search
Back to results

Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reflexology
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chest Tube Removal focused on measuring Anxiety, Cardiac surgery, Chest tubes, Nursing, Pain, Reflexology

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Baskent University Ankara Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Refloxology Intervention

Standart Care

Arm Description

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.

Participants in the control group will receive standart postoperative care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Numerical Satisfaction Evaluation Form
Numerical Satisfaction Evaluation Form includes values ranging from 0 (I am not satisfied), 10 (I am satisfied)
Form to determine the feelings and thoughts of the patients about reflexology application and chest tube removal
Six open ended questions about the feelings and thoughts of the patients about reflexology application and chest tube removal.

Full Information

First Posted
August 20, 2021
Last Updated
July 17, 2023
Sponsor
Baskent University
Collaborators
Gazi University
search

1. Study Identification

Unique Protocol Identification Number
NCT05032469
Brief Title
Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal
Official Title
Effect of The Foot Reflexology Applied Before Chest Tube Removal on the Pain And Anxiety Level: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
November 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
Collaborators
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Tube Removal, Heart; Surgery, Heart, Functional Disturbance as Result, Pain, Anxiety
Keywords
Anxiety, Cardiac surgery, Chest tubes, Nursing, Pain, Reflexology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Single (Investigator)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Refloxology Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standart Care
Arm Type
No Intervention
Arm Description
Participants in the control group will receive standart postoperative care.
Intervention Type
Other
Intervention Name(s)
Reflexology
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale Change
Description
Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)
Time Frame
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
Title
Profile of Mood States Scale Tension-Anxiety Subscale Change
Description
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).
Time Frame
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 Outcome Measure Information:
Title
Numerical Satisfaction Evaluation Form
Description
Numerical Satisfaction Evaluation Form includes values ranging from 0 (I am not satisfied), 10 (I am satisfied)
Time Frame
Second postoperative day
Title
Form to determine the feelings and thoughts of the patients about reflexology application and chest tube removal
Description
Six open ended questions about the feelings and thoughts of the patients about reflexology application and chest tube removal.
Time Frame
Second postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif BUDAK ERTÜRK, MsN,RN, PhD
Organizational Affiliation
Başkent University, Faculty of Health Science, Department of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baskent University Ankara Hospital
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06490
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal

We'll reach out to this number within 24 hrs