Colorectal SurgeryNCT06480318
Effect of TENS of Intestınal Functıons, Pain and Analgesis Consumptıon Amount
A study testing TENS in people with Colorectal Surgery and Pain, Postoperative, run by İlknur tura.
Trial summary
In this study, the effect of TENS applied to patients undergoing open colorectal surgery on bowel functions, pain and analgesia consumption amount will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery, Pain, Postoperative
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 5 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those over 18 years of age,
- Able to communicate verbally,
- Those who have undergone colorectal open surgery,
- American Society of Anesthesiology (ASA) evaluation I, II, III,
- As a result of evaluation by the physician, there is no harm in applying TENS,
- Patients who agreed to participate in the study voluntarily were included in the sample group.
Who cannot join
- In need of mechanical ventilation,
- Having an infected wound in the surgery area,
- Having undergone rectal surgery,
- Using opioids before surgery,
- Previous history of chronic pain, alcohol or drug addiction,
- Those with cognitive and mental disabilities,
- Those with a pacemaker and arrhythmia,
- Epidural analgesia/patient-controlled analgesia was applied in the postoperative period,
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Tens Applied In Colorectal Surgery on Intestınal Functıons, Pain and Analgesis Consumptıon Amount
In this study, the effect of TENS applied to patients undergoing open colorectal surgery on bowel functions, pain and analgesia consumption amount will be evaluated.
Read the detailed description
Colorectal cancers, inflammatory colon diseases, colorectal diseases for which medical treatment cannot be successful, diverticula, perforation, obstruction, etc. These conditions are among the conditions requiring colorectal surgical treatment. Colorectal cancer is the most common reason for colorectal surgery and causes illness and death all over the world. Conditions that cause pain in colorectal surgery: Painful drainage in perianal fistulas, hemorrhoidal diseases, perianal hernia, ulcerative colitis, surgical interventions, stoma and peristomal skin complications. In addition, patients experience serious pain when there is more than one source of pain due to the size of the incision area, cutting of skin and muscles, nerve damage, etc. When evaluated numerically, the pain experienced after surgery increases up to 8 out of 10, especially in the first 24 hours, and decreases below 4 after the 72nd hour. In cases where severe pain is not adequately controlled, patients do not want to move and the digestive system causes a decline in intestinal functions due to decreased blood flow. For effective pain management, pain should be questioned constantly, its location and spread, character (noiceptive, neuropathic, visceral), severity, duration (continuous, intermittent, paroxysmal), factors that increase or decrease, symptoms accompanying the pain, symptoms caused by the pain, previous treatments. The reasons that prevent the evaluation of the response and pain should be determined and patient-specific pain management should be planned.
In addition, strong opioids such as morphine and talinate, which are administered in high doses for pain treatment, cause the bowel functions to slow down and increase the rates of paralytic ileus, constipation and distension. In this context, the multimodal analgesia approach, in which more than one method is used, provides more effective pain control than a single analgesia approach and also reduces the complication rates in bowel functions.
It is a non-invasive and safe analgesic method in gastrointestinal surgery that acts through multiple mechanisms. In the nursing regulation published in 2011, independent, semi-dependent and dependent roles of nurses were defined. TENS should be applied in the postoperative period to provide effective analgesia, reduce the use of pharmacological analgesics, and improve the patients bowel functions in the early period. The mechanism of action of TENS on the body is explained by two types of mechanisms. Since nurses, who have a key role in pain management, do not have the authority to decide on the type and dose of analgesic medication to be administered, their role in pain management is limited, but nurses. If there is more than one source of pain due to the size of the incision area, cutting of skin and muscles, nerve damage, etc., patients experience serious pain and regression in bowel functions due to pain.
- Conditions
- Colorectal Surgery, Pain, Postoperative
- Being tested
- TENS
- Keywords
- Colorectal Surgery, Pain assessment, TENS, Nurse
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
The device is portable and battery-powered to preserve the patient functional activity. The device has two channels and the parameters of each channel can be adjusted independently of the other. The device contains a power supply, amplifier and electrodes to give a warning. The power supply and amplifier are located within the TENS device. Electrodes are connected to the device via cables. The current produced in the power supply is increased in the amplifier and reaches the electrodes. The device is self-gel to facilitate the transmission of current between the electrodes made of carbon silicon alloy and the skin surface. In the research, a dual-channel, four-electrode (5 cm x 5cm) TENS device will be used. TENS application will be applied every 12 hours, twice and for 20 minutes, 24 hours after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Standart Care | No intervention | Application in the Preoperative Period: Before the surgery, HTBF and SAS will be applied to both groups and pain assessment will be made once. In addition, the intestinal functions of both groups will be questioned and recorded during each procedure. TENS will not be applied to the control group, and to the TENS group, 11.,-23.,-35.,-47. TENS will be applied a total of 4 times for 20 minutes between hours. There will be no intervention in the routine analgesic application of the clinic for both groups. |
| TENS (Transcutaneous electrical nerve stimulation) | Experimental | In the postoperative period, an information form regarding the surgery will be filled out in both groups. In addition, 11th and 12th in the control and TENS groups; 23rd and 24th; Pain assessment will be made with PSA a total of 8 times at the 35th and 36th hours, and at the 47th and 48th hours. In the TENS group, at the 11th hour (just before TENS), at the 12th hour (1 hour after TENS), at the 23rd hour (just before TENS), at the 24th hour (1 hour after TENS), at the 35th hour. Pain will be re-evaluated at 30 hours (just before TENS), 36 hours (1 hour after TENS), 47 hours (just before TENS), 48 hours (1 hour after TENS). Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
The patient will be monitored until the 48th hour after surgery. 11th and 12th in the standard care and TENS group; 23rd and 24th; Pain assessment will be made with a numerical pain scale a total of 8 times at the 35th and 36th hours, and at the 47th and 48th hours.
In the TENS group, at the 11th hour (just before TENS), at the 12th hour (1 hour after TENS), At the 23rd hour (just before TENS), at the 24th hour (1 hour after TENS), At 35th hour (just before TENS), at 36th hour (1 hour after TENS), Pain will be re-evaluated at the 47th hour (just before TENS) and at the 48th hour (1 hour after TENS).
Intestinal functions of both groups will be questioned and recorded during each procedure.
TENS will not be applied to the standard care group. In the TENS group, 11.,-23.,-35.,-47. TENS will be applied a total of 4 times for 20 minutes between hours.
Patients' pain is expected to score at most 2-3 on a scale of 0-10.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion5 Sep 2024 (estimated)
- Study completion5 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- İlknur tura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, İlknur tura, Cukurova University
- Investigators
- sevilay erden, Phd, Study director, Cukurova Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480318
- Sponsor's protocol ID
- 13.10.2023/137
- Status last verified
- Jul 2024
- First submitted
- 13 Jun 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital approval is awaited for the study, and after approval, the data collection phase will begin.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tens Applied In Colorectal Surgery on Intestınal Functıons, Pain and Analgesis Consumptıon Amount
- ClinicalTrials.gov ID
- NCT06480318
- Acronym / sponsor ID
- 13.10.2023/137
- Conditions
- Colorectal Surgery, Pain, Postoperative
- Keywords
- Colorectal Surgery, Pain assessment, TENS, Nurse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- İlknur turaUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 5 Sep 2024 (estimated)
- Study completion
- 5 Jul 2025 (estimated)
- First posted
- 28 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.
In this study, the effect of TENS applied to patients undergoing open colorectal surgery on bowel functions, pain and analgesia consumption amount will be evaluated.
Detailed description
Colorectal cancers, inflammatory colon diseases, colorectal diseases for which medical treatment cannot be successful, diverticula, perforation, obstruction, etc. These conditions are among the conditions requiring colorectal surgical treatment. Colorectal cancer is the most common reason for colorectal surgery and causes illness and death all over the world. Conditions that cause pain in colorectal surgery: Painful drainage in perianal fistulas, hemorrhoidal diseases, perianal hernia, ulcerative colitis, surgical interventions, stoma and peristomal skin complications. In addition, patients experience serious pain when there is more than one source of pain due to the size of the incision area, cutting of skin and muscles, nerve damage, etc. When evaluated numerically, the pain experienced after surgery increases up to 8 out of 10, especially in the first 24 hours, and decreases below 4 after the 72nd hour. In cases where severe pain is not adequately controlled, patients do not want to move and the digestive system causes a decline in intestinal functions due to decreased blood flow. For effective pain management, pain should be questioned constantly, its location and spread, character (noiceptive, neuropathic, visceral), severity, duration (continuous, intermittent, paroxysmal), factors that increase or decrease, symptoms accompanying the pain, symptoms caused by the pain, previous treatments. The reasons that prevent the evaluation of the response and pain should be determined and patient-specific pain management should be planned.
In addition, strong opioids such as morphine and talinate, which are administered in high doses for pain treatment, cause the bowel functions to slow down and increase the rates of paralytic ileus, constipation and distension. In this context, the multimodal analgesia approach, in which more than one method is used, provides more effective pain control than a single analgesia approach and also reduces the complication rates in bowel functions.
It is a non-invasive and safe analgesic method in gastrointestinal surgery that acts through multiple mechanisms. In the nursing regulation published in 2011, independent, semi-dependent and dependent roles of nurses were defined. TENS should be applied in the postoperative period to provide effective analgesia, reduce the use of pharmacological analgesics, and improve the patients bowel functions in the early period. The mechanism of action of TENS on the body is explained by two types of mechanisms. Since nurses, who have a key role in pain management, do not have the authority to decide on the type and dose of analgesic medication to be administered, their role in pain management is limited, but nurses. If there is more than one source of pain due to the size of the incision area, cutting of skin and muscles, nerve damage, etc., patients experience serious pain and regression in bowel functions due to pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standart Care | No intervention | –Application in the Preoperative Period: Before the surgery, HTBF and SAS will be applied to both groups and pain assessment will be made once. In addition, the intestinal functions of both groups will be questioned and recorded during each procedure. TENS will not be applied to the control group, and to the TENS group, 11.,-23.,-35.,-47. TENS will be applied a total of 4 times for 20 minutes between hours. There will be no intervention in the routine analgesic application of the clinic for both groups. |
| TENS (Transcutaneous electrical nerve stimulation) | Experimental | Device: TENSIn the postoperative period, an information form regarding the surgery will be filled out in both groups. In addition, 11th and 12th in the control and TENS groups; 23rd and 24th; Pain assessment will be made with PSA a total of 8 times at the 35th and 36th hours, and at the 47th and 48th hours. In the TENS group, at the 11th hour (just before TENS), at the 12th hour (1 hour after TENS), at the 23rd hour (just before TENS), at the 24th hour (1 hour after TENS), at the 35th hour. Pain will be re-evaluated at 30 hours (just before TENS), 36 hours (1 hour after TENS), 47 hours (just before TENS), 48 hours (1 hour after TENS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Those over 18 years of age,
- Able to communicate verbally,
- Those who have undergone colorectal open surgery,
- American Society of Anesthesiology (ASA) evaluation I, II, III,
- As a result of evaluation by the physician, there is no harm in applying TENS,
Key exclusion criteria (8 listed)
- In need of mechanical ventilation,
- Having an infected wound in the surgery area,
- Having undergone rectal surgery,
- Using opioids before surgery,
- Previous history of chronic pain, alcohol or drug addiction,
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 |
|---|---|---|
| TENSThe device is portable and battery-powered to preserve the patient functional activity. The device has two channels and the parameters of each channel can be adjusted independently of the other. The device contains a power supply, amplifier and electrodes to give a warning. The power supply and amplifier are located within the TENS device. Electrodes are connected to the device via cables. The current produced in the power supply is increased in the amplifier and reaches the electrodes. The device is self-gel to facilitate the transmission of current between the electrodes made of carbon silicon alloy and the skin surface. In the research, a dual-channel, four-electrode (5 cm x 5cm) TENS device will be used. TENS application will be applied every 12 hours, twice and for 20 minutes, 24 hours after the surgery. | Device | TENS (Transcutaneous electrical nerve stimulation) |
Primary outcome
Primary Outcome Measure
Time frame: 48 hours
The patient will be monitored until the 48th hour after surgery. 11th and 12th in the standard care and TENS group; 23rd and 24th; Pain assessment will be made with a numerical pain scale a total of 8 times at the 35th and 36th hours, and at the 47th and 48th hours. In the TENS group, at the 11th hour (just before TENS), at the 12th hour (1 hour after TENS), At the 23rd hour (just before TENS), at the 24th hour (1 hour after TENS), At 35th hour (just before TENS), at 36th hour (1 hour after TENS), Pain will be re-evaluated at the 47th hour (just before TENS) and at the 48th hour (1 hour after TENS). Intestinal functions of both groups will be questioned and recorded during each procedure. TENS will not be applied to the standard care group. In the TENS group, 11.,-23.,-35.,-47. TENS will be applied a total of 4 times for 20 minutes between hours. Patients' pain is expected to score at most 2-3 on a scale of 0-10.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No. Hospital approval is awaited for the study, and after approval, the data collection phase will begin.
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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.
sevilay erden, Phd study director
Cukurova Universty
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Colorectal Surgery and Pain, Postoperative, run by İlknur tura.
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 6 inclusion and 8 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 23 Jul 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?
Contact ilknur tura, MsC (+903223386084, itura@cu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 48 hours). 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 23 Jul 2024.