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This randomized controlled trial aims to evaluate the effectiveness of mentholated ointment massage in reducing pain and anxiety levels in patients who have undergone coronary bypass surgery, volunteered to participate in the study, and met the inclusion criteria.
Group 1: Back massage with mentholated ointment (Vicks) Group 2: Back massage with paraffin oil Group 3 (Control): Routine clinical treatment The comparison group consists of the group receiving a back massage with paraffin oil and the control group (routine clinical treatment).
The questions it aims to answer are:
H1: Back massage with mentholated ointment after coronary artery bypass graft surgery reduces back pain levels compared to patients receiving routine treatment.
H2: Back massage with paraffin oil after coronary artery bypass graft surgery reduces back pain levels compared to patients receiving routine treatment.
H3: Back massage with mentholated ointment after coronary artery bypass graft surgery reduces anxiety levels compared to patients receiving routine treatment.
H4: Back massage with paraffin oil after coronary artery bypass graft surgery reduces anxiety levels compared to patients receiving routine treatment.
H5: Back massage with mentholated ointment after coronary artery bypass graft surgery reduces back pain levels compared to back massage with paraffin oil.
H6: Back massage with mentholated ointment after coronary artery bypass graft surgery reduces anxiety levels compared to back massage with paraffin oil.
Pain intensity and vital signs will be monitored in all participants before surgery, at 0 minutes (before analgesia administration), and at 30 minutes after surgery. Additionally, vital signs will be observed before the back massage at 0 minutes and after at 15 minutes. Anxiety levels will be measured before surgery and 15 minutes after the back massage application. A total of 5 back massage applications will be performed until the patients are discharged.
Coronary artery bypass graft surgery (CABG) is a frequently preferred surgical treatment method for coronary artery disease (CAD). After surgery, patients experience complications such as pain and anxiety associated with sternotomy. Reducing pain and anxiety levels in the postoperative period may be effective in speeding up the discharge process for patients. Back pain after sternotomy is a significant source of concern for patients who have undergone heart surgery. Galao-Malo states that pain often radiates from the sternum to the sides of the chest and eventually to the back, where it may become more musculoskeletal in nature. Additionally, the surgical approach itself, the patient's position during surgery, and the resulting tension in the back and shoulders can contribute to musculoskeletal pain. Studies have shown that inadequate pain control in the postoperative period can exacerbate these problems and lead to chronic pain syndromes. Both pharmacological and non-pharmacological methods are used in postoperative pain management. Massage is effective in reducing patients' pain levels as a non-pharmacological method. A study by Sözen determined that foot massage has a positive effect on reducing postoperative pain levels. In addition, massage increases blood flow and reduces pain levels by promoting the release of endorphins. For this reason, massage therapy is recommended for managing pain symptoms after CABG. This study aims to investigate the effect of post-operative back massage with mentholated ointment and paraffin oil on pain and anxiety levels in patients who have undergone coronary artery bypass graft surgery. It is anticipated that the data obtained will contribute to evidence-based practices and promote the wider use of non-pharmacological methods for pain and anxiety management by nurses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Two doses of analgesia are administered at the clinic. Massage therapy will be applied as an additional method between analgesia applications. A 15-minute back massage will be performed using mentholated ointment. |
|
| Group 2 | Placebo Comparator | Two doses of analgesia are administered at the clinic. Massage therapy is used as an additional method between analgesic applications. A 15-minute back massage is performed using paraffin oil. |
|
| Group 3 | No Intervention | Two doses of analgesia are administered in the clinic. No additional intervention will be performed in the control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menthol Massage | Other | A 15-minute back massage with mentholated ointment will be applied after coronary bypass surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effect of massage intervention after coronary bypass surgery on pain levels will be evaluated at 0 and 15 minutes. | The effect of massage intervention after coronary bypass surgery on pain levels will be assessed at 0 and 15 minutes. The NRS scale will be used to assess pain, with 0 indicating no pain and 10 indicating the highest level of pain. | Patients undergo treatment in the ward for 5 days after coronary bypass surgery. Massage therapy will be administered for a total of 5 days until discharge. |
| Anxiety | Anxiety will be assessed 15 minutes after each massage session using the State Anxiety Scale. Scores range from 20 to 80, with lower scores indicating less anxiety and higher scores indicating greater anxiety. | The effect of massage on anxiety levels in patients following coronary bypass surgery will be measured using the State Anxiety Scale 15 minutes after massage. Patients remain in the ward for 5 days after surgery and are then discharged. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Rate | Pulse rate will be measured before surgery, before analgesia (0 min), 30 minutes after analgesia, before massage (0 min), and 15 minutes after massage. | Measurements will be taken at predefined time points during the 5-day postoperative period. |
| Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muzeyyen Ataseven, PhD | Contact | +09 444 8 544 | muzeyyenataseven@hotmail.com | |
| Cagla Murali, Master student | Contact | cagla.murali@std.medipol.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Muzeyyen Ataseven, PhD | Medipol University | Study Director |
| Cagla Murali, Master Student | Medipol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Siyami Ersek Chest Heart and Vascular Surgery Training and Research Hospital | Istanbul | 34668 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Sözer, G.A, Altuntuğ, K. & Ege, E. (2019). Doğum ağrısı ve masaj. Akdeniz Tıp Dergisi, 5(3), 389-393. | ||
| Background | Sözen, K.K. (2020). Ayak masajının ameliyat sonrası ağrı düzeyine etkisi. KSÜ Tıp Fakültesi Dergisi, 15(2), 110-115. | ||
| 36217996 | Background | King M, Stambulic T, Servito M, Mizubuti GB, Payne D, El-Diasty M. Erector spinae plane block as perioperative analgesia for midline sternotomy in cardiac surgery: A systematic review and meta-analysis. J Card Surg. 2022 Dec;37(12):5220-5229. doi: 10.1111/jocs.17005. Epub 2022 Oct 11. | |
| 34304586 |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008405 | Massage |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Group 1: Back massage with mentholated ointment (Vicks), Group 2: Back massage with paraffin oil, Group 3 (Control): Routine clinical treatment
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While the researchers and patients could not be blinded due to the feasibility of the study, the outcome assessor was blinded.
| Massage | Other | A 15-minute back massage with paraffin oil will be administered after coronary bypass surgery. |
|
Blood pressure will be measured before surgery, before analgesia (0 min), 30 minutes after analgesia, before massage (0 min), and 15 minutes after massage. |
| Measurements will be taken at predefined time points during the 5-day postoperative period. |
| Respiratory Rate | Respiratory rate will be measured before surgery, before analgesia (0 min), 30 minutes after analgesia, before massage (0 min), and 15 minutes after massage. | Measurements will be taken at predefined time points during the 5-day postoperative period. |
| Body Temperature | Body temperature will be measured before surgery, before analgesia (0 min), 30 minutes after analgesia, before massage (0 min), and 15 minutes after massage. | Measurements will be taken at predefined time points during the 5-day postoperative period |
| Background |
| Mori M, Brooks C 2nd, Dhruva SS, Lu Y, Spatz ES, Dey P, Zhang Y, Chaudhry SI, Geirsson A, Allore HG, Krumholz HM. Trajectories of Pain After Cardiac Surgery: Implications for Measurement, Reporting, and Individualized Treatment. Circ Cardiovasc Qual Outcomes. 2021 Aug;14(8):e007781. doi: 10.1161/CIRCOUTCOMES.120.007781. Epub 2021 Jul 26. |
| 38236128 | Background | Galao-Malo R, Davidson A, D'Aoust R, Baker D, Scott M, Swain J. Implementing an evidence-based guideline to decrease opioids after cardiac surgery. J Am Assoc Nurse Pract. 2024 Apr 1;36(4):241-248. doi: 10.1097/JXX.0000000000000982. |
| Background | Yıldırım, F., Amanvermez Şenarslan, D., Bayram, B., Kurtal A.T., Karaaslan Yüksel, Ö. & Tetik, Ö. (2022). Tek damar off-pump ve on-pump koroner arter cerrahisinin postoperatif komplikasyonlara etkisi. Manisa Celal Bayar Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi, 9(1), 131-135. |
| Background | Duman, İ., Çolak, A. & Kısacık, H.L. (2023). Koroner bypas cerrahisi sonrasında gelişen safen ven greft darlıklarına perkütan girişim yapılan hastalarda majör olumsuz kardiyovasküler olaylar ile serum fibrinojen düzeyi arasındaki ilişki. Turkish Journal of Clinics and Laboratory, 1, 105-110. |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |