Symptoms and General Pathology

All Conditions

Neoplasms

Mouth and Tooth Diseases

Digestive System Diseases

Behaviors and Mental Disorders

Rare Diseases

Cancer Pain

Pain

Head and Neck Neoplasms

Stomatitis

Mucositis

Mouth Neoplasms

Quality of Life

Oral Cancer

Laryngeal Cancer

Lip and Oral Cavity Cancer

Active high frequency TENS will be use for Active TENS.

Placebo TENS will be applied for one arm of the study

Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).

Transcutaneous Electrical Nerve Stimulation (TENS)

Jennifer E Lee, PhD

The overall goal of this study is to examine the effect of a single dose of TENS on mucositis pain and function secondary to head and neck radiation therapies. Oral mucositis is an extremely debilitating, unpreventable condition (inflammation, ulcers, bleeding in the mouth, nose, and throat) that causes significant pain, functional impairment, and diminished quality of life. Head and neck cancers pose specific challenges to effective pain management and past studies suggest the use of effective non-pharmacologic strategies such as TENS may be particularly beneficial for avoiding sources of acute and chronic pain, thereby improving quality of life. The investigators hypothesize that a single dose of TENS will decrease pain and improve function and quality of life in head and neck cancer patients. This project is particularly innovative because it is the first known study to examine the efficacy of TENS, an established safe, inexpensive and easy-to-use non-pharmacologic pain management intervention, for treating acute oral mucositis pain. The investigators research translates bench (animal model) science to human subjects using an interdisciplinary approach to pain management. Establishing whether TENS is effective for reducing mucositis pain is a critical first step toward establishing an effective, non-pharmacologic pain relief intervention for mucositis.

Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC)

The Influence of TENS on Mucositis Pain and Function in Head and Neck Cancer Patients: A Randomized and Placebo-Controlled Double Blind Clinical Trial

Participants rated 0-10 pain intensity in head/neck cancer area using one number (where their disease was located) by a vertical line on a horizontal 10-cm visual analog scale (VAS) from 0 "no pain" to 10 "worst possible pain." Possible scores ranged from 0-10 (10=worse pain). VAS was assessed two times each visit: (1) Pre-VAS: start of visit, (2) Post-VAS: end of the visit. The outcome measure was each person's change in pain: Pre-VAS minus Post-VAS, to create VAS change score. An average of all participants' VAS change score was calculated for each TENS condition (Active, Placebo, No TENS) and used as the dependent measure.

Jennifer E. Lee

Post Doctoral Research Fellow

Active high frequency TENS will be use for Active TENS.

Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).

Active TENS

Low Intensity TENS will be applied for one arm of the study

Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).

Low Intensity TENS

TENS unit in place but not turned on

Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).

No Treatment

All participants' characteristics, prior to first treatment

All Participants

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Jen Lee

Each participant received an Active TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Active TENS condition. Active TENS was delivered for 30 minutes at a frequency of 125Hz and a pulse duration of 100 2s on continuous mode output (calibrated using an oscilloscope before the study). Transcutaneous electrical nerve stimulation intensity was increased by the allocator until patients reported a ''maximally strong but comfortable sensation'' to ensure an analgesic effect.

Each participant received an Placebo TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Placebo TENS condition. Placebo TENS parameters were identical to active TENS (125 Hz, 100 2s). A novel, transient placebo TENS unit, previously tested and validated, was used. The intensity was increased until patients first felt ''any sensation at all (sensory threshold)'' in any electrode (ie, they did not have to reach sensory threshold in all electrodes). The placebo device then provided a current for 30 seconds and decreased gradually over 15 seconds to 0 output (ie, 45 seconds from the first sensory threshold). An indicator light remained on for the remainder of the visit so it appeared to the participant and outcomes assessor that the unit was still producing current.

Placebo TENS

Each participant received a No TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the No TENS condition. No TENS parameters were identical to active and placebo TENS, except that (1) the unit was never turned on and (2) participants were told that the unit was not on.

No TENS

The sample was adults (18 or greater) years old with oropharyngeal or laryngeal cancer.

Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS)

Active high frequency TENS will be used visit 1 Washout 6 days Placebo for visit 2- 7 days after visit 1 Washout for 6 days No tens visit 3- 7 days after visit 2

Order: Active, Placebo, No TENS

Placebo low frequency TENS will be used visit 1 Washout 6 days Active high intensity TENS for visit 2- 7 days after visit 1 Washout for 6 days No tens visit 3- 7 days after visit 2

Order: Placebo, Active, No TENS

No TENS will be used visit 1 Washout 6 days Active high intensity TENS for visit 2- 7 days after visit 1 Washout for 6 days Placebo Low Intensity TENS visit 3- 7 days after visit 2

Order: No TENS, Active, Placebo

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

In TENS group patients, 4 electrodes of the TENS device (2 on the front side: on the anterior right and left groin skin, 2 on the back side: on the right and left presacral skin) were placed 3-5 minutes before the biopsy procedure, and the application was started and TENS was applied throughout the procedure. continued. TENS was applied again for 30 minutes 2 hours after the procedure. Frequency of the TENS program applied in the conventional model: 100 Hz; pulse width: 150 μs; duration:30 minutes; The current intensity (amplitude: highest level 60 mA) is adjusted (according to individual tolerance by asking the patient) to create a tingling or pricking sensation that does not disturb the patient.Data were collected in three stages.

TENS application was not performed. Data were collected in three stages. The first (before biopsy) and second (during and after biopsy) stages were carried out face to face, and the third stage (after discharge) was conducted by telephone interview technique.

Research data; The data were collected by the researcher using face-to-face and telephone interview techniques using the "Personal Information Form", "Pain Evaluation Form", "TRUSG-PBx Complication Monitoring Form" and "Perianesthesia Comfort Scale", which evaluate the personal and disease-related characteristics of the patients.

In TENS group patients, 4 electrodes of the TENS device were placed 3-5 minutes before the biopsy procedure, and the application was started and TENS was applied throughout the procedure. continued. TENS was applied again for 30 minutes 2 hours after the procedure.

Transcuten Electriacal Nerve Stimulation

Prostate cancer is one of the most common types of malignancy in men. Transrectal Ultrasound Guided Prostate Biopsy (TRUSG-PBx) is considered the gold standard method. The present, Transrectal ultrasound guided prostate biopsy is considered the gold standard method in the diagnosis of prostate cancer. During the process, patients experience severe discomfort and pain, although anesthetics and analgesics are used. In addition to pharmacological methods, non-pharmacological methods are also used in the control of pain caused by diagnosis and treatment interventions. Transcutaneous Electrical Nerve Stimulation (TENS) is among the non-pharmacological methods and it is the most widely used electroanalgesia method. In this randomized controlled intervention research, the effect of TENS application will be evaluated on pain, complications and comfort level during and after the procedure in patients who underwent Transrectal Ultrasound-Guided Prostate Biopsy. Thanks to this research, it is thought that the pain level and complications will decrease and the comfort level will increase in patients who undergo TENS application.

The research will be carried out in Çukurova University Faculty of Medicine Balcalı Application and Research Hospital Urology Outpatient Clinic. The sample of the research will create volunteer patients, providing research criteria and made prostate biopsy in Urology Outpatient Clinic. Patients consisting of 2 groups as control and experimental (TENS applied) will be determined by randomization. In the power analysis calculated with statistical support, confidence interval of 95%, alpha value 0.05, beta value calculated with 80% power, a total of 80 patients will be included in the control and experimental group, including 40 patients each. The data will be collected by "Personal Information Form", "Pain Assessment Form", "TRUSG-PBx Complication Follow-up Form", "Perianesthesia Comfort Scale Form". The data obtained will be analyzed in SPSS (Statisticial Package for the Social Sciences) package program.

In this context, our research, a comparison will be made by evaluating the effect of TENS application on pain, complications and comfort, in patients who underwent transrectal ultrasound-guided prostate biopsy. These results, non-pharmacological methods will make great contributions to improving patient outcomes in diagnostic interventions.

Keywords: Pain, Nurse, Comfort, Prostate Biopsy and Complications, Transcutaneous Electrical Nerve Stimulation (TENS).

Prostate cancer is one of the most common types of malignancy in men. According to GLOBOCAN (Global cancer statistics) 2020 data, the age-standardized incidence rate of prostate cancer varies between 37.5-11.3 per hundred thousand in the world, depending on the development level of the countries, and it is seen to be 42.5 per hundred thousand in our country. It ranks second after lung cancer in terms of incidence in men in our country and in the world.

Prostate cancer screening aims to reduce mortality and morbidity by detecting prostate cancer at an early stage. In the diagnosis of prostate cancer, digital rectal examination (DRE), prostate specific antigen (PSA) value, transrectal ultrasonography (TRUSG) and biopsy are used.

Transrectal ultrasound-guided prostate biopsy (TRUSG-PBx) is currently considered the gold standard method in the diagnosis of prostate cancer.

In the TRUSG-guided biopsy procedure, patients are placed in the left lateral or lithotomy position, a needle-guided rectal probe is inserted into the anal canal with the help of lubricating gel, and the prostate tissue is monitored under ultrasound guidance and a biopsy is taken. The procedure takes approximately 20-30 minutes, and insertion and removal of the probe into the rectal area takes approximately 10-15 minutes in total.

TRUSG-PBx is a cost-effective, accessible invasive procedure that has undergone significant changes and developments over the years, is well tolerated, has minimally serious, undesirable side effects and complications, can be easily and quickly performed in outpatient conditions. However, although it is a safe method with a low complication rate, each patient must be carefully monitored because it is an invasive procedure. Complications frequently include hematuria, hematospermia, rectal bleeding, dysuria, urinary retention, hematochezia, erectile dysfunction, infection, prostatitis and pain. In most patients who will undergo transrectal biopsy, the possibility of the result being cancer and the psychological discomfort caused by the fact that the procedure will be performed rectally increase the pain.

Although prostate biopsy is thought to be well tolerated by patients, it appears to cause discomfort and pain in 65% to 90% of cases. Failure to recognize and deal with this problem not only affects patients' willingness to undergo the procedure again if necessary, but can also potentially lead to forgoing prostate evaluation or rejection of the procedure for fear of a painful invasive procedure. In addition, the importance of pain control has gradually increased due to prostate biopsy being performed on younger patients, biopsies being taken from more quadrants, and repeated prostate biopsies. Due to severe pain, the rate of tolerance of the procedure by the patient decreases, and this may lead to a decrease in the number of biopsy samples taken from the planned quadrant and a decrease in cancer detection rates. Therefore, it is extremely important to ensure pain control and increase patient tolerance and comfort in TRUSG-PBx.

The pain felt during the biopsy occurs for 2 reasons. The first is pain caused by stretching of the anal sphincter as the transrectal ultrasound probe enters the anus (passing the ultrasound probe through the anus, advancing it into the rectum, and manipulating it within the rectum). Especially before biopsy, periprostatic nerve blockade requires penetration into the rectum with a rectal probe before anesthesia, and this first penetration causes the patients' complaints. The second is the pain felt when the biopsy needle penetrates the prostate capsule and enters the prostatic stroma.

Pharmacological methods such as local anesthetics, peripheral nerve blockade, spinal and intravenous (IV) sedation applications have been used to reduce pain and discomfort, and results have been reported showing that these methods increase pain tolerance in the patient. The increasing use of active surveillance and the acceptance of prostate biopsy for prostate cancer management are very important to relieve or reduce patients' discomfort during biopsy and optimize satisfaction and comfort.

Although TRUSG-PBx is easy to perform and causes very low mortality, there is a need to develop new protocols for analgesia before the procedure to reduce the discomfort and pain that patients may feel.

Nurses should also apply non-pharmacological methods to reduce the consumption of analgesic drugs or increase their effect by providing adequate analgesia. Nurses, who have a key role in the pain management team, should do what is necessary about pain preventive approaches and pain control methods at this stage.

Non-pharmacological methods are important in providing comfort and a feeling of control, improving functionality and quality of life, and reducing pain and anxiety.

TRUSG-PBx is a challenging diagnostic procedural intervention due to pain and fear for patients. For this reason, non-pharmacological methods should be used and pharmacological methods should be integrated into nursing practices in order to tolerate the procedure by patients and ensure effective pain control.

Among the non-pharmacological methods that can be used safely in acute painful interventions, Transcutaneous Electrical Nerve Stimulation (TENS) is an effective electroanalgesia method. This method is a method of applying controlled low-voltage electrical current to the nervous system through electrodes placed on the skin. The pain-relieving effect of TENS is explained in two ways. The first is that TENS stimulates the sensory A fibers with high frequency stimulation, and the impulses of this stimulation cover the path to the brain and close the door to the passage of pain. Secondly, it affects the perception of pain by initiating the release of natural opioids in the body. It is widely used in acute and chronic pain. TENS is an analgesia method requested by the specialist doctor. How TENS will be applied to which patient, its parameters, application area and duration are determined by the doctor, and it requires the cooperation of a nurse trained in TENS (from a physiotherapy or algology specialist in TENS application) and the doctor. Many studies in this field show that TENS reduces pain.

Although there are many evidence-based studies in the literature on pharmacological methods that reduce pain in TRUSG-PBx, the number of studies on non-pharmacological methods is quite limited.

Our clinical examinations show that non-pharmacological methods are used very rarely in TRUSG-PBx, there is no protocol to reduce pain during and after biopsy, and nurses do not apply TENS. Additionally, no studies have been found in the literature regarding the effect of TENS application on pain, complications and comfort during and after TRUSG-PBx. This study will guide nurses in using and developing non-pharmacological methods in clinics, choosing the appropriate ones for patients with their positive and negative aspects, evaluating their effectiveness, contributing to the professional and independent roles of the nursing profession, increasing the quality of care and providing comfort and satisfaction, thereby increasing the feeling of professional satisfaction. It is thought that it will increase. In addition, it will contribute to the effective application of TENS, which is a simple, cheap and effective method that nurses, who are responsible for patient follow-up and treatment, provide direction and provide uninterrupted health services, have the authority to apply together with the physician, and will guide the development of non-pharmacological analgesia applications. It is thought that nonpharmacological methods will improve patient outcomes in the control of procedural pain resulting from diagnostic interventions.

Purpose of the research:

This study was conducted to determine the effect of TENS on pain, comfort level and complications in patients who underwent transrectal ultrasound-guided prostate biopsy.

This study was conducted as a two-group randomized controlled intervention study to determine the effect of TENS application on pain, complications and comfort in patients undergoing transrectal ultrasound-guided prostate biopsy (TRUSG-PBx).

The Effect of TENS on Pain, Complications and Comfort in Patients Who Had Prostate Biopsy With Transrectal Ultrasound

The Effect of Transcute Electrical Nerve Stimulation On Pain, Complication and Comfort in Patients Who Undergo Prostate Biopsy With Transrectal Ultrasound

The scale consists of 24 items and questions the individual's feelings, thoughts and feelings before and after the surgical procedure. Each item in the scale is a Likert type with a score ranging from 1 to 6 points, from "strongly disagree" to "strongly agree". It consists of positive and negative substances. 12 of the items are positive and 12 are negative.Negative statements are reversed when scoring.Accordingly, in positive items, a high score (6) indicates high comfort, a low score (1) indicates low comfort, and in negative items, a low score (1) indicates high comfort and a high score (6) indicates low comfort. In the evaluation of the scale; The resulting negative scores are reverse coded and summed with positive scores. The highest score that can be obtained from the scale is 144 and the lowest score is 24. As a result, as the score increases, comfort increases.

The scale used in the first part of this form, which is intended to evaluate pain severity, is the Numerical Pain Scale (NPS). On this scale, it starts with absence of pain (0) and reaches the level of unbearable pain (10).According to the determined measurement times of the patients \[T1: At the beginning of the biopsy/while the ultrasound probe is being placed (NPS-1), T2: During the biopsy/5 minutes after the ultrasound probe is placed (NPS-2), T3: At the end of the biopsy/while the ultrasound probe is being removed (NPS-3). , T4: 1 hour after the end of the biopsy (NPS-4), T5: 2 hours after the end of the biopsy (NPS-5), T6: 2.5 hours after the end of the biopsy (NPS-6), T7: During the first urination after the biopsy (NPS-6). -7), T8: 6 hours after the end of the biopsy (NPS-8), T9: 24 hours after the end of the biopsy (NPS-9)\]. The second part of the pain evaluation form includes information about the analgesic medication used in the first 6 and 24 hours.

Comparison of complications of patients according to time Prepared by the researchers in line with the literature, the first part of TKIF, prepared by the researchers in line with the literature, aims to determine bleeding during biopsy (rectal bleeding, bleeding from the urethra) and bleeding in the first urine after biopsy, and the second part / after discharge (at home) aims to determine complications that may develop after biopsy. 6 items are included (hematuria, hematospermia, rectal bleeding, dysuria, anal pain, urinary retention).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC)	NCT01194466	Head Cancer Neck Cancer Pain	Transcutaneous ...	18 Years - 90 Years	University of Iowa
The Effect of TENS on Pain, Complications and Comfort in Patients Who Had Prostate Biopsy With Transrectal Ultrasound	NCT06414421	Prostate Cancer...	Transcuten Elec...	40 Years -	Cukurova University

Spots Global Cancer Trial Database for transcutaneous electrical nerve stimulation (tens)