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

NCT05875337 | Completed

• 1 other identifier: MersinU.
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Anxiety; Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from baseline in Anxiety on the State Anxiety Inventory at 15 minutes

  Baseline and 15 minutes

• Change from baseline in SpO2 at 15 minutes.

  Baseline and 15 minutes.

• Change from in respiration rate at 15 minutes.

  Baseline and 15 minutes

• Change from in systolic blood pressure at 15 minutes

  Baseline and 15 minutes

• Change from in diastolic blood pressure at 15 minutes.

  Baseline and 15 minutes

Study Arms (2)

Acupressure Group (experimental)

EXPERIMENTAL

In the acupressure groups the points are LI4, LI11 and HT7.

Other: Acupressure

Placebo Acupressure Group (control)

PLACEBO COMPARATOR

In the placebo acupressure group the points are 1.5 cm away from LI4, LI11 and HT7 points.

Other: Placebo acupressure

Interventions

Acupressure OTHER

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.

Acupressure Group (experimental)

Placebo acupressure OTHER

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.

Placebo Acupressure Group (control)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With only one chest tube after open heart surgery,
• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University Hospital

Mersin, Yenişehir, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders

Interventions

Acupressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gülay ALTUN UĞRAŞ, PhD

  Mersin University

  STUDY DIRECTOR

• Serpil YÜKSEL, PhD

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

• Didem KANDEMİR, PhD

  England

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Double-blind randomized controlled experimental trial

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 25, 2023
• Study Start: May 25, 2023
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

TU (1)