Clinical trial NCT05875337: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Anxiety
Hemodynamic Instability
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind randomized controlled experimental trial
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Change from baseline in Pain on the Visual Analog Scale at 15 minutes
timeFrame: Baseline and 15 minutes
Secondary outcomes:
measure: Change from baseline in Anxiety on the State Anxiety Inventory at 15 minutes
timeFrame: Baseline and 15 minutes
measure: Change from baseline in SpO2 at 15 minutes.
timeFrame: Baseline and 15 minutes.
measure: Change from in respiration rate at 15 minutes.
timeFrame: Baseline and 15 minutes
measure: Change from in systolic blood pressure at 15 minutes
timeFrame: Baseline and 15 minutes
measure: Change from in diastolic blood pressure at 15 minutes.
timeFrame: Baseline and 15 minutes
measure: Change from in heart rate at 15 minutes.
timeFrame: Baseline and 15 minutes
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University Hospital
state: Yenişehir
Study officials:
affiliation: Mersin University
name: Gülay ALTUN UĞRAŞ, PhD
role: STUDY_DIRECTOR
affiliation: Necmettin Erbakan University
name: Serpil YÜKSEL, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: England
name: Didem KANDEMİR, PhD
role: PRINCIPAL_INVESTIGATOR
References: