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

NCT ID: NCT05875337

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-25

Study Completion Date

2024-05-25

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative Anxiety Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind randomized controlled experimental trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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Acupressure Group (experimental)

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

Group Type EXPERIMENTAL

Acupressure

Intervention Type 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.

Placebo Acupressure Group (control)

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

Group Type PLACEBO_COMPARATOR

Placebo acupressure

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mersin University

OTHER

Sponsor Role lead

Responsible Party

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Tugba CAM YANIK

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülay ALTUN UĞRAŞ, PhD

Role: STUDY_DIRECTOR

Mersin University

Serpil YÜKSEL, PhD

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan University

Didem KANDEMİR, PhD

Role: PRINCIPAL_INVESTIGATOR

England

Locations

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Mersin University Hospital

Mersin, Yenişehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MersinU.

Identifier Type: -

Identifier Source: org_study_id

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