Coronary Artery Bypass Graft Surgery (CABG)NCT06688617
Effect of Swedish Hand Massage on Pain in Patients Undergoing CABG Surgery
A study testing Swedish Hand Massage in people with Coronary Artery Bypass Graft Surgery (CABG) and Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Coronary Artery Bypass Grafting (CABG) surgery is performed commonly today. Heart surgery performed on more than two million individuals every year leads patients experience severe postoperative pain for causes such as cutting of intercostal nerves along the incision line, pleural irritation caused by thoracic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery (CABG), Pain, Pain Management
- What is being tested?
- Swedish Hand Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2018to 30 Apr 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent CABG surgery,
- Stated that they were in pain,
- 18 years old and older,
- Had not completed 48 hours after the surgical procedure,
- Accepted to participate in the study verbally and in writing after being informed about the study,
- Could understand the information given,
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- Could read, write and speak Turkish,
- Did not have any physiological, psychological or mental problems that would prevent verbal communication,
- Did not have any limb, vascular problem, wound or catheter that would prevent the application of hand massage,
- were ASA classified as I and II,
- Had no previous hand massage experience,
- Did not participate in any other clinical studies during the same period,
- Did not develop any complications during and after the surgical procedure,
- Physiological parameters were within normal limits during the surgical procedure,
- Received the same type of treatment in the post-surgical period,
- Body mass index was within normal limits
Who cannot join
- Patients who have complications during or after surgical intervention,
- Intubated,
- Have any limb, vascular problem, wound or catheter that prevents hand massage,
- Under the effect of pharmacological or non-pharmacological interventions that will affect pain,
- Obese (body mass index (BMI≥30),
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpaşa
Istanbul, Şişli
About this study
Official title: Effect of Swedish Hand Massage on Pain in Patients Undergoing Coronary Artery Bypass Graft Surgery: Randomized Controlled Trial
Coronary Artery Bypass Grafting (CABG) surgery is performed commonly today. Heart surgery performed on more than two million individuals every year leads patients experience severe postoperative pain for causes such as cutting of intercostal nerves along the incision line, pleural irritation caused by thoracic catheters etc. Hand massage, which is one of the non-pharmacological methods, is an effective procedure that can be applied independently by nurses for pain management. The objective of this randomized controlled study is to investigate the effect of hand massage applied to the patients with CABG surgery during the postoperative intensive care process, on pain.
- Conditions
- Coronary Artery Bypass Graft Surgery (CABG), Pain, Pain Management, Nursing, Massage, Hand Massage
- Being tested
- Swedish Hand Massage
- Keywords
- Coronary Artery Bypass Graft, Hand Massage, Swedish Massage, Pain, Nursing
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swedish Hand MassageOther
Swedish technique hand massage: Effleurage-petrissage-friction-tapotement,-vibration-effleurage
| Study group | Role | What they receive |
|---|---|---|
| Swedish hand massage | Experimental | Swedish hand massage was applied to patients who were extubated after the first 4 hours after surgery, were not under the effect of pharmacological or non-pharmacological analgesia, and were in the intensive care period after the first expression of pain. Receives: Other: Swedish Hand Massage |
| Control | No intervention | Patients who were extubated within the first 4 hours after surgery, who were not under the effect of pharmacological or nonpharmacological analgesia, and who were admitted to the intensive care unit with the first pain symptom were followed up during the follow-up periods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sternotomy pain
Measured: Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
Drain pain
Measured: Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
Back Pain
Measured: Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
Leg incision pain
Measured: Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
Secondary outcomes (5)
Systolic blood pressure
Measured: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Diastolic blood pressure
Measured: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Pulse rate
Measured: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Respiratory rate
Measured: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Oxygen saturation
Measured: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start30 Apr 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft Surgery (CABG)Studies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Responsible party
- Principal investigator, Oyku Kara, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688617
- Sponsor's protocol ID
- 3435-19
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect the rights of patients, an undertaking was given to the Ethics Committee that the data would not be shared with anyone other than the researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Swedish Hand Massage on Pain in Patients Undergoing Coronary Artery Bypass Graft Surgery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06688617
- Acronym / sponsor ID
- 3435-19
- Conditions
- Coronary Artery Bypass Graft Surgery (CABG), Pain, Pain Management, Nursing, Massage, Hand Massage
- Keywords
- Coronary Artery Bypass Graft, Hand Massage, Swedish Massage, Pain, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 14 Nov 2024 (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.
Coronary Artery Bypass Grafting (CABG) surgery is performed commonly today. Heart surgery performed on more than two million individuals every year leads patients experience severe postoperative pain for causes such as cutting of intercostal nerves along the incision line, pleural irritation caused by thoracic catheters etc. Hand massage, which is one of the non-pharmacological methods, is an effective procedure that can be applied independently by nurses for pain management. The objective of this randomized controlled study is to investigate the effect of hand massage applied to the patients with CABG surgery during the postoperative intensive care process, on pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Swedish hand massage | Experimental | Other: Swedish Hand MassageSwedish hand massage was applied to patients who were extubated after the first 4 hours after surgery, were not under the effect of pharmacological or non-pharmacological analgesia, and were in the intensive care period after the first expression of pain. |
| Control | No intervention | –Patients who were extubated within the first 4 hours after surgery, who were not under the effect of pharmacological or nonpharmacological analgesia, and who were admitted to the intensive care unit with the first pain symptom were followed up during the follow-up periods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients who underwent CABG surgery,
- Stated that they were in pain,
- 18 years old and older,
- Had not completed 48 hours after the surgical procedure,
- Accepted to participate in the study verbally and in writing after being informed about the study,
Key exclusion criteria (5 listed)
- Patients who have complications during or after surgical intervention,
- Intubated,
- Have any limb, vascular problem, wound or catheter that prevents hand massage,
- Under the effect of pharmacological or non-pharmacological interventions that will affect pain,
- Obese (body mass index (BMI≥30),
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 |
|---|---|---|
| Swedish Hand MassageSwedish technique hand massage: Effleurage-petrissage-friction-tapotement,-vibration-effleurage | Other | Swedish hand massage |
Primary outcome
Sternotomy pain
Time frame: Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
Drain pain
Time frame: Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
Back Pain
Time frame: Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
Leg incision pain
Time frame: Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.
5 secondary outcomes
Systolic blood pressure
Time frame: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Diastolic blood pressure
Time frame: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Pulse rate
Time frame: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Respiratory rate
Time frame: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
Oxygen saturation
Time frame: Evaluated with a patient monitor before and after the massage at 5, 30, 60, 90, 90 and 120 minutes.
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 14 Nov 2024.
- Individual participant dataSharing planned: No. In order to protect the rights of patients, an undertaking was given to the Ethics Committee that the data would not be shared with anyone other than the researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swedish Hand Massage in people with Coronary Artery Bypass Graft Surgery (CABG) and Pain, run by Istanbul University - Cerrahpasa 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 16 inclusion and 5 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 14 Nov 2024. 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?
Sternotomy pain (time frame: Pain intensity was assessed with a visual analog scale (VAS) before and at 5, 30, 60, 90, 90 and 120 minutes after massage.). The study lists 4 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 14 Nov 2024.