An interventional study of TENS and TAES in Transcutaneous Electric Nerve Stimulation, sponsored by Yuksek Ihtisas University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-03.
Sponsored by Yuksek Ihtisas University · Not applicable, Interventional, and Supportive care
The purpose of this study is to determine the effects of transcutaneous electrical nerve stimulation (TENS) and transcutaneous acupoint electrical stimulation (TAES) on pain and analgesic drug consumption in patients who had undergone abdominal surgery with a midline incision. Evidence for the effects of and transcutaneous electrical stimulation on pain and analgesic consumption on patients undergoing abdominal surgery with severe pain experience and high levels of neuroendocrine stress response is uncertain.
This research was conducted as a randomized controlled trial. 158 patients who had undergone abdominal surgery with diagnosis of gastric and colorectal cancer were assessed for eligibility. This research sample consisted of 48 patients who underwent abdominal surgery with a midline incision. The patients were randomized into three groups, the first intervention group, which used TENS (around the incision), the second intervention group, which used TAES (ST25, P6, ST36, Lİ4 acupuncture points) and the control group, which did not. Electric stimulation was performed at the 30th minute, second, 18th, 21st, 40th, and 45th hours after the operation. Pain scores and analgesic consumption were assessed in the first 48 hours after surgical intervention.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's enrollment of 48 is below the median of 70 across 1,904 interventional studies indexed under Pain.
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Exclusion Criteria:
The Patient Controlled Analgesia infusion was started right after the surgery. TENS was applied to around the incision.
Other: TENS
The Patient Controlled Analgesia infusion was started right after the surgery. TAES was applied to acupuncture points.
Other: TAES
No stimulation was performed to the patients in the control group.
4 electrodes were placed 2-3 cm lateral to the incision of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min
Also known as: First Intervention Group
4 electrodes were placed at the ST25, P6, ST36, and LI4 acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min
Also known as: Second Intervention Group
Postoperative pain intensity
First Intervention Group: Electrical stimulation was implemented at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery. Second Intervention Group: Electrical stimulation was implemented at acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery. Control Group: No intervention was performed to the patients in the control group. The pain intensity of each groups' patients were recorded and compred at the post-operative 2, 18, 22, 42, and 46th hours. Pain intensity was evaluated with VAS. VAS with a range of 1-10 points was used while evaluating the pain intensity of all patients .The increase of the scale score shows that the pain intensity increases.
Time frame: The pain levels were evaluated and compared within postoperative first 48 hours.
Nausea severity
VAS with a range of 1-10 points was used while evaluating the nausea severity of all patients .The increase of the scale score shows that the nausea severity increases.
Time frame: The nausea severity of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.
Antiemetic drug consumption
The antiemetic drug amount administered to the patients was recorded in mg.
Time frame: Antiemetic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.
Pulmonary function tests
The pulmonary functions of the patients were evaluated with a portable spirometer. Peak expiratory flow (PEF) and forced vital capacity (FVC) values were recorded. The measurement of respiratory functions was performed with the patient wrapping the disposable mouthpiece well with the lips during the measurement. The patient was asked to breathe deeply and exhale suddenly and quickly. This process was repeated three times and the best performance was taken as the base value.
Time frame: Pulmonary function evaluations of the patients were performed at the 24th and 48th hours. Patients were assessed in postoperative first 48 hours.
Vomiting
Vomiting: The number of times the patients vomited was recorded
Time frame: Vomiting status of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.
Analgesic drug consumption
All patients were administered intravenous tramadol hydrochloride infusion with the Patient Controlled Analgesia for the first 48 hours. Dexketoprofen trometamol vial intravenous and/or 50 mg. Pethidine hydrochloride intramuscular was used as the rescue analgesic.
Time frame: Analgesic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Yuksek Ihtisas University