Menthol Massage for Post-Bypass Pain & Anxiety

Официальное название

The Effect of Back Massage With Mentholated Ointment After Coronary Artery Bypass Graft Surgery on Pain and Anxiety Levels

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Menthol Massage
  A 15-minute back massage with mentholated ointment will be applied after coronary bypass surgery.
• Другое Massage
  A 15-minute back massage with paraffin oil will be administered after coronary bypass surgery.

Первичные конечные точки

• The effect of massage intervention after coronary bypass surgery on pain levels will be evaluated at 0 and 15 minutes. [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (4)

• Pulse Rate [Срок оценки: Measurements will be taken at predefined time points during the 5-day postoperative period.]
• Blood Pressure [Срок оценки: Measurements will be taken at predefined time points during the 5-day postoperative period.]
• Respiratory Rate [Срок оценки: Measurements will be taken at predefined time points during the 5-day postoperative period.]
• Body Temperature [Срок оценки: Measurements will be taken at predefined time points during the 5-day postoperative period]

Критерии участия

Критерии включения

• Willing to participate in the study,
• Who has undergone bypass surgery,
• Aged 18 years or older,
• No visual impairment (except those who can see better with visual aids), hearing impairment (except those who can hear better with hearing aids), or speech impairment/communication problems that would prevent them from understanding the information provided and accurately describing their pain,
• Literate,
• Possesses orientation to person, place, and time,
• Has a sternum exposure time of at least 2 hours during surgery,
• Does not use any complementary alternative medicine methods,
• Meets ASA 1 and ASA 2 criteria,
• Elective (planned) surgery patients will be included.

Критерии исключения

• Individuals with allergies to menthol ointment and paraffin oil used during the procedure,
• Individuals participating in a different study conducted at the clinic,
• Individuals experiencing confusion,
• Individuals with physical and cognitive problems that prevent massage from being applied,
• Individuals diagnosed with mood disorders (depression, panic attacks, dysthymia, bipolar disorder, or taking any medication for these conditions),
• Individuals with respiratory problems,
• Individuals who cannot speak Turkish, and cannot read or write Turkish
• Transferred to intensive care during the postoperative period,
• Experiencing severe bleeding, hematoma, seroma, or nerve injury during the postoperative period,
• Developing an allergy to mentholated ointment/paraffin oil used during massage,
• Voluntarily requesting to leave the job,
• Individuals who do not comply with the work process and conditions will be removed from the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Dr. Siyami Ersek Chest Heart and Vascular Surgery Training and Research Hospital — Istanbul

Публикации

• Sözer, G.A, Altuntuğ, K. & Ege, E. (2019). Doğum ağrısı ve masaj. Akdeniz Tıp Dergisi, 5(3), 389-393.
• Sözen, K.K. (2020). Ayak masajının ameliyat sonrası ağrı düzeyine etkisi. KSÜ Tıp Fakültesi Dergisi, 15(2), 110-115.
• 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. PMID 36217996
• 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. PMID 34304586
• 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. PMID 38236128
• 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.
• 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.

Идентификаторы

NCT: NCT07508371 · cmurali

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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