Chest Tube RemovalNCT05032469
Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal
A study testing Reflexology in people with Chest Tube Removal and Heart; Surgery, Heart, Functional Disturbance as Result, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Chest Tube Removal, Heart; Surgery, Heart, Functional Disturbance as Result, Pain
- What is being tested?
- Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2018to 25 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Ankara Hospital
Ankara, Çankaya, 06490
About this study
Official title: Effect of The Foot Reflexology Applied Before Chest Tube Removal on the Pain And Anxiety Level: A Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Chest Tube Removal, Heart; Surgery, Heart, Functional Disturbance as Result, Pain, Anxiety
- Being tested
- Reflexology
- Keywords
- Anxiety, Cardiac surgery, Chest tubes, Nursing, Pain, Reflexology
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Reflexology |
| Standart Care | No intervention | Participants in the control group will receive standart postoperative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale Change
Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)
Measured: 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).
Measured: 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
Numerical Satisfaction Evaluation Form includes values ranging from 0 (I am not satisfied), 10 (I am satisfied)
Measured: Second postoperative day
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.
Measured: Second postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start30 Nov 2018
- Primary completion30 Jul 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest Tube RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Elif BUDAK ERTÜRK, Baskent University
- Investigators
- Elif BUDAK ERTÜRK, MsN,RN, PhD, Principal investigator, Başkent University, Faculty of Health Science, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032469
- Sponsor's protocol ID
- 24074710-38
- Status last verified
- Jul 2023
- First submitted
- 20 Aug 2021
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of The Foot Reflexology Applied Before Chest Tube Removal on the Pain And Anxiety Level: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05032469
- Acronym / sponsor ID
- 24074710-38
- Conditions
- Chest Tube Removal, Heart; Surgery, Heart, Functional Disturbance as Result, Pain, Anxiety
- Keywords
- Anxiety, Cardiac surgery, Chest tubes, Nursing, Pain, Reflexology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refloxology Intervention | Experimental | Other: ReflexologyThe 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. |
| Standart Care | No intervention | –Participants in the control group will receive standart postoperative care. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReflexologyReflexology 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 | Other | Refloxology Intervention |
Primary outcome
Numeric Pain Rating Scale Change
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
Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)
Profile of Mood States Scale Tension-Anxiety Subscale Change
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
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).
2 secondary outcomes
Numerical Satisfaction Evaluation Form
Time frame: Second postoperative day
Form to determine the feelings and thoughts of the patients about reflexology application and chest tube removal
Time frame: Second postoperative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Chest Tube Removal
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The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters
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Effects of Vibration and Breathing Exercises on Pain and Anxiety During Chest Tube Removal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif BUDAK ERTÜRK, MsN,RN, PhD principal investigator
Başkent University, Faculty of Health Science, Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology in people with Chest Tube Removal and Heart; Surgery, Heart, Functional Disturbance as Result, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale Change (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.