Clinical trial NCT06357429: Evaluation of the Effect of the LI4 Cold Application
Official title: Evaluation of the Effect of Cold Application on the LI4 Point After Surgery on Acute Pain, Nausea and Anxiety Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Nausea
Anxiety
Keywords: postoperative pain
cold application
LI4
anxiety
nausea
after surgical
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is an experimental study conducted to evaluate the effectiveness of cold application to the LI4 point of the hand to reduce/eliminate pain, nausea and anxiety in postoperative patients. The population of the study consisted of 116 individuals who underwent abdominal surgery with the open surgery method in a state hospital between February 2022 and November 2022 and were followed up in the inpatient ward. The study was completed with 80 individuals constituting the experimental group (n=40) and the control group (n=40). Patient information form, Mcgill Melzack short pain form, Visual Analog Scale, STAI - TX and Cold Application Evaluation Form were used to collect data. Patients in the experimental group underwent cold application with ice cubes for a total of 20 minutes as 2 minutes of cold application and 15 seconds of waiting 4-6 hours after the patient was admitted to the clinic after surgical intervention. Follow-up was performed before cold application, immediately after cold application, 30 minutes after the end of cold application, 1 hour and 2 hours after the end of cold application.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Can speak and understand Turkish
* Does not have any cognitive, affective and verbal problems that prevent them from communicating,
* No postoperative complications (bleeding, infection, etc.),
* Underwent surgery with general anesthesia,
* Standardized analgesia protocol implemented,
* Women without a physical hand or arm disability will be included.

Exclusion Criteria:

* Those with chronic diseases such as diabetes, blood pressure, etc,
* Allergic to cold,
* Women with a certain period of intensive care (excluding postoperative care room) follow-up after surgery will not be included in the study

Primary outcomes:
measure: Pain Level
timeFrame: 9 Months
measure: Nausea Level
timeFrame: 9 Months
measure: Anxiety Level
timeFrame: 9 Months
measure: Sensory characteristics, intensity and impact of pain
timeFrame: 9 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri University
state: Uskudar
Study officials:
affiliation: Sağlık Bilimleri University
name: Ayşegül ALİOĞULLARI, PhD Student
role: PRINCIPAL_INVESTIGATOR
References: