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Bypass, CardiopulmonaryMenthol CareNCT07508371

Menthol Massage for Post-Bypass Pain & Anxiety

A study testing Menthol Massage and Massage in people with Bypass, Cardiopulmonary, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Bypass, Cardiopulmonary
What is being tested?
Menthol Massage and Massage
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Sep 2026to 30 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Muzeyyen Ataseven, PhD contact

+09 444 8 544

muzeyyenataseven@hotmail.com

Cagla Murali, Master student contact

cagla.murali@std.medipol.edu.tr

Turkey (Türkiye)1 site
  • Dr. Siyami Ersek Chest Heart and Vascular Surgery Training and Research Hospital

    Istanbul, 34668

Other trials in Turkey (Türkiye)

About this study

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

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).

Read more

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.

Read the detailed description

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.

Being tested
Menthol Massage, Massage
Keywords
massage, menthol, anxiety, pain
Medical subject headings
Anxiety Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Menthol MassageOther

    A 15-minute back massage with mentholated ointment will be applied after coronary bypass surgery.

  • MassageOther

    A 15-minute back massage with paraffin oil will be administered after coronary bypass surgery.

Study groups in NCT07508371
Study groupRoleWhat they receive
Group 1ExperimentalTwo 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.
Receives: Other: Menthol Massage
Group 2Placebo comparatorTwo 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.
Receives: Other: Massage
Group 3No interventionTwo doses of analgesia are administered in the clinic. No additional intervention will be performed in the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

Secondary outcomes (4)
  1. 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.

    Measured: Measurements will be taken at predefined time points during the 5-day postoperative period.

  2. Blood Pressure

    Blood pressure will be measured before surgery, before analgesia (0 min), 30 minutes after analgesia, before massage (0 min), and 15 minutes after massage.

    Measured: Measurements will be taken at predefined time points during the 5-day postoperative period.

  3. 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.

    Measured: Measurements will be taken at predefined time points during the 5-day postoperative period.

  4. 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.

    Measured: Measurements will be taken at predefined time points during the 5-day postoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2026
  2. Study start25 Sep 2026 (estimated)
  3. Primary completion25 Dec 2026 (estimated)
  4. Study completion30 Jan 2027 (estimated)

Resources

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
Sequential
Model description
Group 1: Back massage with mentholated ointment (Vicks), Group 2: Back massage with paraffin oil, Group 3 (Control): Routine clinical treatment
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07508371
Sponsor's protocol ID
cmurali
Acronym
Menthol Care
Status last verified
Mar 2026
First submitted
15 Sep 2025
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

Questions about this trial

What is this clinical trial studying?

A study testing Menthol Massage and Massage in people with Bypass, Cardiopulmonary, run by Istanbul Medipol University Hospital 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 10 inclusion and 12 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: opening soon, as of the sponsor's last update on 2 Apr 2026. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Muzeyyen Ataseven, PhD (+09 444 8 544, muzeyyenataseven@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect of massage intervention after coronary bypass surgery on pain levels will be evaluated at 0 and 15 minutes. (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 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?

On the ClinicalTrials.gov record for NCT07508371, which also lists 7 linked publications.

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 2 Apr 2026.

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