Effect of TENS of Intestınal Functıons, Pain and Analgesis Consumptıon Amount

NCT06480318 | Not Yet Recruiting

• 1 other identifier: 13.10.2023/137
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Surgery; Pain, Postoperative

Keywords

Colorectal Surgery; Pain assessment; TENS; Nurse

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours

Study Arms (2)

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).

Device: TENS

Interventions

TENS DEVICE

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.

TENS (Transcutaneous electrical nerve stimulation)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 18 years and over
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• İlknur tura: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• sevilay erden, Phd

  Cukurova Universty

  STUDY DIRECTOR

Central Study Contacts

ilknur tura, MsC

CONTACT

+903223386084; itura@cu.edu.tr

sevilay erden, Phd

CONTACT

+903223386084; serden@cu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 28, 2024
• Study Start: September 1, 2024
• Primary Completion: September 5, 2024
• Study Completion: July 5, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share