Dr. Siyami Ersek Chest Heart and Vascular Surgery Training and Research Hospital
Istanbul, 34668, Turkey (Türkiye)
NCT Number: NCT07508371
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.
Trial opening soon.
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Interventional
Not applicable
Istanbul, 34668, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 15-minute back massage with mentholated ointment will be applied after coronary bypass surgery.
A 15-minute back massage with paraffin oil will be administered after coronary bypass surgery.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: Measurements will be taken at predefined time points during the 5-day postoperative period.
Pulse rate will be measured before surgery, before analgesia (0 min), 30 minutes after analgesia, before massage (0 min), and 15 minutes after massage.
Time frame: Measurements will be taken at predefined time points during the 5-day postoperative period.
Blood pressure will be measured before surgery, before analgesia (0 min), 30 minutes after analgesia, before massage (0 min), and 15 minutes after massage.
Time frame: Measurements will be taken at predefined time points during the 5-day postoperative period.
Respiratory rate will be measured before surgery, before analgesia (0 min), 30 minutes after analgesia, before massage (0 min), and 15 minutes after massage.
Time frame: Measurements will be taken at predefined time points during the 5-day postoperative period
Body temperature will be measured before surgery, before analgesia (0 min), 30 minutes after analgesia, before massage (0 min), and 15 minutes after massage.
Contact information is provided by the study sponsor or research team.
Cagla Murali, Master student
CONTACT
Muzeyyen Ataseven, PhD
CONTACT
Istanbul Medipol University Hospital
Other
The Effect of Back Massage With Mentholated Ointment After Coronary Artery Bypass Graft Surgery on Pain and Anxiety Levels
Acronym: Menthol Care
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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