- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06456632
The Effect of Su Jok Therapy on Postoperative Pain, Anxiety and Patient Satisfaction in Patients With BPH (SuJokTherapy)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Group not receiving Su Jok Therapy
|
|
|
Experimental: Intervention Group
Group receiving Su jok therapy
|
Su Jok Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From preoperative to 8 hours postoperatively
|
|
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.
|
Preoperative and 8th hour after surgery
|
|
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).
|
8th hour after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA24/89 (Other Grant/Funding Number: Baskent University Institutional Ethics Committee)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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