Menthol Massage for Post-Bypass Pain & Anxiety (Menthol Care)

March 30, 2026 updated by: muzeyyen ataseven, Istanbul Medipol University Hospital

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).

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34668
        • Dr. Siyami Ersek Chest Heart and Vascular Surgery Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
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
A 15-minute back massage with mentholated ointment will be applied after coronary bypass surgery.
Placebo Comparator: Group 2
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
A 15-minute back massage with paraffin oil will be administered after coronary bypass surgery.
No Intervention: Group 3
Two doses of analgesia are administered in the clinic. No additional intervention will be performed in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse Rate
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.
Measurements will be taken at predefined time points during the 5-day postoperative period.
Blood Pressure
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.
Measurements will be taken at predefined time points during the 5-day postoperative period.
Respiratory Rate
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.
Measurements will be taken at predefined time points during the 5-day postoperative period.
Body Temperature
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.
Measurements will be taken at predefined time points during the 5-day postoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Study Director: Muzeyyen Ataseven, PhD, Medipol University
  • Principal Investigator: Cagla Murali, Master Student, Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 25, 2026

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

September 15, 2025

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cmurali

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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