PainLI4NCT06357429
Evaluation of the Effect of the LI4 Cold Application
A study testing Cold Application in people with Pain and Nausea, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- What is being tested?
- Cold Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2022to 18 Nov 2022
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri University
Istanbul, Uskudar, 34674
About this study
Official title: Evaluation of the Effect of Cold Application on the LI4 Point After Surgery on Acute Pain, Nausea and Anxiety Level
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.
Read the 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.
- Being tested
- Cold Application
- Keywords
- postoperative pain, cold application, LI4, anxiety, nausea, after surgical
- Medical subject headings
- Pain, Nausea, Anxiety Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold ApplicationOther
Cold application was applied to the LI4 acupressure point on the patients' hands using an ice battery.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Cold Application |
| Control | Experimental | The control group in which routine interventions in the clinic are applied. Receives: Other: Cold Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start23 Feb 2022
- Primary completion18 Nov 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Alioğulları, Saglik Bilimleri Universitesi
- Investigators
- Ayşegül ALİOĞULLARI, PhD Student, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357429
- Sponsor's protocol ID
- 171002100
- Acronym
- LI4
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Cold Application on the LI4 Point After Surgery on Acute Pain, Nausea and Anxiety Level
- ClinicalTrials.gov ID
- NCT06357429
- Acronym / sponsor ID
- LI4 / 171002100
- Keywords
- postoperative pain, cold application, LI4, anxiety, nausea, after surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 10 Apr 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cold application | Experimental | Other: Cold ApplicationThe first group consists of the experimental group in which cold application is planned to be applied to the hand LI4 point after surgical intervention |
| Control | Experimental | Other: Cold ApplicationThe control group in which routine interventions in the clinic are applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Cold ApplicationCold application was applied to the LI4 acupressure point on the patients' hands using an ice battery. | Other | Control, cold application |
Primary outcome
Pain Level
Time frame: 9 Months
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".
Nausea Level
Time frame: 9 Months
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".
Anxiety Level
Time frame: 9 Months
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.
Sensory characteristics, intensity and impact of pain
Time frame: 9 Months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Ayşegül ALİOĞULLARI, PhD Student principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Application in people with Pain and Nausea, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: 9 Months). The study lists 4 primary outcomes in all. 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 10 Apr 2024.