Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal

NCT ID: NCT05032469

Last Updated: 2023-07-18

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2020-11-25

Brief Summary

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In open heart surgeries, patients experience severe pain due to tissue trauma, damage to intercostal nerves, and muscle spasm due to pulling tubes from the mediastinal space and between the pleural leaves pull during chet tube removal (CTR). When acute pain is not relieved, the patient develops emotional, psychological (eg post-traumatic stress disorder) and physical problems (eg chronic pain) after surgery. Since this situation negatively affects the healing process, it increases the anxiety level of the patients and decreases the comfort level. Reflexology is one of the non-pharmacological methods used in the management of pain and anxiety after open heart surgery The aim of this randomized controlled study was to identify the effect of foot reflexology applied before chest tube removal process on pain and anxiety level. This study will be done a randomized-controlled trial to test the intervention.

Detailed Description

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Background: Patients undergoing cardiovascular surgery suffer from anxiety and pain due to the chest tube removal (CTR).

Objective/Hypothesis: The aim of this randomized controlled study was to identify the effect of foot reflexology applied before chest tube removal process on pain and anxiety level.The following hypotheses (H) were tested in this study:

H1a : There was a difference between the reflexology group and the control group in terms of pain level during CTR.

H1b : There was a difference between the reflexology group and the control group in terms of anxiety level during CTR.

H1c : There was a difference between the reflexology group and the control group in terms of the difference between the pain level before CTR and during CTR.

H1d : There was a difference between the reflexology group and the control group in terms of the difference between the anxiety level before CTR and during CTR.

Study design: A randomized controlled trial. Method: The study sample who has gone through coronary artery bypass graft surgery was randomly assigned to reflexology or the control group (twenty- eight each in). The primary outcomes were pain, evaluated using a numeric pain-rating scale, and anxiety evaluated by the profile of mood states scale tension-anxiety subscale, both measured first (before and after reflexology) and second postoperative days (before the reflexology and immediately after chest tube removal, 15th minutes and 1 h).

Conditions

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Chest Tube Removal Heart; Surgery, Heart, Functional Disturbance as Result Pain Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Single (Investigator)

Study Groups

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Refloxology Intervention

The first foot reflexology was applied to the intervention group for 30 min (20 min on the right foot, 10 min on the left foot) on the first postoperative day (24 h after the surgery). On the second postoperative day, 30 min of foot reflexology was applied to the patients who decided to chest tube removal (CTR). After the foot reflexology applied by the researcher, CTR was performed by the doctor within 10 min. Immediately after CTR, the patient's pain and anxiety level during CTR was measured. At the 15th minute after CTR, the pain and anxiety level of the patients was measured, their satisfaction with the reflexology application was measured. Then, the patients were asked to describe the pain and feelings and thoughts during CTR, 1 hr after CTR, pain level was measured, and they were asked to express their feelings and thoughts about the reflexology application.

Group Type EXPERIMENTAL

Reflexology

Intervention Type OTHER

Reflexology is a method that creates nervous, hormonal and energetic effects in the body using pressure, rubbing and stretching applied with special hand and finger techniques to reflex points corresponding to all parts, organs and systems of the body in the ears, hands and feet

Standart Care

Participants in the control group will receive standart postoperative care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Reflexology

Reflexology is a method that creates nervous, hormonal and energetic effects in the body using pressure, rubbing and stretching applied with special hand and finger techniques to reflex points corresponding to all parts, organs and systems of the body in the ears, hands and feet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients over 18 years who have CABG surgery
* Having at least two chest tube catheters
* Having chest tubes removed together
* Volunteering to participate in the research

Exclusion Criteria

* Patients with diagnosed with psychiatric illness
* Having orientation or confusion problems, complete vision or hearing loss, mental problems due to problems such as dementia, mental retardation, and language problems
* Having pacemaker, varicose veins in the ankles
* Having chronic pain
* Having femoral fracture and open wound on the sole of the foot
* Having acute infection and hyperthermia, thromboembolism, suspected deep vein thrombosis at the postoperatively
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role collaborator

Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Elif BUDAK ERTÜRK

Principal Investigator, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elif BUDAK ERTÜRK, MsN,RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Başkent University, Faculty of Health Science, Department of Nursing

Locations

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Baskent University Ankara Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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24074710-38

Identifier Type: -

Identifier Source: org_study_id

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