Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal

NCT05032469 | Completed

• 1 other identifier: 24074710-38
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Anxiety; Cardiac surgery; Chest tubes; Nursing; Pain; Reflexology

Outcome Measures

Primary Outcomes (2)

• Numeric Pain Rating Scale Change

  Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)

  1st postoperative day change from baseline pain score at after intervention, 2nd postoperative day change from baseline pain score at during, 15th min,1h after chest tube removal

• Profile of Mood States Scale Tension-Anxiety Subscale Change

  Profile of Mood States Scale Tension-Anxiety Subscale includes the following nine items: tense, shaky, on edge, panicky, uneasy, restless, nervous and anxious. Each item was graded as 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a bit) or 4 (extremely) and the sum of the items is the total scale, varying from 0 (no tension-anxiety) - 36 (most tension-anxiety).

  1st postoperative day change from baseline pain score at after intervention, 2nd postoperative day change from baseline pain score at during, 15th min after chest tube removal

Secondary Outcomes (2)

• Numerical Satisfaction Evaluation Form

  Second postoperative day

• Form to determine the feelings and thoughts of the patients about reflexology application and chest tube removal

  Second postoperative day

Study Arms (2)

Refloxology Intervention

EXPERIMENTAL

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.

Other: Reflexology

Standart Care

NO INTERVENTION

Participants in the control group will receive standart postoperative care.

Interventions

Reflexology 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

Refloxology Intervention

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead
• Gazi University: collaborator

Study Sites (1)

Baskent University Ankara Hospital

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Elif BUDAK ERTÜRK, MsN,RN, PhD

  Başkent University, Faculty of Health Science, Department of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Single (Investigator)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 2, 2021
• Study Start: November 30, 2018
• Primary Completion: July 30, 2020
• Study Completion: November 25, 2020
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)