Evaluation of the Effect of the LI4 Cold Application

NCT06357429 | Completed DMC

• 1 other identifier: 171002100
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Nausea; Anxiety

Keywords

postoperative pain; cold application; LI4; anxiety; nausea; after surgical

Outcome Measures

Primary Outcomes (4)

• Pain Level

  Visual Analog Scale - There are numbers from 0 to 10 on the scale consisting of a 10 cm line used horizontally or vertically. The lowest number on the scale, 0, means "No Pain", 1-4 means "Mild Pain", 5-6 means "Moderate Pain" and 7-10 means "Intolerable Pain".

  9 Months

• Nausea Level

  Visual Analog Scale - There are numbers from 0 to 10 on the scale consisting of a 10 cm line used horizontally or vertically. The lowest number on the scale, 0, indicates "No Nausea", 1-4 indicates "Mild Nausea", 5-6 indicates "Moderate Nausea" and 7-10 indicates "Intolerable Nausea".

  9 Months

• Anxiety Level

  In the State Anxiety Scale, the answer options collected in four classes are (1) Never, (2) A little, (3) A lot and (4) Completely; the options in the Trait Anxiety Scale are (1) Almost never, (2) Sometimes, (3) Very often and (4) Almost always. There are two types of statements in the scales. These are (1) direct or straight statements and (2) reverse statements. Direct statements express negative emotions, while reversed statements express positive emotions. In direct statements, answers with a value of 4 indicate that anxiety is high. In reversed statements, answers with a value of 1 indicate high anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 on the state anxiety scale and items 21, 26, 27, 30, 33, 36 and 39 on the trait anxiety scale are inverted statements. The total score of both scales ranges between 20-80. An increase in the score indicates an increase in the level of anxiety.

  9 Months

• Sensory characteristics, intensity and impact of pain

  The McGill Pain Scale Short Form consists of three parts. Section One: This section includes 15 descriptive word groups. Of these, 11 assess the sensory and 4 assess the perceptual dimension of pain. These descriptive words are rated on an intensity scale from 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). In the first part of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score and total pain score. The sensory pain score was 0-33, the perceptual pain score was 0-12, and the total pain score was 0-45. An increase in the score indicates an increase in pain. Second Part: In the second part of the form, five word groups ranging from "mild pain" to "unbearable pain" were included to determine the severity of the patient's pain. Third Section: In the third part, the patient's current pain intensity was assessed using a visual comparison scale.

  9 Months

Study Arms (2)

cold application

EXPERIMENTAL

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

Other: Cold Application

Control

EXPERIMENTAL

The control group in which routine interventions in the clinic are applied.

Other: Cold Application

Interventions

Cold Application OTHER

Cold application was applied to the LI4 acupressure point on the patients' hands using an ice battery.

Control; cold application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglik Bilimleri University

Istanbul, Uskudar, 34674, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Nausea; Anxiety Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders; Postoperative Complications; Pathologic Processes

Study Officials

• Ayşegül ALİOĞULLARI, PhD Student

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD Student

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 10, 2024
• Study Start: February 23, 2022
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)