Menthol Massage for Post-Bypass Pain & Anxiety

NCT07508371 | Not Yet Recruiting

• 1 other identifier: cmurali
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bypass, Cardiopulmonary

Keywords

massage; menthol; anxiety; pain

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (4)

• Pulse Rate

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

• Blood Pressure

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

• Respiratory Rate

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

• Body Temperature

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

Study Arms (3)

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.

Other: Menthol Massage

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.

Other: Massage

Group 3

NO INTERVENTION

Two doses of analgesia are administered in the clinic. No additional intervention will be performed in the control group.

Interventions

Menthol Massage OTHER

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

Group 1

Massage OTHER

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

Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

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

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  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.

  PMID: 36217996 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.

  PMID: 34304586 BACKGROUND

• Galao-Malo, R., Davidson, A., D'Aoust, R., Baker, D., Scott, M. & Swain, J. (2024). Implementing an evidence-based guideline to decrease opioids after cardiac surgery. Journal of the American Association of Nurse Practitioners, 36(4), 241-248. https://doi.org/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.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Muzeyyen Ataseven, PhD

  Medipol University

  STUDY DIRECTOR

• Cagla Murali, Master Student

  Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muzeyyen Ataseven, PhD

CONTACT

+09 444 8 544; muzeyyenataseven@hotmail.com

Cagla Murali, Master student

CONTACT

cagla.murali@std.medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: While the researchers and patients could not be blinded due to the feasibility of the study, the outcome assessor was blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Group 1: Back massage with mentholated ointment (Vicks), Group 2: Back massage with paraffin oil, Group 3 (Control): Routine clinical treatment

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: April 2, 2026
• Study Start (Estimated): September 25, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

TU (1)