deltatrials
Completed NA INTERVENTIONAL 2-arm NCT06357429

Evaluation of the Effect of the LI4 Cold Application (LI4)

Evaluation of the Effect of Cold Application on the LI4 Point After Surgery on Acute Pain, Nausea and Anxiety Level

Sponsor: Saglik Bilimleri Universitesi

Interventions Cold Application
Updated 4 times since 2024 Last updated: Apr 4, 2024 Started: Feb 23, 2022 Primary completion: Nov 18, 2022 Completion: Nov 18, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Anxiety and Nausea and is currently completed. Saglik Bilimleri Universitesi leads this study, which shows 4 recorded versions since 2022 — indicating limited longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Study Description(click to expand)

It is a prospective study in which cold application is planned to reduce/eliminate the pain, nausea and anxiety experienced by patients after surgery. There are 2 different sample groups in the study. The first group consists of the experimental group in which cold application is planned to be applied to the hand LI4 point after surgical intervention and the control group in which routine interventions in the clinic are applied. Hypotheses H1 The pain levels of individuals who received cold application to the LI4 point after surgery are lower than those who received routine care. H2 Anxiety levels of individuals who underwent cold application to the LI4 point after surgery are lower than those who received routine care. H3 The nausea levels of individuals who underwent cold application to the LI4 point after surgery are lower than those who received routine care. Variables of the Study Independent Variables: Cold Application Dependent Variables: Socio-demographic characteristics, pain level, anxiety level, vital signs (body temperature, blood pressure, pulse, respiration), analgesic drug use, nausea level. The study was conducted in the inpatient wards of a state hospital. Research data were collected every weekday between February 28, 2022 and November 18, 2022 on Monday-Tuesday-Wednesday-Thursday-Thursday-Friday. The...

It is a prospective study in which cold application is planned to reduce/eliminate the pain, nausea and anxiety experienced by patients after surgery. There are 2 different sample groups in the study. The first group consists of the experimental group in which cold application is planned to be applied to the hand LI4 point after surgical intervention and the control group in which routine interventions in the clinic are applied.

Hypotheses H1 The pain levels of individuals who received cold application to the LI4 point after surgery are lower than those who received routine care.

H2 Anxiety levels of individuals who underwent cold application to the LI4 point after surgery are lower than those who received routine care.

H3 The nausea levels of individuals who underwent cold application to the LI4 point after surgery are lower than those who received routine care.

Variables of the Study Independent Variables: Cold Application Dependent Variables: Socio-demographic characteristics, pain level, anxiety level, vital signs (body temperature, blood pressure, pulse, respiration), analgesic drug use, nausea level. The study was conducted in the inpatient wards of a state hospital.

Research data were collected every weekday between February 28, 2022 and November 18, 2022 on Monday-Tuesday-Wednesday-Thursday-Thursday-Friday.

The study population consisted of 116 individuals who underwent abdominal surgery and were followed up in the inpatient ward. Inclusion Criteria

* Over 18 years of age * Can speak and understand Turkish * Does not have any cognitive, affective and verbal problems that prevent them from communicating, * No postoperative complications developed, * Underwent surgery with general anesthesia, * No cold allergies, * Standardized analgesia protocol implemented, * Intensive care follow-up continues as of the fourth hour of the postoperative period, * Women without a physical hand or arm disability will be included. Patient information form, Mcgill Melzack short pain form, Visual Analog Scale, STAI - TX and Cold Application Evaluation Form were used to collect data. In order to evaluate the comprehensibility of the forms created for data collection and the designed cold application process, a pre-application was performed with the participation of 10 patients who underwent open surgical intervention in the abdominal region in the inpatient ward of the hospital.

The data of the patients within the scope of the preliminary application were not included in the sample.

After the patient was taken to the individual room, his/her clinical status was evaluated. The purpose of the study, LI4 cold application method and its effect on pain were explained. Life findings were measured. Then, pain assessment was performed using the SCS and Mcgill Pain Scale Short Form. State Anxiety Scale and Trait Anxiety Scale were completed by the researcher using face-to-face interview method. After the end of the application, the patient's vital signs were evaluated. The efficacy of cold application was evaluated with SCS, Mcgill Pain Scale Short Form, State Anxiety Scale. At 30, 60 and 120 minutes after cold application, the same evaluations made after the application were repeated and recorded. After the 120th minute evaluation, the "Cold Application Evaluation Form" was completed.

Status Flow

~May 2024 – ~Jul 2024 · 2 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

4 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed NA

  2. Sep 2024 — Sep 2025 [monthly]

    Completed NA

  3. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  4. May 2024 — Jul 2024 [monthly]

    Completed NA

    First recorded

Feb 2022

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Saglik Bilimleri Universitesi
Data source: Saglik Bilimleri Universitesi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations