program and the patients were divided into two groups: the study group and the control group.
The patients were visited by the researcher in their rooms on the morning of the day they were scheduled for surgery, and the purpose of the study was explained to the patients. Verbal and written consent was obtained from those who agreed to participate in the study, and it was explained to the patients that they would be visited again at their bedsides the day after surgery.
The Visual Pain Scale was created to assess the severity of pain. A score of '0' at the left end of the line indicates no pain, and a score of '10' at the right end indicates unbearable pain. In this study, patients were asked to mark the severity of the pain they were experiencing on a scale. The research nurse visited the patient in the service rooms before they were transferred to the operating room to make the first assessment in the study group, and the purpose of the study was explained to the patient. Patient introduction form, pedometer and mobilization motivation card were introduced to the patient. The patient was informed that they would be visited at 10:00 a.m. on the first day after the surgery to mobilize the patient. On the morning of the first day after surgery, the patient's pain status was determined with the Visual Pain Scale. The patient's vital signs were checked and the pedometer was placed on the lumbar region. The patient was mobilized according to the mobilization stage. The number of steps after the first mobilization was recorded on the mobilization motivation card and the card was hung at the bedside. The researcher nurse was informed that he would be visited again in 1 hour and these stages were repeated 3 times.
In the control group, the first evaluation was made by the researcher nurse. Patient introduction form, pedometer were introduced to the patient. On the morning of the first day after surgery, the patient's pain status was determined with the Visual Pain Scale. The patient's vital signs were checked and the pedometer was placed on the lumbar region. The patient was mobilized according to the mobilization stage. The number of steps after the first mobilization was recorded on the mobilization motivation card but was not given to the patient. The researcher nurse informed that he would be visited again in 1 hour and these stages were repeated 3 times.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research will be conducted using randomized controlled, experimental type and single-blind research methods. For this purpose, after the data are collected, they will be coded as A and B groups, so the researcher who will make the research statistics will analyze the data without knowing the study and control groups. Randomization method will be used to determine the groups. For this, the patients who meet the study criteria and volunteer will be assigned to the groups using the randomization program 'Random Allocation Software 2.0' according to the order of hospitalization.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental (with Card) | Experimental | Behavioral: Mobilization Motivation CardIn this procedure, patients used a pedometer and mobilization motivation card during their mobilization on the first postoperative day. |
| No Intervention: Standard (No Card) | No intervention | –In this procedure, patients used a pedometer during their mobilization on the first postoperative day. They did not use a mobilization motivation card. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hospitalized in the ENT-Urology Clinic
- Those aged 18 and over
- Those who will undergo elective surgery
- Volunteer to participate in the study
- Post-surgical follow-up will be done in the service.
Key exclusion criteria (6 listed)
- Those who will undergo emergency and unplanned surgical intervention
- Laparoscopic surgery was performed
- Taken to the intensive care unit after surgery
- Those who will not undergo general anesthesia
- Having mental problems
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 |
|---|---|---|
| Mobilization Motivation CardOn the morning of the surgery, the Mobilization Motivation Card and Pedometer will be introduced and the patient will be informed. On the morning of the first postoperative day, before the patient's first mobilization, pain assessment will be made with the Visual Analog Scale (VAS), and the Mobilization Motivation Card will be hung at the bedside during the day and will help increase the patient's participation in mobilization. Later, after a pedometer is attached to the patient's waist, the patient will be mobilized. | Behavioural | Experimental: Experimental (with Card) |
Primary outcome
Number of steps after surgery
Time frame: 12 months
Before mobilization, the number of steps taken will be tracked via a pedometer placed on the patient's waist, and after mobilization, the pedometer will be taken back from the patient. The number of steps taken will be recorded by the nurse.
1 secondary outcome
Pain before and after mobilization
Time frame: 12 months
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 6 Aug 2025.
- 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.
Seher Unver principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization Motivation Card in people with Prostatic Hyperplasia, run by Trakya University at 1 site 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 8 inclusion and 6 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 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of steps after surgery (time frame: 12 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 6 Aug 2025.