Transurethral Resection (TUR) SyndromeSuJokTherapyNCT06456632
The Effect of Su Jok Therapy on Postoperative Pain, Anxiety and Patient Satisfaction in Patients With BPH
A study testing Intervention Su Jok Therapy in people with Transurethral Resection (TUR) Syndrome, run by Baskent University.
Trial summary
This study is the first nursing study in the field of urology to examine the effect of Su Jok Therapy on postoperative pain, anxiety and patient satisfaction in patients who underwent Transurethral Resection of the Prostate with a diagnosis of BPH and is thought to make an important contribution to evidence-based… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transurethral Resection (TUR) Syndrome
- What is being tested?
- Intervention Su Jok Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older diagnosed with BPH,
- First time undergoing TUR-P surgery,
- Does not have any cognitive, affective and verbal communication problems that prevent understanding of the information given and expressing the pain and anxiety correctly,
- Patients who volunteered to participate in the study
Who cannot join
- Those who have loss of sensation, amputation, injury, wound, active burn, fungal disease, etc. in their hands that will prevent them from practicing,
- HbA1c value in patients diagnosed with diabetes mellitus: 6.5% and above
- Using any complementary and integrative health practice in the last 3 months,
- Patients who do not speak Turkish, have hearing problems, language problems
About this study
Official title: The Effect of Su Jok Therapy on Postoperative Pain, Anxiety and Patient Satisfaction in Benign Prostatic Hyperplasia (BPH) Patients With Transurethral Prostate Resection (TUR-P): A Randomized Controlled Study
This study is the first nursing study in the field of urology to examine the effect of Su Jok Therapy on postoperative pain, anxiety and patient satisfaction in patients who underwent Transurethral Resection of the Prostate with a diagnosis of BPH and is thought to make an important contribution to evidence-based nursing practices. In line with the results obtained from the study, it is expected that the anxiety levels of patients planned to apply Su Jok therapy will be reduced, pain levels will be reduced, and patient satisfaction will increase.
Read the detailed description
Considering the literature, it is seen that the number of studies examining the effects of integrative methods used in symptom management such as Su Jok Therapy on postoperative pain, anxiety and patient satisfaction are high and have positive effects as a result. Still, there are a limited number of studies on the effects of Su Jok Therapy on postoperative pain and anxiety in the surgical field. This study is thought to make an important contribution to evidence-based nursing practices as it is the first nursing study in the field of urology to examine the effect of Su Jok Therapy on postoperative pain, anxiety level and patient satisfaction in patients undergoing transurethral resection of the prostate (TUR-P) with a diagnosis of BPH. In line with the results obtained from the study, it is planned to reduce the anxiety and pain levels of patients who are planned to apply Su Jok therapy and to increase patient satisfaction. In this study, it is aimed to determine the effect of Su Jok Therapy on postoperative pain, anxiety and patient satisfaction in patients diagnosed with BPH who underwent Transurethral Resection of Prostate (TUR-P).
Research Hypotheses:
H0-1: Su Jok therapy is not effective in reducing postoperative pain level in patients undergoing TUR-P.
H1-1: Su Jok therapy is effective in reducing postoperative pain level in patients undergoing TUR-P.
H0-2: Su Jok therapy is not effective in reducing anxiety level in patients undergoing TUR-P.
H1-2: Su Jok therapy is effective in reducing anxiety level in patients undergoing TUR-P.
H0-3: Su Jok therapy is not effective in increasing patient satisfaction in patients undergoing TUR-P.
H1-3: Su Jok therapy is effective in increasing patient satisfaction in patients undergoing TUR-P.
The population of this study will consist of patients who applied to the Urology Outpatient Clinic of Başkent University Ankara Hospital and were planned to undergo Transurethral Prostate Resection for the first time with the diagnosis of BPH.
According to hospital records, 52 patients diagnosed with BPH underwent TUR-P in the last year. The sample size of the study was calculated by a statistical expert using a sample size calculation program (G*Power version 3.1.9.4). The minimum sample size required for the study was planned to include at least 52 patients (26 intervention, 26 control) to be approximately equally distributed in the groups that will provide 80% test power at 95% confidence level, with an effect size of 0.80 and Cohen's large effect size of 0.80 for "One-Way Analysis of Variance" when the parametric test assumptions of "Whether there is a difference between more than two groups" are met, and "Kruskal Wallis Test" when not met.
- Conditions
- Transurethral Resection (TUR) Syndrome
- Being tested
- Intervention Su Jok Therapy
- Keywords
- Su jok therapy, Pain, Anxiety, Patient Satisfaction, Nursing
- Medical subject headings
- Syndrome, Pain, Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Su Jok TherapyOther
Su Jok Therapy
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Group not receiving Su Jok Therapy |
| Intervention Group | Experimental | Group receiving Su jok therapy Receives: Other: Intervention Su Jok Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Pain Assessment
Patient's pain will be assessed. The Visual Analogue Scale (VAS) will be used to assess pain.The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
Measured: From preoperative to 8 hours postoperatively
Anxiety
Patient's anxiety will be assessed. The State Anxiety Inventory (SAI) will be used to assess anxiety. The State Anxiety Inventory (SAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress. its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety.
Measured: Preoperative and 8th hour after surgery
Patient satisfaction
Patient satisfaction will be assessed. Visual Analog Patient Satisfaction Scale will be used to evaluate patient satisfaction.This scale ranges from 0 (not satisfied at all) to 10 (very satisfied).
Measured: 8th hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transurethral Resection (TUR) SyndromeStudies 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
- Intervention and Control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456632
- Sponsor's protocol ID
- KA24/89
- Other IDs
- KA24/89
- Acronym
- SuJokTherapy
- Status last verified
- Jun 2024
- First submitted
- 30 May 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Su Jok Therapy on Postoperative Pain, Anxiety and Patient Satisfaction in Benign Prostatic Hyperplasia (BPH) Patients With Transurethral Prostate Resection (TUR-P): A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06456632
- Acronym / sponsor ID
- SuJokTherapy / KA24/89
- Conditions
- Transurethral Resection (TUR) Syndrome
- Keywords
- Su jok therapy, Pain, Anxiety, Patient Satisfaction, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 13 Jun 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.
This study is the first nursing study in the field of urology to examine the effect of Su Jok Therapy on postoperative pain, anxiety and patient satisfaction in patients who underwent Transurethral Resection of the Prostate with a diagnosis of BPH and is thought to make an important contribution to evidence-based nursing practices. In line with the results obtained from the study, it is expected that the anxiety levels of patients planned to apply Su Jok therapy will be reduced, pain levels will be reduced, and patient satisfaction will increase.
Detailed description
Considering the literature, it is seen that the number of studies examining the effects of integrative methods used in symptom management such as Su Jok Therapy on postoperative pain, anxiety and patient satisfaction are high and have positive effects as a result. Still, there are a limited number of studies on the effects of Su Jok Therapy on postoperative pain and anxiety in the surgical field. This study is thought to make an important contribution to evidence-based nursing practices as it is the first nursing study in the field of urology to examine the effect of Su Jok Therapy on postoperative pain, anxiety level and patient satisfaction in patients undergoing transurethral resection of the prostate (TUR-P) with a diagnosis of BPH. In line with the results obtained from the study, it is planned to reduce the anxiety and pain levels of patients who are planned to apply Su Jok therapy and to increase patient satisfaction. In this study, it is aimed to determine the effect of Su Jok Therapy on postoperative pain, anxiety and patient satisfaction in patients diagnosed with BPH who underwent Transurethral Resection of Prostate (TUR-P).
Research Hypotheses:
H0-1: Su Jok therapy is not effective in reducing postoperative pain level in patients undergoing TUR-P.
H1-1: Su Jok therapy is effective in reducing postoperative pain level in patients undergoing TUR-P.
H0-2: Su Jok therapy is not effective in reducing anxiety level in patients undergoing TUR-P.
H1-2: Su Jok therapy is effective in reducing anxiety level in patients undergoing TUR-P.
H0-3: Su Jok therapy is not effective in increasing patient satisfaction in patients undergoing TUR-P.
H1-3: Su Jok therapy is effective in increasing patient satisfaction in patients undergoing TUR-P.
The population of this study will consist of patients who applied to the Urology Outpatient Clinic of Başkent University Ankara Hospital and were planned to undergo Transurethral Prostate Resection for the first time with the diagnosis of BPH.
According to hospital records, 52 patients diagnosed with BPH underwent TUR-P in the last year. The sample size of the study was calculated by a statistical expert using a sample size calculation program (G*Power version 3.1.9.4). The minimum sample size required for the study was planned to include at least 52 patients (26 intervention, 26 control) to be approximately equally distributed in the groups that will provide 80% test power at 95% confidence level, with an effect size of 0.80 and Cohen's large effect size of 0.80 for "One-Way Analysis of Variance" when the parametric test assumptions of "Whether there is a difference between more than two groups" are met, and "Kruskal Wallis Test" when not met.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention and Control group
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Group not receiving Su Jok Therapy |
| Intervention Group | Experimental | Other: Intervention Su Jok TherapyGroup receiving Su jok therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older diagnosed with BPH,
- First time undergoing TUR-P surgery,
- Does not have any cognitive, affective and verbal communication problems that prevent understanding of the information given and expressing the pain and anxiety correctly,
- Patients who volunteered to participate in the study
Key exclusion criteria (4 listed)
- Those who have loss of sensation, amputation, injury, wound, active burn, fungal disease, etc. in their hands that will prevent them from practicing,
- HbA1c value in patients diagnosed with diabetes mellitus: 6.5% and above
- Using any complementary and integrative health practice in the last 3 months,
- Patients who do not speak Turkish, have hearing problems, language 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 |
|---|---|---|
| Intervention Su Jok TherapySu Jok Therapy | Other | Intervention Group |
Primary outcome
Patient Pain Assessment
Time frame: From preoperative to 8 hours postoperatively
Patient's pain will be assessed. The Visual Analogue Scale (VAS) will be used to assess pain.The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
Anxiety
Time frame: Preoperative and 8th hour after surgery
Patient's anxiety will be assessed. The State Anxiety Inventory (SAI) will be used to assess anxiety. The State Anxiety Inventory (SAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress. its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety.
Patient satisfaction
Time frame: 8th hour after surgery
Patient satisfaction will be assessed. Visual Analog Patient Satisfaction Scale will be used to evaluate patient satisfaction.This scale ranges from 0 (not satisfied at all) to 10 (very satisfied).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Su Jok Therapy in people with Transurethral Resection (TUR) Syndrome, run by Baskent University.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Patient Pain Assessment (time frame: From preoperative to 8 hours postoperatively). The study lists 3 primary outcomes in all. 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 13 Jun 2024.