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

NCT06414421 | Completed

• 1 other identifier: CukurovaUSFırat
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prostate Cancer XXX

Keywords

Transcutaneous Electrical Nerve Stimulation (TENS)

Outcome Measures

Primary Outcomes (1)

• Pain Scale (Numerical pain scale)

  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.

  The first 24 hours: NPS 1, 2, 3, 4, 5, 6, 7, 8, 9

Secondary Outcomes (1)

• Complication (TRUSG-PBx Complication Monitoring Form)

  Hematuria, hematospermia, rectal bleeding, urinary retention, dysuria, anal pain seen in the first 24 hours and 1 week

Other Outcomes (1)

• Comfort (Perianesthesia Comfort Scale (PCS)

  Comparison of patients' Perianesthesia Comfort Scale (PCS) scores in the first 24 hours

Study Arms (2)

TENS

EXPERIMENTAL

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.

Other: Transcuten Electriacal Nerve Stimulation

CONTROL

NO INTERVENTION

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.

Interventions

Transcuten Electriacal Nerve Stimulation OTHER

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.

TENS

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: prostate
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to communicate,
• Those who are over 40 years old,
• Being literate,
• No previous history of chronic pain,
• Not addicted to alcohol or drugs,
• Without bleeding diathesis and active urinary tract infection,
• Having no cognitive impairment, neurological or psychiatric disease,
• Do not have any inflammatory rheumatological, neurological or cognitive disease,
• No contraindications for electrotherapy (pacemaker, arrhythmia, epilepsy, dermatological diseases),
• Not using chronic opioids, antidepressants or psychoactive drugs,
• Those who have not had TENS application before,
• No skin lesions in the electrode connection areas,
• No significant anorectal disease (wound, fistula, fissure, hemorrhoids, etc.),
• As a result of the evaluation by the physician, there is no harm in applying TENS,
• Patients who voluntarily agreed to participate in the research were included.

You may not qualify if:

• Lidocaine gel was applied to the anal area and rectum before the biopsy, or a different anesthetic method was used (IV, IM, rectal anesthetic/analgesic drug application or general anesthesia, etc.),
• Coming for prostate biopsy followed by Foley catheter,
• Patients who did not agree to participate in the research were not included in the sample.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Sariçam, 01330, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: May 16, 2024
• Study Start: January 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: December 27, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

TU (1)