Back to resultsThe Effect of Acupressure on Procedural Pain, Anxiety and Hemodynamic Variables During Chest Tube Removal
Primary Purpose
Pain, Postoperative, Anxiety, Hemodynamic Instability
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupressure
Placebo acupressure
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria: With only one chest tube after open heart surgery, 18 years of age or older, Conscious and cooperative, Speaks and understands Turkish, General condition and hemodynamic variables are stable, Planned surgical intervention, No previous chest tube experience, Acupressure/placebo acupressure without scars, scars, tenderness in the area to be acupressure, No active COVID-19 infection, Does not have any psychiatric diagnosis, Not using psychiatric and/or local neuromuscular blocking drugs, Patients who agreed to participate in the study (signed the Informed Consent Form) Exclusion Criteria: No chest tube or multiple chest tubes after open heart surgery, Under 18 years of age, Conscious and uncooperative, Speaking Turkish but not understanding it, Unstable general condition and hemodynamic variables, Underwent emergency surgical intervention, Anyone with previous chest tube experience, Wounds, scars, tenderness in the area where acupressure/placebo acupressure will be applied, With active COVID-19 infection, Has an existing psychiatric diagnosis, Psychiatric and/or local neuromuscular blocking drugs, Patients who did not agree to participate in the study (did not sign the Informed Consent Form).
Sites / Locations
- Mersin University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Acupressure Group (experimental)
Placebo Acupressure Group (control)
Arm Description
In the acupressure groups the points are LI4, LI11 and HT7.
In the placebo acupressure group the points are 1.5 cm away from LI4, LI11 and HT7 points.
Outcomes
Primary Outcome Measures
Change from baseline in Pain on the Visual Analog Scale at 15 minutes
The VAS, which is a safe, easily applicable scale tool generally accepted in the literature, consists of a 10 cm long line and subjective descriptive statements at both ends of the scale (0 cm=none and 10 cm=highest degree of presence). The individual marks the appropriate place on the scale on this 10 cm line. The distance from the beginning of the scale to the mark is measured with a ruler and the pain level of the individual is determined numerically in cm.
Secondary Outcome Measures
Change from baseline in Anxiety on the State Anxiety Inventory at 15 minutes
The total score of the scale is calculated by subtracting the total weighted score of the inverted statements from the total weighted score of the direct statements and adding the number 50, which is the predetermined and unchanging value of the State Anxiety Inventory. A score of 30 and above on this scale indicates moderate anxiety and a score of 45 and above indicates severe anxiety.
Change from baseline in SpO2 at 15 minutes.
Oxygen saturation measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Change from in respiration rate at 15 minutes.
Respiration rate measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Change from in systolic blood pressure at 15 minutes
Systolic blood pressure measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Change from in diastolic blood pressure at 15 minutes.
Diastolic blood pressure measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Change from in heart rate at 15 minutes.
Heart rate measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05875337
Brief Title
The Effect of Acupressure on Procedural Pain, Anxiety and Hemodynamic Variables During Chest Tube Removal
Official Title
The Effect of Acupressure on Procedural Pain, Anxiety and Hemodynamic Variables During Chest Tube Removal in Patients With Open Heart Surgery: A Double-Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
December 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
When the literature was reviewed, many studies were found in which various non-pharmacologic interventions such as reflexology, music therapy, slow and deep breathing exercises, relaxation exercises and cold application were examined in the control of pain associated with chest tube removal. However, a limited number of studies have examined the effect of acupressure on the control of pain caused by chest tube removal; there are no studies in which LI4, LI11 and HT7 acupressure points were used and anxiety level and hemodynamic variables were examined along with procedural pain. Thus, the aim of this study was to investigate the effect of acupressure on procedural pain, anxiety and hemodynamic variables after chest tube removal after open heart surgery.
Detailed Description
Before starting the acupressure/placebo acupressure point application, the area around the area where pressure will be applied for 20-30 seconds will be gently rubbed with the palm of the hand. By gently rubbing the surrounding tissue, tension and tissue sensitivity will be reduced and the tissue will be relaxed by heating, relaxing and preparing the point area. Pressure will be applied to the determined points (LI4, LI11 and HT7 or points 1.5 cm away) with the thumb, index or middle finger manually for 5 seconds to create a depth of 1-1.5 cm, and rest for 2 seconds. Each point will be applied for 2 minutes and the application will last 12 minutes.
When acupressure/plesebo acupressure application is completed, the chest tube will be removed by the physician. Procedural pain level, anxiety level and hemodynamic variables of all patients in the acupressure and placebo acupressure groups will be re-evaluated immediately and 15 minutes after removal of the chest tube.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anxiety, Hemodynamic Instability
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind randomized controlled experimental trial
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
In the study, a researcher (F.E.Ö.) will determine the acupressure and placebo points to be applied to the patients. However, the certified researcher (T.Ç.Y.) who will perform the acupressure and placebo application will perform the application without knowing whether these points are acupressure or placebo points and will be blinded. The participants will not know whether they are in the acupressure or placebo acupressure group. Thus, the research will be carried out as a double-blind randomized controlled trial. When the research is completed, the data of the acupressure and placebo acupressure groups (coded as A or B) will be transferred to the computer environment by a researcher independent of the research, and the data will be analyzed and reported by a statistician using blinded technique.
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupressure Group (experimental)
Arm Type
Experimental
Arm Description
In the acupressure groups the points are LI4, LI11 and HT7.
Arm Title
Placebo Acupressure Group (control)
Arm Type
Placebo Comparator
Arm Description
In the placebo acupressure group the points are 1.5 cm away from LI4, LI11 and HT7 points.
Intervention Type
Other
Intervention Name(s)
Acupressure
Intervention Description
Before starting the acupressure point application, the area around the area where the pressure will be applied for 20-30 seconds will be gently rubbed with the palm of the hand. By gently rubbing the surrounding tissue, tension and tissue sensitivity will be reduced and the tissue will be relaxed by heating, relaxing and preparing the point area. Pressure will be applied to the determined points (LI4, LI11 and HT7) with the thumb, index or middle finger manually for 5 seconds to create a depth of 1-1.5 cm and rest for 2 seconds. Each point will be applied for 2 minutes and the application will last 12 minutes.
Intervention Type
Other
Intervention Name(s)
Placebo acupressure
Intervention Description
Before starting the application to the placebo acupressure point, the area around the area where pressure will be applied for 20-30 seconds will be gently rubbed with the palm of the hand. By gently rubbing the surrounding tissue, tension and tissue sensitivity will be reduced and the tissue will be relaxed by heating, relaxing and preparing the point area. Light pressure will be applied to the determined points (1.5 cm away from LI4, LI11 and HT7 points) with the thumb, index or middle finger. Each point will be applied for 2 minutes and the application will last 12 minutes.
Primary Outcome Measure Information:
Title
Change from baseline in Pain on the Visual Analog Scale at 15 minutes
Description
The VAS, which is a safe, easily applicable scale tool generally accepted in the literature, consists of a 10 cm long line and subjective descriptive statements at both ends of the scale (0 cm=none and 10 cm=highest degree of presence). The individual marks the appropriate place on the scale on this 10 cm line. The distance from the beginning of the scale to the mark is measured with a ruler and the pain level of the individual is determined numerically in cm.
Time Frame
Baseline and 15 minutes
Secondary Outcome Measure Information:
Title
Change from baseline in Anxiety on the State Anxiety Inventory at 15 minutes
Description
The total score of the scale is calculated by subtracting the total weighted score of the inverted statements from the total weighted score of the direct statements and adding the number 50, which is the predetermined and unchanging value of the State Anxiety Inventory. A score of 30 and above on this scale indicates moderate anxiety and a score of 45 and above indicates severe anxiety.
Time Frame
Baseline and 15 minutes
Title
Change from baseline in SpO2 at 15 minutes.
Description
Oxygen saturation measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Time Frame
Baseline and 15 minutes.
Title
Change from in respiration rate at 15 minutes.
Description
Respiration rate measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Time Frame
Baseline and 15 minutes
Title
Change from in systolic blood pressure at 15 minutes
Description
Systolic blood pressure measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Time Frame
Baseline and 15 minutes
Title
Change from in diastolic blood pressure at 15 minutes.
Description
Diastolic blood pressure measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Time Frame
Baseline and 15 minutes
Title
Change from in heart rate at 15 minutes.
Description
Heart rate measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Time Frame
Baseline and 15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
With only one chest tube after open heart surgery,
18 years of age or older,
Conscious and cooperative,
Speaks and understands Turkish,
General condition and hemodynamic variables are stable,
Planned surgical intervention,
No previous chest tube experience,
Acupressure/placebo acupressure without scars, scars, tenderness in the area to be acupressure,
No active COVID-19 infection,
Does not have any psychiatric diagnosis,
Not using psychiatric and/or local neuromuscular blocking drugs,
Patients who agreed to participate in the study (signed the Informed Consent Form)
Exclusion Criteria:
No chest tube or multiple chest tubes after open heart surgery,
Under 18 years of age,
Conscious and uncooperative,
Speaking Turkish but not understanding it,
Unstable general condition and hemodynamic variables,
Underwent emergency surgical intervention,
Anyone with previous chest tube experience,
Wounds, scars, tenderness in the area where acupressure/placebo acupressure will be applied,
With active COVID-19 infection,
Has an existing psychiatric diagnosis,
Psychiatric and/or local neuromuscular blocking drugs,
Patients who did not agree to participate in the study (did not sign the Informed Consent Form).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuğba ÇAM YANIK, PhD
Phone
05067703216
Email
tugbacam@mersin.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülay ALTUN UĞRAŞ, PhD
Organizational Affiliation
Mersin University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Serpil YÜKSEL, PhD
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Didem KANDEMİR, PhD
Organizational Affiliation
England
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mersin University Hospital
City
Mersin
State/Province
Yenişehir
ZIP/Postal Code
33343
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
Email
tugbacam@mersin.edu.tr
12. IPD Sharing Statement
Learn more about this trial
The Effect of Acupressure on Procedural Pain, Anxiety and Hemodynamic Variables During Chest Tube Removal
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