The Effect of Acupressure on Procedural Pain, Anxiety and Hemodynamic Variables During Chest Tube Removal

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875337
• Other study ID #: MersinU.
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: December 25, 2024

Study information

• Verified date: August 2023
• Source: Mersin University
• Contact: Tugba ÇAM YANIK, PhD
• Phone: 05067703216
• Email: tugbacam[@]mersin.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 25, 2024
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Hemodynamic Instability
• Pain, Postoperative
• Pain, Procedural

Intervention

Other:
• Acupressure
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.
• Placebo acupressure
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.

Locations

Country	Name	City	State
Turkey	Mersin University Hospital	Mersin	Yenisehir

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 15 minutes
Secondary	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.	Baseline and 15 minutes
Secondary	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.	Baseline and 15 minutes.
Secondary	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.	Baseline and 15 minutes
Secondary	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.	Baseline and 15 minutes
Secondary	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.	Baseline and 15 minutes
Secondary	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.	Baseline and 15 minutes